Since 2003, the mission of BioProcess International has been to connect biopharmaceutical scientists and decision makers to the science, technology, and expertise that can positively influence and improve existing bioprocesses. Our BioProcess International Awards were created in 2012 to mark the magazine’s 10-year anniversary. They allow us to reflect on and help honor the time and investment companies put into researching, developing, and launching biopharmaceutical products, technologies, and services to deliver better, more efficient treatments and increased hope to a global patient base.
To date, these biennial awards have recognized more than 50 winners who represent excellence in leadership, corporate citizenship and collaborations, innovative facility design, emerging companies, and best application of technologies in upstream and downstream processing and analytical methods. The BPI Awards also singles out individuals who personally challenge the biopharmaceutical industry as a whole to rethink, reinvent, and improve itself.
The 2016 BioProcess International Awards continues this tradition. A record number of truly inspiring nominations this year challenged our 16-member independent judging panel (whose names appear here to the left). They evaluated and assigned a value to each nomination based on specific criteria that we provided. Each nomination was assessed according to the same five elements: applicability, innovation, results, industry impact, and sustainability. We are indebted to the judging panel and thank them for the time and dedication invested.
2016 BPI Awards Judges
|BPI is grateful to this panel of judges for reviewing and scoring the nominations. Each judge reviewed all the entries in his or her assigned category.
Vishal Agrawal (scientist II, BioMarin Pharmaceutical)
Alain Fairbank (industry consultant)
Sid Jain (senior manager, CMC operations and logistics, Regeneron)
Dave Jensen (executive recruiter, CTI Executive Search) Daniella Kranjac (president, Dynamk Consulting)
Bryan Monroe (principal, Primus Consulting)
Brian Nunnally (director, global stability, Biogen)
T. Shantha Raju (senior director, MedImmune)
Tom Ransohoff (vice president and principal consultant, BioProcess Technology Consultants)
Tiffany Rau (head of innovation management, Evonik Degussa)
Nadine M. Ritter (president and analytical advisor, Global Biotech Experts, LLC)
Gil Roth (president, Pharma and Biopharma Outsourcing Association)
Kristi Sarno (senior consultant, Latham Biopharm Group)
Zahra Shahrokh (CMC consultant, Zdev Consulting)
Robert Speziale (principal consultant, SCS)
Mike Ward (editor in chief, Scrip)
After 18 months of preparation, BioProcess International announced its finalists for 2016. This exclusive group represents the best that the biopharmaceutical industry has to offer. At the 13th BioProcess International Conference in Boston, MA, on the evening of 5 October 2016, we hosted a banquet and ceremony to honor all participants and introduce the winners — including Mark Petrich our 2016 industry champion. We thank our event sponsors for their support of our festive and well-attended event (Figure 1).
BPI publisher Brian Caine began the program with a short historical perspective, looking back to the magazine’s founding and then forward to its 15-year anniversary in 2017. “The BPI brand has come a long way since May of 2002. After over two years of planning, the four original partners agreed to join Informa and launch what you now know as BioProcess International.
“Despite the best of planning, there are always bumps along the way in launching new products. During our pitch meetings, we used the name ‘Bio-X’ for this project because we knew we were creating something unique and special. Looking back, it was a really exciting time. After we signed the deal with Informa, our final task was to agree upon an official name for the publication.” In the late 1990s and early 2000s, development and manufacturing of biologics were still characterized by independent processing silos. “So we wanted to create a name that clearly defined the publication’s mission about where we believed the industry needed to go: BioProcess International with the tagline, ‘covering the whole development process for the global biotechnology industry.’”
As Caine explained, the founders thought that was the perfect name to help encourage the industry to keep thinking about development as a larger, multistep process instead of many separate processes — among which processing is just one step. So they introduced the concept and name to a number of their trusted advisors and industry friends.
The responses were unanimously negative: “Bioprocess?” “It’s too broad. . . I’m not sure what that really means.” “I really like you guys, but I hate to tell you: That name will never work.” At the time, it was a bit depressing. The biopharmaceutical industry was only about 20 years old and made up of what many now refer to as “the first generation”: that early group of scientists who stepped away from the small-molecule market and academia to create a new industry built largely upon the as-yet unproven promise that living cells could produce the therapeutic wave of the future. But as Caine explained, “Ultimately, we decided to trust our instincts, take a blind leap, and move forward with BioProcess International.
“In many ways,” Caine said, “our story represents just how fast-paced this industry moves. Think about it: 15 years ago, the term bioprocess didn’t make sense to a lot of really smart people. Today, it defines the direction of an industry.” This reminds us why it’s critical to stay ahead of the latest trends and techniques and continuously look for ways to improve research and development and current processes.
“It’s why we created the BioProcess International Awards in 2012. Over those first 10 years, we experienced firsthand how demanding, unrelenting, and fast-paced this business is — and we wanted to create a platform where we all could acknowledge the advancements and accomplishments that the industry has made.” These awards can shine a bright light on what really drives those advancements: the individuals, the collaborations, the partnerships, and companies that consistently challenge the biopharmaceutical industry to never accept what works well as good enough.
The 2016 BioProcess International Awards continues that tradition. “Each of tonight’s finalists have earned the right to be here,” Caine emphasized. “Although there is only one winner in each category, all the finalists and nominees are responsible for helping to drive innovation and progress.” Here we honor individual excellence in leadership with a short list of people who are recognized as exceptional leaders with relentless motivation and vision. We introduce the market to emerging companies that are poised to significantly change how the biopharmaceutical industry conducts its business. We recognize companies that “walk the walk” and put their money on the line to rethink and redesign how facilities can and should operate to make treatments faster and less expensively without sacrificing quality. We tip our caps to companies that make giving back and being active members of their local and global communities a priority. We also know that there is no “I” in progress, so we recognize collaborations that combine expertise to improve the odds for success. And where would the industry be without the vision and leadership of its technology suppliers? They provide expertise and thought leadership that help sponsors pursue therapeutic projects once considered financially unjustifiable.
Industry Champion: This is the one award in the program that does not involve our external judging panel. As editor in chief Anne Montgomery put it, “We may ask for recommendations throughout the 18 months between awards programs, but when the time comes to make our final decision, we have clear criteria to help us sort through the choices. We look for those who have worked with us to educate the biopharmaceutical industry in any number of ways. Some have led us to explore topics editorially that we’d not thought about before. Others provide key leadership within an industry organization or consortium. We look for those whose vision is not limited to a specific process phase, but who can place their work in a larger context, seeking out interconnected applications, finding or creating synergies that may not have been recognized before, and doing their best to positively disrupt the status quo.”
The biopharmaceutical industry boasts many champions, some well-known, whereas others work behind the scenes to drive significant progress. We looked for someone who offers a clear vision that drives a company, technology, or manufacturing paradigm into the future, rethinking ways to bring needed therapies to the global markets. We look for someone who has especially exemplified the spirit of collaboration, who can step outside the usual focus on individual company goals and encourage others to develop a broader vision of possibilities and concrete strategies.
At this year’s ceremony we honored Mark Petrich, director of component engineering at Merck & Co. One of our 2014 industry champions, James Vogel (founder and director of The Bioprocess Institute), stepped up to talk about Petrich and his work to bridge the gaps between the present and the future of biomanufacturing. Vogel has worked as a director, project manager, and engineer with Amgen, GlaxoSmithKline, ImClone, Sanofi-Pasteur, Lipton, and Avon. We at BPI have come to know him through his efforts to further the progress of single-use technologies through participation in industry organizations.
Vogel began by introducing the industry champion’s background. Before joining Merck, Petrich was assistant professor of chemical engineering at Northwestern University, where he held the ME Fine Junior Professor in Materials and Manufacturing chair. He has BS and PhD degrees in chemical engineering from Washington University in St. Louis, MO, and the University of California at Berkeley, respectively. He is also a member of the single-use workstream leadership team for the BioPhorum Operations Group (BPOG).
A Visionary Focus: Vogel emphasized that a key factor in BPI’s selection of Petrich as 2016 industry champion is his work in promoting single-use technologies with a visionary focus beyond the industry’s current capabilities. Within the Merck network he promotes education and communication regarding disposable components to a broad network of end users and clients. With their input and his own forward-looking perspective, Petrich focuses on expanding engagement with disposable materials into a vision of manufacturing processes for the future.
“It is a great honor to present Mark Petrich with the 2016 BioProcess International Industry Champion award,” said Vogel. “I can think of no one who deserves it more. Mark has been an engineer, scientist, manager, and director with Merck and its business ventures for many years.” His successes there are many:
- as a sterile pilot-plant manager, helping to make clinical materials on numerous products
- as a research fellow, helping with Rosetta Inpharmetics in Washington to interface with Merck
- as a process engineer, using his experience to help Merck apply new technologies such as disposables
- as director of component engineering, helping Merck to lead in single-use technologies.
“I have personally seen this leadership,” Vogel went on. “Not ‘We are big pharma, and we know the right way!’ But rather a stabilizing, understanding, balanced leadership to ensure that technical needs are met along with business needs. And most important: for the needs of the community at large and all parties involved.”
Vogel explained that he had served as the first end-user chairman for the Bio-Process Systems Alliance (BPSA), where his role was to help suppliers understand how single-use products are used and highlight other common end-user issues. He eventually needed to find a “real end user” who could ultimately take over his position. “At my first end-user meeting, Mark was one of the three end users in attendance, and he effectively convinced the BPSA board to start a particulates project for ‘the biggest pain’ in the industry.”
Vogel later nominated Petrich to succeed him as end-user chairman of BPSA, and Mark is now vice chair of the organization. “Mark can approach almost any issue effectively and calmly to make all parties feel comfortable — or at least less threatened. This is especially clear with his efforts in single-use technologies.” Merck is a leader in this area: establishing a component engineering group, having a product show for suppliers, and effectively implementing disposables. Petrich has led many of these efforts.
He also has been a voice in what Vogel called “the alphabet soup of single-use standardization for the community at large.” In July 2016, Petrich nonconfrontationally delivered the BPOG disposables workstream’s vision at the BPSA Summit to enlist community support.
“I see it as a real honor to know Mark and to work with him,” said Vogel, as he invited our industry champion to the podium.
In his gracious acceptance, Petrich admitted, “I think my best accomplishment is definitely the people who have worked on my team who have developed in their careers. Strange as it may seem to say, the ones who leave and move on to bigger and better roles are the ones that I’m most proud of. Again, it may sound a little bit strange, but my long-term goal is not to have this role any more. What we’ve been striving to do is standardize single-use technology and make it easier to deploy. If we are really successful, you won’t need a specialist group like us anymore.”
The Excellence in Leadership Award recognizes an individual (regardless of his or her company’s organizational hierarchy) who has shown excellent leadership skills. This year’s finalists were Marcel Bassil (associate director of biotech at Benta Pharm Industries) and Olivier Loeillot (general manager of GE Healthcare). Their achievements have established them as strong leaders and/or mentors. Their key leadership skills help their respective businesses achieve operational excellence. They demonstrate strong visions to drive their companies to greater commercial success and motivate their teams for growth and innovation.
This year’s winner is Igor Fisch (chief executive officer at Selexis). He has been the Selexis CEO since the company’s founding in 2001. Fisch helped build it from a spin-out of the University of Lausanne (Switzerland) into a global leader in mammalian cell-line generation. He is an innovator, a scientist, and a strong example of a biotechnology business leader who has built a successful business from a university technology-transfer asset.
Fisch sets the company’s business strategy and empowers his team to achieve their goals. He sets the vision for the future growth areas of the company and then works with his board to obtain financing and resources to realize that vision. His scientific vision has driven the growth of the Selexis technology pipeline — and consequently, the growth of the company itself. In the past year, revenues grew by 30%. As a scientist and a visionary, Fisch plays an important role in educating current and potential partners about the science behind and the utility of his company’s inventions.
Fisch’s greatest single achievement has been to build a culture within Selexis that has fostered development of a suite of recognized world-class, innovative cell-line development technologies. He has achieved that by recognizing and hiring talent, supporting employees with necessary tools and time (outside of their client work) for experimentation, and having the vision and market savvy to know which of their innovations will have the biggest impact in the field. Since its inception, Selexis has been a top innovator in both cell-line development and biologic drug discovery, consistently outpacing competitors in the number of innovations brought to market. It has 143 patents; more than 65 clinical programs use manufacturing cell lines generated by Selexis technology.
Fisch sets the vision for the organization and then empowers his teams to execute on that vision. He welcomes and expects feedback from them on their plans for reaching that vision. He gives his employees the freedom to try new ideas and accepts that not all ideas work. He recognizes the importance of job satisfaction in retaining top talent and readily supports career moves within the company. He has set up a business structure so that everyone (not just sales teams) financially benefits from sales and deal closings. Fisch builds and fosters teams that are passionate about their work and are committed to seeing the company succeed. The average tenure of Selexis employees is eight years, which translates into very experienced people working on their clients’ important projects.
In addition to building his own company, Fisch helps other entrepreneurs build theirs. He has worked for eight years as a strategy board member for the Venture Kick Initiative in Switzerland, where he provides feedback/assessment on start-ups coming out of Swiss universities and experienced know-how to the entrepreneurs launching those new businesses.
“I am very honored to receive this recognition from such a very well-respected and experienced industry source as BioProcess International,” he told us. “This award is truly a reflection of the tremendous group of people at Selexis that support me and the important work in which we collectively engage as an organization. Just as our company enables cell-line development services that help our biopharmaceutical partners identify and deliver innovative therapies to patients, my team enables me to do my best work daily. I also extend my congratulations to all of the finalists in this year’s program, who also have led their teams to accomplish critical work for the biopharma industry.
“Leaders have to make sure that people believe in their innovations to bring them forward. So I think that leadership is helping people get where they need to go. The key element for the success of Selexis is how we can bring more drugs to the patients. Basically, the elements are based on innovation and how we can translate innovative new medicines to cure patients.”
The Emerging Company Award recognizes companies to watch in the industry. They have new technologies that already are seeing significant industry adoption, or they have innovative business or partnering models worthy of emulation. These companies have successfully raised awareness within the scientific community and continue to do so. The two finalists were Cell and Gene Therapy Catapult and Quad Technologies.
Our judges selected NuMedii, Inc., as the winner in this category. The company discovers effective new drugs by translating predictive data-intelligence technology into improved probability of therapeutic success. Originally developed at Stanford University, NuMedii’s exclusive “big data” technology uses large amounts of scientific data together with proprietary biological-network–based algorithms to discover drug–disease connections and biomarkers predict efficacy. The company translates its predictions into novel derisked drug candidates and partners with pharmaceutical companies for their development and commercialization.
NuMedii’s proprietary and dynamic Big Data Platform technology includes hundreds of millions of raw human, biological, pharmacological, and clinical data points that are normalized and annotated. The company integrates those data with proprietary network-based algorithms to find both drug candidates and biomarkers with predictive efficacy for disease treatment. Using genomic databases, integrated knowledge sources, and bioinformatic approaches, NuMedii can discover novel uses for known drugs quickly. It then leverages safety data for those drugs in their original use to get to clinical trials quickly and economically.
“We are pleased to be acknowledged for our company’s contributions to help discover new uses for medicines that ultimately will benefit patients in need,” said Gini Deshpande, PhD, NuMedii’s chief executive officer. “Receiving the BioProcess International award for Best Emerging Company underscores our efforts to revolutionize drug discovery by translating big data into pipeline drug candidates with a higher probability of success.”
The Corporate Citizenship Award recognizes a company that has made significant contributions through activities within its broader local, regional, and/or global community. Through the involvement of their employees, these companies are well respected for their significant achievements within their local communities and the world at large. Finalists were Baxter (for the Baxter International Foundation) and Biogen (for closing the hemophilia gap in the developing world).
The winning nominee was GlaxoSmithKline for its PULSE partnership. Natalie Woodford (GSK’s senior vice president of talent, leadership, and organization development) describes the program as a flagship skills-based volunteering initiative in which employees lend their expertise to help nonprofit organizations. Over the past six years, PULSE has provided some US$23 million worth of skilled services to GSK’s partners (as calculated by multiplying the average salary and benefits cost of an employee by the amount of time volunteers served on their assignments).
The PULSE Volunteer Partnership has a threefold mission:
- To change communities (“Our employees create positive, sustainable change for nonprofit partners and the communities they serve.”)
- To change employees (“Our employees are challenged to think differently, develop leadership skills, and heighten cultural agility through their PULSE experiences.”)
- To change GSK (“Our employees bring fresh ideas and new energy back to GSK to activate change in step with global health needs.”)
Ahsiya Mencin (director of the PULSE Volunteer Partnership at GSK human resources and corporate social responsibility) says, “Since we launched the PULSE Volunteer Partnership in April 2009, 635 of our employees have shared their professional skills to deliver positive sustainable change in more than 100 nonprofit partners and communities in all corners of the world. Whether it has been building nongovernmental organization (NGO) capacity, strengthening healthcare systems, or improving cold chain supply, these employees have stepped out of GSK walls to serve and better understand the increasingly complex needs of our diverse societies. PULSE volunteers have developed their leadership skills and learning agility, broadening their perspectives and returning to GSK as better, more empathetic global leaders who help our company to stay in step with society. PULSE has become a strong symbol of GSK’s values and a deep source of pride and motivation for our >100,000 employees around the world.”
The Facility Design or Retrofit Award recognizes a facility that exemplifies innovation through the use of key technologies and/or designs. The results provide a high-quality example of energy efficiency, traffic flow (of both people and materials), conversion to single-use or flexible operations, increased automation, accommodation to local ordinances and integration with local services and policies, expansion to take on a new product line or convert to a multiproduct facility, creation of better ergonomic conditions, improved sustainability, and many other capabilities. The finalists for this award offer a high standard. They were Fujifilm Diosynth Biotechnologies (for repurposing a microbial facility for multiproduct GMP manufacturing) and Gibraltar Laboratories (for CGMP independent laboratory and sterilization services).
This year’s winner was JHL Biotech, Inc., for its installation of a KUBio biomanufacturing solution from GE Healthcare in Wuhan, China. As described by Max Chan (JHL’s chief financial officer), this is the first such installation anywhere. The 2,400-m2 plant consists of 62 prefabricated modules and a FlexFactory single-use platform in a two-story building with a footprint of roughly 1,200 m2. Level 1 is the manufacturing space, and Level 2 is used for heating, ventilation, air conditioning (HVAC) and storage. Some additional space is used for supporting infrastructure, including QA facilities.
JHL plans to use this facility to make ≤100 kg of monoclonal antibodies (MAbs) in 2,000-L single-use bioreactors each year. Initially, four 2,000-L bioreactors have been installed. The modules were prebuilt in Germany, then transported to China, where they were assembled in eight days. The facility became operational within 18 months — significantly faster than the three-year development timeline typical in the biopharmaceutical industry.
The JHL KUBio facility design was optimized to provide efficient use of space and process flow using the FlexFactory single-use manufacturing platform to complement JHL’s other plant in Taiwan. The standardized modules facilitate easy scale-up from process development and early clinical manufacturing in Taiwan to late-stage clinical manufacturing and commercial production at the new site in Wuhan. Speed of construction also was a key consideration: Parallel production of KUBio modules and FlexFactory processing equipment during site preparations enabled JHL to reduce overall timelines and begin production as soon as possible. GE Healthcare managed every stage of the project to ensure that both facility and processes would be fully qualified and ready to run within 18 months of design approval.
This facility is based on a standardized and optimized design that provides an efficient manufacturing facility footprint with integrated automation that enables production proficiency. The single-use technology platform reduces demands for water for injection (WFI), process water, steam, and cleaning and sanitization in place (CIP, SIP). JHL could have used a number of different contractors for this project and managed it internally; instead, GE provided a single point of contact with experience and coordination to streamline the project in a collaborative relationship.
JHL is manufacturing in China because of a need there to increase the availability and affordability of high-quality pharmaceuticals. To help fulfill that need, JHL must be in China because the Chinese government requires that all Chinese drugs must be manufactured in China and be approved by the State Food and Drug Administration (SFDA), even for investigational new drug (IND) submissions.
At the event, Racho Jordanov (JHL’s cofounder, president, and CEO) said, “The objectives are to provide affordable medicines to the world and also to achieve that in record time. We were able to design and build a manufacturing facility in less than three years, and we are currently manufacturing products for the world in China. Implementation of single-use technology for mammalian cell culture production is what made this possible. We currently operate three different flexible factories: one in Taiwan and two in China. Having identical manufacturing processes helps with optimization very much.”
The Best Collaboration Award recognizes a number of promising collaborations that have been formed within the past 18 months and are already providing significant benefits toward accelerating drug development or mitigating risks. These companies or groups have come together to form a solid foundation for innovation and a long-term mission for accelerated growth. Finalists were the PCMM Consortium (G-CON, GEA Pharma Systems, and Pfizer) and the disruptive Cadence Acoustic Separator project (Pall Life Sciences and FloDesign).
The winning entry was the application of the FibroSelect nanofiber purification platform for industrial use by Puridify and GlaxoSmithKline. The former company spun out from University College London in 2013 to develop a step-change downstream processing technology for industrial biotherapeutic manufacture. The nomination narrative explained that high-capacity and high flow-rate properties of FibroSelect technology dramatically reduce unit operation size relative to traditional packed-bed chromatography. Ready-to-operate units reduce validation burden, improve process robustness, and improve facility flexibility.
For this project, Puridify required industrial quantities of cell-harvest material that would be accessible only through an industrial collaboration. So the technology provider has maintained a highly complementary collaboration with GSK for over a year, developing and evaluating the technology from microliter capacity to 50-L pilot scale. In the process, the two groups have shared knowledge, industrial processing concepts, and novel ideas. This initial collaboration successfully demonstrated a 50-fold increase in purification productivity, and it has been extended for a further 18 months to drive toward full industrial-scale purifying feed from >500-L bioreactors.
In addition to purification productivity, the groups identified a number of other quantitative and qualitative benefits centering on processing flexibility, ease of use, speed of processing, reduction of unit operations, and maximizing the productivity of existing and future facilities. FibroSelect technology offers a means to address many of advancements identified as critical to development of the biopharmaceutical industry, but the company needs in-depth and continuous support from major drug manufacturers to ensure development and market entry with a technology that will truly make a difference.
The FibroSelect platform was applied to three GSK early development MAb process case studies, in which it demonstrated a clear benefit over market-leading technologies. The downstream team used robotic systems at microliter through pilot scales, purifying 50 L of therapeutic MAbs from CHO cell harvests (selected to be representative of current MAb platforms at titers ranging from 0.5 to 3.0 g/L). Protein A FibroSelect nanofiber material achieved purification productivities of >450 g MAb purified per liter of adsorbent per hour, using a single cartridge on standard chromatography equipment. Compare that with just 6–15 g/L/h achievable with traditional packed-bead chromatography.
Using a multicycle, single-batch mode of operation, FibroSelect units have demonstrated an ability to match process critical quality attributes (CQAs) when cycled over 190 times for three minutes each (one-second residence times). Offering dynamic binding capacities (DBCs) of >30 mg/mL and novel housing devices with optimized fluid-flow regimes, the platform alleviates buffer use and product concentration concerns associated with high–flow-rate chromatography applications.
This collaboration already has achieved positive results, with the technology well on the way to being industrially proven. It also has allowed for extensive knowledge sharing between both teams, leading to advancements on both sides. The initial success of the collaboration has given rise to further innovative projects between the two companies in areas such as 3D bioprinting, enzyme biocatalysis, and candidate screening.
At the event, Oliver Hardick (Puridify’s chief executive officer) said, “For Puridify, it was about proving that this technology we’re developing is industrially relevant. Collaborators like GSK are critically important for us to be able to do that.”
And Ahsiya Mencin of GSK added, “I think that being on the same page in terms of knowing our goals and milestones and having the same scientific objectives really made this project move forward.”
The Best Technology Application — Upstream Award recognizes a user or supplier of a production application that offers much more than hype: It will have shown through adoption and application of an existing technology or development of its own materials and methods that it is paving the way toward a new approach to process design or a new apparatus that shows well-documented improvement over existing equipment. Finalists were Nova Biomedical’s BioProfile FLEX2 instrument and Glycotope’s Sedimentation in an Automated Microbioreactor technology.
This year’s winner is the Ranger service from Stratophase Ltd. According to Richard Hart (commercial director of Stratophase), the service provides a valuable new approach to cell culture optimization based on real-time, on-line assessment of metabolic activity. The resulting insight into the health and activity of cells is then used to direct process optimization activities. “This innovative, next-generation approach is a highly successful advance from the traditional design of experiments (DoE) methodology and has been shown to arrive at a more robust process with high productivity in less time.” The Ranger service enables an approach to cell culture process development that is centered on the cells themselves. It is based on patented hardware originating from the Optical Research Centre at the University of Southampton in Great Britain, supported by the company’s application expertise gained from working with customers’ cell culture processes.
The Ranger service measures, for the first time, changes in the metabolic rate of cell cultures on line and in real time. Resulting information informs process parameter changes to help companies keep cells in an optimally active and healthy condition. This innovative new approach in cell culture process development has provided sponsor companies with multiple benefits: more robust processes developed, shortened timelines, and improved productivity. It provides insights into the dynamics of cell culture processes that were not previously available.
The Ranger service enables process development scientists to measure changes in the metabolic rate of a cell culture and allows corresponding process parameter changes (e.g., feeds) to be automatically triggered to maximize cells’ metabolic rate. That produces healthier cells that can provide higher product titers, minimizing process risk and leading to consistent and repeatable product quality. The service provides for real-time, on-line, automated process parameter control and optimization, providing many valuable benefits in bioprocess development and competitive advantage for client companies. Critically important benefits include faster process development, more robust processes with less inherent risk, higher product titers realized earlier in development, healthier cells producing consistent product, an effective increase in otherwise limited process development capacity, and a lowered cost of goods (CoG) overall.
The Ranger service facilitates development of upstream processes that are based on the health and productivity of cells. That represents a significant advance over other approaches to cell culture development that limit the rapid development of optimum processes. Standardized but inflexible process platforms often are used to overcome the lack of real-time analytical and development tools. Such platforms are based on experience but by definition are generic and unoptimized for individual cell lines. Stratophase recognized a market opportunity for Ranger technology and expertise to remove those limitations and provide the industry with more flexible, better-optimized cell culture processes.
At the event, Simon Saxby (chief executive officer for Stratophase) said, “What we found is that the way the industry currently develops its cell culture processes actually doesn’t necessarily offer access to robust processes with quick development timelines. That’s really what we picked up on. So we are offering the ability with a new technology to develop more robust processes more quickly. A lot of the industry was still using techniques that were developed maybe 20–30 years ago, and we saw that there was an opportunity for our technology to change the way that people were operating their processes.”
The Best Technology Application — Downstream Award recognizes a user or supplier of an application that is reducing downstream processing steps and their related time and costs. Strides toward achieving continuous processing regimens and greater efficiencies at later stages (even into formulation, fill, and finish) already are transforming the industry’s ability to work more efficiently. The finalists in this category are companies whose new technologies show, through well-documented applications, that they are indeed game-changers. They were Puridify’s FibroSelect technology and Sanofi’s Accelerated Seamless Antibody Purification (ASAP) approach.
The winner was Pall’s Cadence Acoustic Separator: a scalable, single-use technology for cell culture clarification using acoustophoretic separation. According to Erin Bush (senior manager of global product marketing at Pall Life Sciences), it provides a novel, low-impact method of suspension clarification to separate cells and cell debris from cell culture fluid rapidly and efficiently. Uniquely, the system can provide for scalable continuous clarification when directly linked to primary downstream capture chromatography.
The Cadence Acoustic Separator features five peristaltic pumps that enable four chambers using low-frequency acoustics to generate a three-dimensional standing wave across a flow channel. Cell culture from a fed-batch bioreactor enters the flow channel, and as the cells pass through the 3D standing wave, they are trapped by acoustic forces. Trapped cells migrate to nodes of the standing wave and begin to clump together until their buoyancy decreases and they settle out of suspension. Then the cells can be removed. The technology allows for their continuous removal in a closed system without centrifugation or primary depth filtration, thus streamlining this challenging clarification step in biologics manufacturing within a small operating footprint.
This cutting-edge technology offers diverse advantages and flexible applications for clarification of different types of biologic products — including MAbs and other recombinant therapeutic proteins — regardless of variability in particulate concentrations and cell culture density, turbidity, and viability. It is the only single-use clarification system on the market that enables continuous processing from fed-batch bioreactors. Compared with large-scale depth filtration, the Cadence Acoustic Separator system enables a ~75% reduction of filtration area and associated buffer-volume requirements. The system delivers significant cost savings while reducing tank sizes and overall operational footprint. Process results are highly reproducible, providing clarified fluids with consistent purity profiles.
As Bush explained, “Our team works closely with customers, so we experience their roadblocks firsthand and have recognized the need for a new clarification solution for a long time. The challenge we took on was developing a single-use, continuous cell culture clarification platform that was scalable and versatile in its ability to operate with an ever-increasing range of cell densities. When we first identified this technology, we recognized the great opportunity and moved quickly to begin developing it for biopharmaceutical application.
“We are pleased to report that this crossfunctional platform replaces centrifugation in cell harvest and reduces depth-filtration footprint for a more streamlined process with optimized resource spending. It is game-changing individually and plays a critical enabling role in our recently launched continuous downstream solution — the first of its kind in this industry.”
At the event, Peter Levison (senior marketing director at Pall Life Sciences) said, “There is always the requirement to clarify a cell culture. As we move toward more continuous processes, the Cadence Acoustic Separator enables continuous clarification, an option that centrifugation and depth filtration really don’t address. It also enables the process to be more efficient, more economical, and run in a much smaller footprint. We are looking at alternative approaches — leaner approaches — to reduce waste and make processes more efficient and more economically attractive. This has achieved all of that and is truly innovative.”
The Best Technology Application — Analytical Award recognizes a user or supplier of an analytical-method application. Such work forms the essential foundation of biopharmaceutical and biotherapeutic development at all phases, from preformulation to postmarketing. These methods ensure the consistency and reliability of raw material quality, the safety and efficacy of a drug throughout development and throughout its stages of characterization, consistency of product manufactured in different facilities, worker safety, and comparability to previous lots or of a biosimilar to an innovator product. The finalists in this category have demonstrated increased functionality in novel combinations with other analytical technologies, whether old or new; or they may reveal significant benefit in new applications, including emerging-product sectors. Finalists were Catalent’s BioLayer interferometry application and Ovizio’s iLineF device.
This year’s winner is Sciex’s high-throughput glycosylation analysis. According to Andras Guttman (application manager at Sciex), it is a fully automated sample preparation for ultrafast N-glycosylation analysis of antibody therapeutics. It uses an optimized magnetic-bead–based protocol for endoglycosidase digestion, through optimized fluorophore labeling and clean-up, to ultrafast capillary electrophoresis separation with high-throughput sample processing in a 96-well plate format. Automated liquid-handling processing offered fast and precise sample preparation, reduced flow-induced shear strain on native biological sample matrices, and minimized contamination risks. In this case, fully automated sample preparation means no human intervention is needed from the beginning to end of sample preparation.
This protocol already has been implemented in a number of biopharmaceutical companies. The approach allows for large-scale sample processing to accommodate rapid glycan analysis of therapeutic antibodies. In addition to comparing the glycosylation profile of an innovator drug to its biosimilar counterpart, the biological significance of identified differences also can be addressed. By applying this magnetic-bead–based glycan sample-preparation protocol with a laboratory automation workstation, a large number of samples can be processed in 96-well plates within a couple hours, requiring no centrifugation or vacuum-centrifugation steps.
Demand is growing in the biopharmaceutical industry for high-throughput and large-scale N-glycosylation profiling of therapeutic antibodies at all phases of product development — but especially during clone selection, when hundreds of samples need to be analyzed in a short period to characterize their glycosylation-based biological activity. A novel, fully automatable protocol was necessary. Magnetic beads eliminated the hard-to-automate centrifugation and vacuum-centrifugation steps of currently used protocols.
At the event, Jeff Chapman (global business manager at Sciex) said, “There is a great demand now for higher throughput like oscillation analysis. It’s very critical in evaluating antibody–drug conjugate (ADC) function, for example. In cell culture development, there was a real need to keep high-resolution characterization identification while getting throughput and speed. The real driver was to get more samples ready in a given work day.
“We’ve been working in therapeutic biologic characterization, formulation, quality control (QC), and analytical development. Our teams in analytical development were telling us how they needed much greater throughput. So we were addressing an industry need that was unmet at the time.”
See You In 2018!
Nominations for the 2018 BPI Awards will open in January of that year. It is not too early to begin watching for the people, companies, and technologies that you will want to honor as the best our industry has to offer. Make sure to plan ahead and reserve your spot at the table!
And In Conclusion . . .
Readers of BPI may know Todd Andrews from his work to promote single-use implementation. Todd is the global sales and business development manager for bioprocessing at Colder Products Company.
But Todd also has a thriving career as a stand-up comedian. Following the awards presentations (and with the unenviable position of standing between attendees and icecream and martini bars waiting for them in the corner of the room), he kept everyone laughing at his personal takes on the industry, some good-natured jibes aimed at his colleagues in the room, and the absurdities of life in general. It was a relaxed and entertaining conclusion to a festive evening (www.toddandrews.com).