Genetic Engineering & Biotechnology News

JAN15 2018

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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18 | JANUARY 15, 2018 | | Genetic Engineering & Biotechnology News Fortunately, speed-enhancing technologies are available, and they may be implemented up and down the vaccine pro- duction line. Vaccine manufacturers that recognize the "need for speed" are: • Elaborating on core molecules to build vaccines of different types, allowing the use of simplified manufacturing platforms. • Deploying diverse vectors, transfection systems, and host cells to develop highly productive expression platforms. • Using vaccine-like particles (VLPs) to support plug-and- play antigen-presentation platforms. • Switching to single-use technologies to reduce downtime between batches, even if the batches consist of different products. • Incorporating prefabricated and modular units to reconfigure or expand production facilities. All these developments have a common theme: the stream- lining of operations that might otherwise become unwieldy because vaccines need to incorporate more—and more varied—biomolecules. Although higher mo- lecular diversity increases vaccine production com- plexity, such diversity can be managed. The management of diversity will be discussed by the vaccine industry's leaders at the next World Vaccine Congress, which will take place April 3–5, 2018 in Washington, DC. Whether they are slated to present papers or run exhib- its on the show floor, these vaccine development and manufacturing experts are prepared to dis- cuss the current state of the industry and its in- novation-driven future. For a preview of the insights these experts intend to share, continue reading this GEN article. Transfection Gets a Jolt According to James Brady, Ph.D., vice president, Tech- nical Applications and Customer Support, MaxCyte, flow electroporation technology can transfect up to 2 × 10 11 cells in less than 30 minutes, obviating the time-consuming and labor-intensive steps associated with making producer cell lines. A wide range of vaccine formats can be produced in multiple adherent and suspension-adapted cell lines. Flow electroporation is scalable (from 0.5 × 10 6 to 2 × 10 11 cells per transfection run); has high transfection efficien- cy with multiple cell lines and loading agents; and is compat- ible with a wide range of culture formats and production systems. The system is cGMP compliant and supported by an FDA device master file. As with all transient expression methodologies, sufficient quantities of loading agent—typically plasmid DNA or mes- senger RNA, specific to individual vaccine formats—must be prepared. Many commercial vendors supply loading agents at the scales and specifications required for GMP produc- tion. In addition, multiple technologies are available to ad- dress the large-scale cell-processing challenges, which are not unique to flow electroporation. MaxCyte's flow electroporation technology has been vali- dated for a wide range of cell-engineering applications. It is being used to manufacture commercial cell therapy products, as well as to develop viral-vector and VLP vaccine candi- dates. The latter applications are being pursued by several commercial and governmental entities. Single-Use Solutions in Manufacturing In the past big, bulky, inflexible stainless-steel bioreactors with companion stainless-steel connections were used. Each component required washing, sanitizing, and qualification before use for a new batch or product. This costly endeavor involved considerable effort and time, and contamination was always a possibility. "Nowadays, specialized bags go into the bioreactors and the connections are plastic tubing; everything is single use, reducing human error and contami- nation, upfront capital investment, and water usage," says Daria Donati, Ph.D., director of business development and innovation, Enterprise Solutions, GE Healthcare Life Sciences. "Single- use solutions in manufacturing make it simpler to pass from one product or one batch to another." Single-use technologies are integral to GE Healthcare's FlexFactory systems (Figure 1). "These manufacturing platforms can be deployed—assem- bled, validated, and qualified—in less than one year where needed," says Dr. Donati. "Plus, our KUBio turnkey modular facilities reduce the time and risk needed to build facilities. KUBio facilities are available for monoclonal anti- body production and are currently being developed for vac- cine production." KUBio facilities include everything that is needed—from the facility itself to the process equipment for biopharma- ceutical manufacture—and they can be delivered in less than half the time it takes to build a typical facility. On-site modu- lar facilities can be assembled rapidly, within eight days of arrival at the site. A Fast Trak team provides the customer with specific training on production and troubleshooting. This bridging ser- vice can also produce clinical material for toxicology studies, as well as for Phase I and Phase II trials, while the factory is being set-up. In addition, the analytical platform, Biacore sur- face plasmon resonance (SPR) technology (GE Healthcare), supports quality, toxicity, and potency testing. It can be used in both vaccine and biomolecule research and manufacture. Insect Cell Platforms ExpreS2ion Biotechnologies has developed ExpreS2, a Vaccine Industry Retools Itself for Speed Bioprocessing Feature Figure 1. FlexFactory facilities are assembled, validated, and qualified manufacturing platforms based on single- use technologies that can be quickly deployed in less than one year where needed. GE Healthcare Life Sciences Mary Ann Labant Pathogens evolve and epitopes shift at an alarming rate, threatening to outpace the vaccine industry, which struggles to keep up, even though it has already started to upgrade its manufacturing technology. The vaccine industry needs to consolidate diverse technological advances if it is to truly hit its stride and respond to fast-emerging dangers such as Ebola and Zika. [New platforms are streamlining] operations that might otherwise become unwieldly because vac- cines need to incorporate more— and more varied—biomolecules.

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