Optimization of chemically defined animal-derived component free media to culture mammalian cells and optimization of existing commercial media is possible with their supplementation with specific additives.

MaxCyte flow electroporation is a universal, clinically validated transient transfection platform for rapid, high-quality cell transfection in the development and production of vaccines and cellular immunotherapies.

Recombinant monoclonal antibodies (MAbs) maintain their ranking as the best-selling class of biologic drugs. The introduction of high titer bioprocessing for the majority of these MAb products has focused efforts towards maintaining desired quality attributes and reducing time to market. Furthermore, patents covering several blockbuster MAbs and the expression technologies, which facilitate their high-level expression, are due to expire over the next decade. A wave of second generation or “follow-on” biopharmaceuticals/bioprocesses will therefore be vying for market share and regulatory approval. Consequently, should biopharmaceutical manufacturing companies rely on traditional “platform” methods of cell line development (CLD), which are well known but yield extensive variation and unpredictable stability of expression, or invest in emerging technologies, which offer the potential of greater reproducibility and speed? Enabling technologies in this area include host cell engineering, engineered expression vectors, and rapid transient gene expression. Given the well-known mantra “the product is the process”, implementation of these disruptive technologies will require a thorough understanding of how changes at the CLD-phase affect key production process characteristics such as high cell-specific productivity, correct product processing and rapid cell proliferation. Traditionally, CLD optimisation is carried out using a lengthy trial-and-error approach where cells are treated as a “black box” and characteristics are iteratively improved. Further advancement in CLD is therefore likely to benefit from the tools of systems biology. These tools will ensure that future CLD manipulations will be informed by an understanding of the genetic, regulatory, and metabolic networks that determine key process characteristics during a production process.

Production of biotherapeutics whether for clinical development or large scale manufacturing campaigns intended to be converted to final drug product often involves frozen storage. Frozen storage provides manufacturing process flexibility while enabling long-term product stability. Products are frozen and stored using a variety of technologies including stainless steel vessels, bottles, carboys and single-use bags. Use of bags has become popular due to their low investment cost and process flexibility attributes. Single-use bags intended for freezing and storage are often made with films using EVA and/or LDPE with product routinely blast frozen and stored to -30°C in a cold storage warehouse. During freezing and transport, the bags will typically experience temperatures well below -30°C ranging from -50 to -80°C. Under these conditions, the bags have to endure a wide variety of stresses (film brittleness, volume expansion, etc.) impacting integrity. With applications (like working cell banks for example) requiring lower temperatures for maintenance of long-term product stability, frozen storage films and containers designed for these conditions are needed. The new single-use Freeze-Pak™STS (FP-STS) frozen storage and transport solution containers from Charter Medical, Ltd. are manufactured using a unique polyolefin monolayer film designed for freezing applications The FP-STS bags (including tubing and connectors) have been validated for storage to -80°C, while the Freeze-Pak™ film remains flexible to temperatures as low as -196°C. The new Freeze-Pak™ STS bags deliver the flexibility and durability required for frozen storage and transport.

Single-use bioreactors are usually applied in the biopharmaceutical industry for mammalian cell culture processes. For microbial processes, concepts like the CELL-tainer® technology allow comparable gas-liquid mass transfer rates like in stirred tank reactors. In the CELL-tainer, the rocking motion of the bag is generated with a combination of a vertical and horizontal movement. Due to a 2-D rocking motion, the turbulence in the liquid is intensified. Thus, volumetric oxygen transfer rates (kLa) of over 400 h-1 could be achieved. Recently, the successful scale-up of an Escherichia coli nutrient-limited fed-batch cultivation from the 15 L to the 150 L scale in the CELL-tainer single-use bioreactor has been conducted. A final biomass concentration of 45 gL-1 within 24 hrs was obtained in cultivations proving the general suitability of this reactor concept for the application of bacterial processes. The combination of intelligent software sensor control strategies and currently improving (single-use) sensors will lead to a reduction of current drawbacks and improve control of bacterial fed-batch processes. The availability of single-use bioreactors for microbial cultivations widens their potential, not only in biopharmaceutical processing, but also as a pre-culture bioreactor for large scale processes and as a suitable tool in bioprocess development.

Decrease time to produce usable protein by maximizing target protein yields through transient transfection. The TransIT-PRO® Transfection Kit uses animal origin free components designed for high and reproducible nucleic acid delivery into suspension CHO and 293 derived cells. Since it is compatible with varied media formulations, the same media can be used for both transient and stable expression. The TransIT-PRO outperforms linear PEI in protein yield, while providing a cost-effective alternative to FreeStyle™ MAX and 293Fectin™ Transfection Reagents.