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With over 45 years’ experience in microbial protein expression, we deliver animal-free, recombinant biological products and technologies to forward-thinking medical device, drug formulation, and drug delivery manufacturers. Working closely together with our customers, we can provide customized biological solutions to make their products safer and more effective while getting them to market faster and hassle free.
Recombinant Human Albumin (rHA)
A range of rHAs (Recombumin
®
, albucult
®
, CellPrime™ rAlbumin AF-S) developed for industrial cell culture and biomedical applications, such as protein drug and vaccine formulation and medical device coating:
Microbially expressed, our rHAs offer the benefits of albumin in a compliant, consistent way and are a convenient replacement to animal and human derived sources.
Bacillus-Based Sodium Hyaluronate
The world’s first sodium hyaluronate produced without the use of animal-derived raw materials or organic solvents:
Produced from the safe bacterial strain
Bacil...
FrieslandCampina Domo, a division of the Ingredients Business Group of Royal FrieslandCampina BV, is one of the operating companies formed as a result of the merger between Friesland Foods and Campina in January 2009 to form Royal FrieslandCampina. Royal FrieslandCampina is a leading global multinational company, with 22,000 employees and revenues of over 9 billion Euros.
Formerly Known As DMV International
The operating company FrieslandCampina Domo incorporates parts of the companies formerly known as DMV International Nutritionals and Friesland Foods domo. These entities have more than 75 years of experience in ingredient discovery, innovation, development, and marketing.
With a new name and enhanced capabilities, FrieslandCampina domo is expanding its presence in the global market. In addition to its global research and development and production facilities, the company recently opened new commercial headquarters for the Americas in northern New Jersey.
Quality, Productivity, Consistency, And Reliabil...
Biopharmaceutical manufacturers are under increasing pressure to improve efficiency while maintaining consistent quality and supply of raw materials. SAFC has supplied the top 20 global biopharmaceutical companies for 30 years with custom-made solutions to complex challenges in the manufacture of monoclonal antibodies, recombinant proteins and vaccines.
SAFC simplifies the complex task of supplying critical raw materials for your process with worldwide distribution channels and warehousing to ensure inventory where and when you need it. Packaging, testing, and labeling are customized to customer requirements. integrated supplier solutions provide expertise in liquid and powder handling and filtration to offer the most robust, comprehensive solutions and services to meet market demands: upstream and downstream reagents for commercial biologics and vaccines; serum-free, animal component–free and chemically defined media, feeds, and supplements; single- and multicomponent dry powder and liquid product formul...
In an effort to mitigate potential risks associated with the introduction of adventitious agents from animal-derived media components, the biopharmaceutical industry has largely shifted to serum-free and/or chemically defined media in cell culture production systems. Successful serum-free media formulations have been developed using plant-derived protein hydrolysates in combination with recombinant supplements such as insulin, transferrin, and human serum albumin, produced in nonanimal systems.
The performance benefit provided by any medium supplement is subject to its interaction with other medium components present in the basal formulation, as well as any additional supplements being employed. In some instances, a combination of supplements may provide better performance than is seen when supplementing with the individual entities. Here we demonstrate such a synergistic reaction between a wheat hydrolysate and recombinant human serum albumin used to supplement a chemically defined growth medium for SP2/...
For more than 30 years, AAIPharma Services has provided drug product development services to pharmaceutical, biotechnology, and medical device companies around the world. Our team of 400+pharmaceutical scientists and professionals, including 20 PhDs, pride themselves on providing solutions to the most difficult drug development and manufacturing challenges. We have developed drugs in all major therapeutic areas, have had our work included in over 500 INDs, and currently provide services in support of more than 50 NDAs/ANDAs. No matter how large or small your company, we can tailor a development program to fit your specific needs.
Lab Services
The goal of our Analytical and Formulation Development teams is to act as an extension of your team and in partnership, effectively develop your molecules into viable clinical and ultimately, commercial drug products. We have over 30 years of experience in providing analytical and formulation development support for drug product development and manufacturing programs...
Althea is a contract developer and manufacturer of biopharmaceutical and injectable products, with fully integrated product development and cGMP manufacturing expertise to support client projects from preclinical development through commercial supply. Each project program at Althea is tailored to the specific needs of your product, allowing you to leverage our entire integrated manufacturing approach, or just the parts you need. While realizing all of the tangible benefits of consolidating your development and manufacturing steps, you’ll also have the confidence of knowing that your product is being championed by seasoned professionals that boast an impressive track record of more than 150 cGMP lots of bulk drug substance and more than 750 cGMP lots of final product delivered-to-date.
Biologics Manufacturing — Recombinant Protein and Plasmid:
Whether it is protein or plasmid production, Althea’s experienced staff can take your microbial-expressed product from cell banking to final formulation. As you adv...
Biotech companies appreciate the challenges involved in raising sufficient investment to support their drug development pipelines. In today’s economic conditions, it is even more critical that burn rates are minimised along with risks to achieving major product development and clinical milestones.
Having reached the preclinical stage, the strategic decision whether to build in-house capability or outsource biopharmaceutical manufacturing will have been made. Limitations with investment is the main factor that will direct most companies to seek the services of a CMO (contract manufacturing organisation), and this decision should be informed by many factors including the appropriate regulatory licenses, technical know-how, track record of delivery, effective project management, and a team clearly committed to success.
About Angel Biotechnology
Angel is a UK-based CMO whose partnering approach to working with customers addresses the classic issues that face companies outsourcing manufacturing. Established in...
Avid Bioservices offers a fresh approach to the Contract Manufacturing organization (CMO)–client relationship: fully integrated services across the process chain, including cell line and process development, analytical methods development, cGMP manufacturing, fill/finish, regulatory submission, and commercialization of biologic drug product or drug substance. our expertise enables our clients to succeed in their ventures.
As a wholly owned subsidiary of Peregrine Pharmaceuticals, a clinical-stage biotech company with a management team experienced in the commercialization of therapeutic proteins, we know what it takes to navigate our clients’ biologic from concept to commercialization. This allows us to provide our clients with unique insights to manage the challenges of drug development and commercialization while mitigating risk, reducing costs and accelerating time to market.
Capable of Meeting Market DeMand
At Avid, we strive to be the partner of choice by providing a more comprehensive approach to con...
As the demand for plasmid DNA (pDNA)–based gene therapy and vaccines increases, large-scale, cost-effective, and reproducible pDNA production will be required. The key to success is a real-time, in-process control method that ensures a high percentage of supercoiled pDNA in the final product. CIMac pDNA Analytical Column allows the monitoring of degradation products (open circular and linear pDNA), the removal of impurities (RNA), and the assurance that each production step is yielding the amount of supercoiled pDNA anticipated.
Figure 1: ()
An example of a pDNA purification processs (Figure 1) based on our CIM HIP
2
Plasmid Process Pack (for details please check the product brochure or visit our website) with in-process control steps is shown in Figure 3. The final product composition is confirmed by agarose gel electrophoresis (Figure 2). In Figure 4, the complete separation of all three pDNA conformations from a test solution within 10 minutes on the CIMac pDNA Analytical Column (Figure 2) shows the v...
+1
Mycoplasma contamination of cell culture (both of primary and continuous eukaryotic cell lines) is common and represents a significant issue of importance in the basic research, development, and production of biologicals. Contamination can alter virtually every physical and chemical property of cells (depending on the contaminating species and the cell type), potentially leading to unreliable results and perhaps unsafe biologicals, biopharmaceutical drugs, or viral vaccines. In fact, contamination may be present with no obvious change in the host culture, even when the concentration of Mycoplasma exceeds that of the host cells by 10- to 100-fold. Thus, testing for Mycoplasma contamination during development and manufacturing is a requirement by the worldwide regulatory authorities in the United States, Europe, and Japan. Key regulations are defined under
European Pharmacopoeia
(EP) section 2.6.7 (
1
),
Japanese Pharmacopoeia
(JP) section 9 (
2
), FDAPoints to Consider (PTC) documents in 1993 (
3
) and...
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The standard cell line development pathway at many contract service organizations is based solely on selecting clones by growth and productivity with little or no analytical characterization of the expressed protein. The use of protein analytics to support selection of clones that match desired product quality is important for second-generation processes and will be of utmost importance for biosimilar development. CMC Biologics performs sophisticated protein characterization using state-of-the-art analytical equipment combined with our robust cell line development platform to generate and identify production- quality clones with desired product quality attributes in very rapid timeframes.
Implementing protein analysis into the cell line development process requires a robust platform capable of producing consistent results and timeframes. More importantly, it requires flexibility to enable matching of specific product quality attributes in the midst of the ongoing clone selection process. CMC Biologics’ CH...
Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its comprehensive portfolio of services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
Working with clients of all sizes, Covance recognizes that your development program is as unique as the product you bring to our facilities. With over 250 different biomolecules successfully supported annually, Covance Biopharmaceutical Services provide you with a global, multidisciplinary team of experts and specialized state-of-the-art infrastructure to help achieve your development and commercialization goals.
The comprehensive Covance biopharmaceutical service capabilities include extensive expertise and experience in:
Covance has a complementary portfolio of discovery, nonclinical safety assessment, clinical development, periapproval, and market access capabilities for full development ...
byJi Wu
Diosynth Biotechnology, based in Research Triangle Park, NC (USA) and MSD Biologics (formerly Avecia Biologics) based in Billingham, UK have combined to form the BioManufacturing Network. Together the two organizations offer industry-leading CGMP contract manufacturing services for recombinant proteins, vaccines, and monoclonal antibodies with an attractive geographical footprint in the USA and Europe. Our combined expertise enables our customers to improve the cost-effectiveness of new therapies by providing fast-track progress into and through their clinical development program, process validation, commercialization, and supply.
Proven Track Record
Our track record in delivering successful programs will provide manufacturing support as your product reaches its next clinical stage quickly, economically, and on time. Our experience includes:
Process Development and Scale-Up
Our experience ensures process development is applied appropriately, dependent upon the development needs of customer products at dif...
This year marks the 10-year anniversary of Eden Biodesign, so we thought it fitting to reflect on our past and look to the future as we remain committed to growth, success, and our long-standing reputation for being much more than a CMO. Eden has grown from a single- roomed office to a multinational organization with locations in the United States and Europe as well as partner organizations around the globe. We operate a custom-designed, 41,000 ft
2
MHRA-licensed multitechnology and multiproduct cGMP biomanufacturing center in Liverpool, UK, which now employs ~90 people and is poised for a new round of expansion.
In January 2010, Eden Biodesign was acquired, and it is now a wholly owned subsidiary of Watson Pharmaceuticals, Inc. (NYSE: WPI). Watson is a global specialty pharmaceutical company with £3 billion in revenues, a broad product line, and operations in well established and emerging markets. This provides Eden and our customers with extremely strong security as we continue to be dedicated to provi...
Figure 1: ()
Selection of a CMO is critical to biologic drug development; and the primary selection criterion is experience. How do biotech companies measure experience? CMO experience can be measured in many ways — primary metrics include (1) total number of GMP processes developed by a CMO; (2) number of projects involving your strain; (3) number of projects involving your product type; (4) GMP production success rate; (5) total number of GMP lots produced; and (6) number of quality audits.”
Eurogentec’s biologics division is specialized in the manufacturing of biopharmaceuticals from microbial sources: bacteria, yeast, and biosafety level 2 (BSl-2) organisms. Eurogentec has manufactured according to GMP since 1994.
Figure 1: ()
Figure 2: ()
Figure 3: ()
Host Cell Experience: Microbial Experts
Eurogentec has expertise with
E. coli, P. pastoris, H. polymorpha, S. cerevisiae
, and numerous BSl-2 organisms.
Chemistry Experience: Conjugation Experts
Product Family Experience
GMp Infrastructure
Process Deve...
The goal:
Develop a CGMP formulation–fill process for a subunit vaccine–aluminum adjuvant complex.
The challenge: T
o engineer a scaled-up process for vaccine–adjuvant suspension formulation and fill, ensuring a uniform fill per dose as well as a sterile product.
The outcome:
Florida Biologix scientists successfully developed the manufacturing, formulation–fill process and test methods. The process was conducted successfully in a scaled-down engineering run and at full scale, and 2,500 vials were tested, released, and shipped to the clinic on time.
About Florida Biologix
Aseptic fill is only one small part of our business. Florida Biologix is a phase 1–2 biologics development, manufacturing, and testing organization that offers a wide range of services to the biotechnology industry. FB will overcome scientific challenges with scalable solutions for phase 1–2 and beyond; provide exceptional customer service with clear and honest communication; and ensure client manufacturing process ownership of high-qua...
The FDA has been focusing effort into evaluation of potential adulteration of drug products due to contact with packaging and closure systems, sample delivery devices, and components used in product manufacturing. Packaging includes components such as vials, caps, and stoppers. Drug delivery devices include nebulizers and inhalers. Components used during product manufacturing include filters, tubing, fittings, connectors, bioprocess bags, and bioreactors. Lancaster laboratories provides support by performing extractables and leachables testing. Extractables are compounds that can be extracted from a component under extreme conditions such as the presence of harsh solvents or elevated temperatures. Leachables are compounds that leach into drug products from a component through direct contact under normal storage or manufacturing conditions. Both extractables and leachables represent possible drug product contaminants and therefore need to be evaluated.
Sources
of extractable and leachable compounds includ...
RecipharmCobra Biologics is the specialist biologics division of the Recipharm AB group, one of the leading contract development and manufacturing organisations in Europe. We provide a comprehensive range of services, from early-stage development to the supply of GMP material for Phase I, II, and III clinical trials. We are with you every step of the way.
The Market Is Growing — So Are We
We have provided contract development and manufacturing services to customers worldwide for more than a decade, and now Recipharm has expanded its biologics capabilities to include two development and GMP facilities in Södertälje, Sweden and Keele, UK. With this expansion of capacity and expertise, we are able to offer extensive services to the growing biopharmaceutical market.
One-Stop Shopping or Stand-Alone Services
RecipharmCobra’s services include cell line development, analytical and process development, and GMP production for recombinant proteins, monoclonal antibodies, DNA, viruses, and cell products. This, with ...
With Richter-Helm BioLogics and Richter-Helm BioTec, over 20 years of experience in development and manufacturing of biopharmaceuticals and the innovative strength of high-performance teams are coupled with the solid foundation of the owner companies Gedeon Richter Plc. (Hungary) and HELM AG (Germany).
Preclinical to Commercial Supply
Richter-Helm BioLogics offers services for development and manufacturing of biopharmaceutical products from customers in the pharmaceutical and biotechnology industries. Richter-Helm BioLogics develops and produces recombinant proteins, plasmid DNA, and vaccines in microbial systems. Richter-Helm BioTec is responsible for business development, marketing, and sales activities as well as the management of product developments — not only for their own pipeline, but also for joint project development work in collaboration with associate companies. To enlarge the product pipeline, Richter-Helm BioTec is actively seeking for further development projects at all stages. Richter-Helm...
Applications of microbial fermentation technology in new therapeutics are expanding. SAFC offers unique cGMP fermentation-based manufacturing capabilities through its Jerusalem facility, including highly potent APIs and biologics. SAFC scientific teams provide a complete range of services, including process evaluation and development, optimization and scale up, technology transfer, manufacturing, analytical testing and regulatory filing to help customers bring new drugs to market faster.
SAFC is finding new applications for its expertise in fermentation technology, including the synthesis of high potency active pharmaceutical ingredients (HPAPIs) and therapeutics. These applications draw on the use of microbial biofactories, which offer the pharmaceutical industry a diverse, reliable, powerful, and economic source for therapeutics, many of which are primarily isolated through microbial fermentation.
Chemical Therapeutics
Toxic, small, organic molecules produced naturally by microorganisms in response to s...
Sandoz is one of the leading specialists in microbial fermentation of classic and recombinant microorganisms. The company’s comprehensive know-how is based on more than six decades of experience in the field of classical microbial products and more than two decades in recombinant microbial production at commercial scale. Building on this know-how, Sandoz offers a broad variety of integrated services including innovative expression systems, process development, scale up and production of recombinant products derived from microbial systems, and mammalian cell culture in state-of-the-art facilities.
Our expertise is based on numerous projects successfully performed in collaboration with our customers. Currently, Sandoz is manufacturing more than 25 different recombinant products for well-known pharmaceutical and biotechnology companies located in the United States, Europe, and Japan. Our FDA-approved facilities fulfill worldwide quality requirements.
Services Offered
Production of Recombinant Peptides and Pr...
Vetter, a leading provider of aseptically prefilled drug delivery systems, is poised to launch a new state-of- the-art facility at the Illinois Science + Technology Park in suburban Chicago. An expansion of Vetter Development Service, the Chicago site will support preclinical through phase II development projects. The 24,000-ft
2
facility includes three cleanrooms, microbiology and chemical laboratories, and administrative offices.
Early-Phase Work
Developed at the urging of Vetter’s North American clients, the Chicago site, like Vetter’s European facilities, will support small- batch, early-stage products. Biotechnology drugs, in particular, are highly sensitive complex compounds. Vetter has extensive experience working with such substances, including monoclonal antibodies, peptides, interferons, and vaccines. Type of stopper or glass and degree of siliconization can potentially interact with a product’s active ingredient. Matching drug product to delivery system and manufacturing process is critical. S...
Conclusion
The removal of DNA from cell culture broths and lysates may be required to accomplish the CBER-recommended concentration of DNA impurity of
About the Author
Author Details
Michael Wang, PhD,
is a Marketing Manager Bioprocess at 3M Purification Inc., 400 Research Parkway Meriden, CT 06450-1018; 203- 238-8795;
[email protected]
.
1.) Dorsey, J. 1997. The Role of Charge in the Retention of DNA By Charged Cellulose-Based Depth Filters. BioPharm 10:46-49.
2.)3MPI Application Brief: DNA Removal from Bioprocess Purification Processes.
Increased productivity and reduced costs continue to be the driving forces in process development. Recent advances in upstream processes have dramatically improved the productivity of cell culture fermentation. However, prolonged fermentation and high concentration of monoclonal antibodies (MAbs) at harvest may also lead to product degradation and/or aggregation. Clearing these unwanted by-products remains one of the main challenges in downstream processing of therapeutic MAbs.
Media with high binding capacity for target molecules and significant resolution power for impurity clearance are in great demand. Nuvia S — a high-capacity, strong cation exchanger (CEX) built on the industry-proven UNOsphere™ technology — is designed to meet these needs of modern downstream processing.
Flow Properties and Dynamic Characteristics of Nuvia S Media
All UNOsphere-based chromatography media are characterized by their excellent flow properties and fast mass transfer. Nuvia S continues this tradition. The surface extend...
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A clear mandate has emerged throughout the industry to improve the timelines from candidate identification to phase 1 clinical trials. The goal of reducing the time to phase 1, combined with increasing titers and regulatory requirements, presents novel challenges to downstream development. To meet these challenges, Boehringer Ingelheim has developed the BI-Purification Excellence (BI-PurEx) strategy to shorten the development time to clinical trials while improving process understanding during early development phases to ensure a safe, effective, and competitive process for each novel therapeutic protein. BI-PurEx is an innovative downstream development strategy that maximizes efficiency and flexibility to specifically focus on the most critical aspects of each project. Through the development and application of this modular and flexible technology platform, Boehringer Ingelheim can deliver a robust, efficient, and scalable process with significant process understanding within the timeline of a platform p...
Over the past decade the adoption of single-use technologies has moved beyond upstream processes to bulk and filling applications. One example of integrating single-use systems in a final fill operation is to simplify connections to mobile stainless steel transfer tanks. These tanks are designed to transfer product from formulation suites to storage areas and ultimately to filling suites. To allow sterile connection to and from these vessels, designers traditionally add three-way valve assemblies to fill and drain ports to facilitate SIP operations, but the design of these valve assemblies makes it difficult to validate cleaning procedures. Replacing these heavy assemblies with single-use tube sets and connectors will eliminate cleaning validation and maintenance.
Single-use tubing assemblies can either be attached to the mobile tanks prior to equipment sterilization with single-use SIP connectors, or steamed separately, just prior to fluid transfer. For vessel outlet, combining a number of single-use com...
Eshmuno™ is a new and unique family of ion-exchange resins that are designed specifically for highly productive downstream bioprocessing. The first member of the family, Eshmuno™ S, is a smart cation exchanger designed for fast and efficient purification of antibodies in direct capture and steps following protein A chromatography. Eshmuno™ Q is the newest family member. This smart anion-exchange resin coupled Merck KGaA’s renowned tentacle structure with the new hydrophilic polyvinyl ether base matrix. As a result, Eshmuno™ Q offers outstanding results in typical anion-exchange applications, such as removing impurities in flow-through mode or separating blood factors in plasma processing.
Superior Productivity for Biomolecule Purification
Eshmuno™ Q exhibits a superior binding capacity for various biomolecules. Figure 1 shows the dynamic binding capacity (DBC) of Eshmuno™ Q for selected macromolecules at different flow rates. High flow rates (2 minutes residence time correspond to ~600 cm/hour) do not aff...
Today’s antibodies are sourced from a diverse set of mammalian hosts whose isotypes have different affinities for protein A and protein G. ForteBio’s new protein G biosensor provides an “out-of-the-box” solution for direct quantitation of the mammalian immunoglobulins that do not bind to protein A. Readings can be performed in buffer, chromatography eluents, conditioned medium, and cultured lysates using a convenient 96- or 384- well microplate format. Assay parameters can be adjusted to detect concentrations from 0.05 µg/ml to 2,000 µg/mL, and the biosensor can be regenerated using a simple protocol. Turn around 96 samples in 15 minutes, 384 samples in one hour. No plate washing, no microfluidics, no liquid waste.
Key applications of the protein G biosensor:
cell line development clone selection; upstream process development; chromatography mass balance; antibody affinity ranking; epitope mapping and binning; selection of ELISA antibody pairs.
Key features of the Octet system:
direct, label-free, prote...
Summary
Comparison of a complete MAb purification process from a 100-L cell culture volume demonstrated a 50% reduction in process time using the ReadyToProcess platform instead of traditional process equipment. The decrease was made possible by elimination of column packing and testing, membrane wetting and rinsing, system cleaning, cleaning validation, and so on. Additionally, the ReadyToProcess run required less hardware and thus generated a smaller footprint. Both chromatography steps were run on one system using disposable, exchangeable flow paths. There was no difference in quality between the traditional process and the single-use process. However, using ready-to-use equipment instead of traditional process equipment contributed to increased productivity and process safety.
About the Author
Author Details
Kajsa Bringle,
MSc, is marketing leader for ReadyToProcess at GE Healthcare Bio-Sciences AB, Björkgatan 30, 75184 Uppsala, Sweden,
[email protected]
; www.gelifesciences.com/readytoprocess.
Influenza virus vaccines have traditionally been produced by infection of fertilized hen eggs. This labor-intensive approach requires large facilities, which has led to the development of large-scale mammalian cell culture methods for future virus vaccine production processes.
The main focus of these studies was to use generic, established, and scalable techniques for industrial production of live influenza vaccines (Figure 1) and potentially also for other viruses independent of type or size. Development of three different focus areas in live influenza processing are described: Optimization of a disposable cell culture step; a downstream purification process for efficient removal of genomic DNA (gDNA) from live influenza virus cultured in Madine-Darby Canine Kidney (MDCK) cells; and development of a fast, accurate live influenza assay.
Figure 1: ()
Cell Culture Development
WAVE Bioreactor systems were originally designed for culturing cells in suspension. However, several cell types used for cell therapy...
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