From the Editors: BioProcess International Conference 2014 Producer Preview

Now in its 11th year, the BioProcess International Conference and Exhibition is the industry’s number-one event. At BPI you can make new connections in the field while strengthening current relationships. Network with the advisory committee and speakers, meet key industry contacts, share new ideas with poster presenters, and discover new technologies from exhibitors and sponsors. Participate in interactive sessions and discussions. This year’s program offers multiple new formats for sharing information and ideas.

Networking: Join the partnering360 online network for access to a year-round knowledge exchange and life-science community. Once registered, you get additional access to an event-specific networking tool for scheduling meetings with potential partners before, during and following this event. At the conference, you can choose from 63 case studies and 65 new-data presentations by industry experts and thought leaders, 85% of whom are new to this year’s program.

The Producers Speak

BPI’s marketing and digital content strategist, Leah Rosin, spoke with IBC’s Barry Walsh and Michael Keenan, the directors of the BPI Conference. They have conducted research with all sizes of companies and a range of departments to determine the educational needs of the biopharmaceutical industry. That research has helped them develop a conference program that provides practical knowledge while encouraging innovation.

Barry, can you tell us what is different about this year’s conference? On the first day of the event we have incorporated a full day of content devoted to cell therapy bioprocessing, which will help companies develop scalable processes and hopefully help them achieve commercial success. With the increased focus on raw materials, we have also developed a discussion centered upon “How Well Do You Know the Raw Materials for Your Upstream Manufacturing Process?” The panel will discuss what information from cell culture media suppliers is “nice to have” and what’s a “need-to-have,” along with some challenges that suppliers face in providing a requested level of information.

We have also added the BPI Theater to the Exhibit Hall, featuring a host of interactive activities and information-packed content. This is designed to provide attendees with industry-critical information in multiple different formats. Attendees will have numerous opportunities to interact with and learn from conference speakers, industry experts, and even other attendees there.

A new session added to the recovery and purification track will focus on exciting innovations taking place in material science. These include the use of new polymers, fibers, and hydrogel membranes to develop the next generation of purification platforms and processes. Another new session in that track will focus on the application of in-silico mechanistic modeling to improve process understanding and help companies develop more efficient purification processes.

As part of the cell culture track, we will look at the harvest-step interface. We’ve developed a new session that covers the integration of disruptive technologies such as acoustic-wave technology and disposable depth filtration.

We are also proud to introduce “partnering360,” which is an online tool designed to help attendees schedule meetings and foster deeper engagement with their peers before, during, and after the event.

Michael, do you have anything to add? I’m pretty excited about some of the interactive sessions we have planned for the meeting this year. There will be a point–counterpoint discussion on evaluating the challenges and considerations of environmental controls. As pharmaceutical facilities become more flexible, there is a real push in the industry to relax the rigid environmental controls required by the US Food and Drug Administration (FDA).

We’ve added a session this year focused on early stage companies and those with early stage molecules in development. We’re trying to bridge that gap between discovery and development, so companies can learn strategies to move quickly to the investigational new drug (IND) stage and beyond. What are the success factors for early stage biologics developers who want to make that transition quickly?

I’m also pretty excited to have the BioPhorum Operations Group (BPOG) represented at this year’s meeting. BPOG representatives will share updates from four strategic work streams with which they are involved: on the single-use systems supply chain, on raw material variability reduction, on continued process verification, and on bioburden control strategies. BPOG is an organization of industry companies who come together to share best practices. So I’m very excited about that session, as well.

Also this year, we have an interactive town-hall forum on standardization of single-use systems with a number of additional respected industry consortia included: the American Society of Mechanical Engineers (ASME), the American Society of Testing and Materials (ASTM), the Bio Process Systems Alliance (BPSA), the Parenteral Drug Association (PDA), and the United States Pharmacopeia (USP). They are coming together to talk about the next steps for the industry in terms of standardizing single-use technologies. These are technologies that have been widely deployed throughout the field. They are significantly affecting process development and manufacturing and improving flexibility. This interactive forum will be an opportunity for the audience and the consortia to discuss where we need to move forward to get single-use systems and components deployed even more throughout the industry.

Barry, can you tell us why the conference has included a focus on cell therapies and antibody–drug conjugates (ADCs)? What will the speakers will be sharing? Sure. The field of cell therapy is quickly moving from laboratory to industry, and companies developing these therapies need to learn how to apply the latest scientific and technical innovations to develop scalable and commercially viable manufacturing processes. Presentations during this full-day symposium will cover process and product development; chemistry, manufacturing, and controls (CMC) in product characterization approaches; and scale-up, manufacturing, and commercial strategies.

Many new and exciting technologies are being used to advance the development of ADCs. So we have devoted a full-day symposium to cover the next wave in their development, which will greatly increase the therapeutic windows of these antibody-based therapeutics. The symposium will begin with development of homogeneous ADCs, site-specific approaches, risk mitigation strategies, and novel linkers and warheads for improved efficacy and stability. The second half of that symposium will cover scale-up approaches in ADC manufacturing, as well as outsourcing components of ADC development in production.

Continuous bioprocessing is also a big theme this year, and it was at the BPI Europe Conference too. Barry, how will your speakers address this topic? We have devoted a half-day session that will bring together the cell culture, manufacturing, and recovery and purification track attendees to hear how companies are developing continuous upstream processes, continuous downstream processes, and fully integrated disposable continuous processes.

Quality risk management (QRM) is also a big issue, with analytics being at its core in supporting risk management. Michael, what do you hear from end users about QRM, and which speakers will be addressing this area? One thing we hear from companies is that QRM is one of the biggest issues for which they are trying to figure out strategies. Quality is ultimately the thing that everyone is looking for in biologic products, and it’s what regulators are looking for too. So companies really have to have a QRM strategy that addresses these issues throughout their products’ life cycles.

In the analytical and quality track at BPI this year, a couple of key sessions cover quality considerations in bioprocess development and manufacturing and one session focuses specifically on QRM and analytics. Speakers will be discussing topics such as how to apply quality-by-design concepts to legacy products. We have an interesting talk from GlaxoSmithKline on microbial control (“What’s Bugging You?”). Companies need quality systems to deal with microbes and viruses and pevent contamination of their products.

We’ve also got an exciting talk from Merck on how to increase efficiencies by moving analytics to the manufacturing floor. That’s talking about quality manufacturing and how analytics plays a role in that. The quality session should be compelling this year.

Formulation innovation for next-generation complex molecules is a focus of Thursday’s formulation track. Mike, what can audience members expect to take away from those talks? A lot of exciting and different new molecules are being developed in the industry right now: from ADCs to fusion proteins and next-generation molecules. The formulation and delivery track this year covers process development strategies for such complex molecules. Attendees can expect to hear about innovative technologies and phase-appropriate strategies for formulation development and delivery of MAbs, next-generation biologics, non-MAb proteins, vaccines and a range of modalities. We’ll be looking at things such as high-throughput methods, preformulation and liability assessments, stability testing, and physicochemical characterization strategies. Speakers from companies developing some more complex molecules will present case studies involving formulation tools and strategies those companies are using to move their products along.

Can you talk about the “Knowledge Management Symposium?” What is that, Mike? Basically, the crux of it is how to take all of this information we’re collecting from all of our scientific programs and unit operations and turn those data into knowledge that we can use to make our products better. A preconference symposium on knowledge management across the product and process life cycle will talk about some methods and tools that organizations are using. Companies such as Takeda and Roche are really ahead of the curve in putting together state-of-the-art information management systems that help them harness all those bioprocess data and turn them into knowledge for decision making.

Then we’re going to have a session focused on true applications in biopharmaceutical development. Merck will present a case study of how it applies knowledge management techniques to the next iteration of molecules in development. Genentech has a cutting edge knowledge-management solution that is helping to answer many questions so the company can make better decisions. Amgen will talk about how it applies knowledge management for operational excellence. We’ll also have presentations on knowledge management as applied to the raw material supply chain, which is a really big area as companies try to make that supply chain more transparent.

Finally, knowledge management can be applied to continuous process verification and continuous improvement. Companies such as Genzyme and Pfizer will be talking about how they apply it to help meet the needs of the process validation guidance that recently came out from the FDA. That will be followed by a panel discussion. That is a new session this year.

Can you tell us about the two-day training courses, Mike? How do they work as far as conference registration and colocation? And who are they directed to as far as audience? We have four two-day training courses this year. One provides an introduction to biopharmaceutical manufacturing, a second course focuses on CMC analytical comparability and stability studies, a third discusses practical technology transfer methods for biopharmaceuticals, and the fourth is on QRM across the biopharmaceutical life cycle.

With the training courses at BPI, you get the best of both worlds because you can take a two-day training course plus a two-day conference pass to attend the four days of the conference as well. The courses are for a range of people. First, it could be those who are new to the field trying to get an overview of a particular area of focus in bioprocess development and manufacturing. Also, let’s say you are a manufacturing scientist and quality issues impact your job. So you want to learn about QRM. These courses could help cross-fertilize ideas between departments. They’re often geared for senior-level managers to get an overview of different areas in bioprocess development and manufacturing. I think the courses can provide what you need, whether that is an in-depth focus or an overview. I think there is something for everyone.

Are there any other activities that you would want the audience to know about, Mike? There is really a lot going on this year. There is a site visit to the Pall Life Sciences facility in Westborough, MA, on Monday, 20 October.

We are expecting more than 100 scientific posters for the dedicated poster-viewing hours and oral poster presentations, which presents a great opportunity for attendees to network with other scientists and share research. And our huge exhibit hall will have more than 150 exhibitors, offering an opportunity to network with pretty much every major bioprocess solution provider in the industry.

We have a number of themed network receptions planned, as well. The kick-off reception is sponsored by 3M on Monday night. We’ve got another reception on Tuesday night and an international food festival at the grand opening of the exhibit hall, which will include a lot of activities and networking with fun, food, and drinks. And there’s a reception on Wednesday, as well — so a lot of networking, receptions, and cocktails planned.

Barry mentioned the BPI Theater, which will include live interviews and new product demos. And of course, the BPI International Awards will take place during the BPI Conference this year, as well. That’s a lot of exciting activities to go along with the >160 speakers we have at the meeting this year.

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