Commercializing a new cell therapy demands optimal performance at every stage: upstream processing, downstream processing, process development, testing and manufacturing services. On the cutting edge of regenerative medicine, biopharmaceutical manufacturers need a partner with a proven track record of advancing cellular therapy product development and manufacturing, as well as the ability to adapt to client needs. Thousands of sophisticated products and tools are used in support of these efforts, and any inefficiency can lead to bottlenecks that slow progress within highly compressed timelines. Consequently, each step in cell therapy manufacturing must meet rigorous standards of quality and efficiency. Solving these potential bottlenecks in cell therapy commercialization requires optimization of cell therapy manufacturing platforms, media and reagents, characterization tools, process development services, and testing.
As a new therapy progresses from preclinical studies to manufacturing, cell culture media and supplements must be validated for the specific application and expansion format. Requirements include easy set-up and use, sterile processing, safe product storage, and vendor support with validation, quality, and regulatory compliance.
High raw material quality, traceability, and lot-to-lot consistency are critical requirements, as is compatibility with the cell therapy and its application. Selection of reliable vendors is a key consideration, ensuring a stable upstream supply chain over the entirety of a multi-year project.
Microcarrier-based bioreactor expansion of adherent cells can make manufacturing more cost-effective and efficient. Scalability, ease of sampling, and a closed-system design for downstream processing are characteristics of a robust and predictable manufacturing solution that also enhances facility flexibility; other advanced features include automated systems and easy traceability via in-line monitoring, on-demand control, and data logging.
Providing gentler manipulation of patient and reference cells, acoustic technologies are gaining popularity for concentration and wash, aggregate processing, and perfusion. They impart minimal energy and stress while simplifying cell therapy manufacturing with easy adaptability to varied processes. A modular design also makes them flexible and easy to use.
High cell yields are key if large-scale industrialized production of adherent-dependent cultures is to be cost-effective. Manufacturers consequently prefer optimized downstream solutions that enable effective cell separation from substrates for high cell recovery. Another notable trend is greater emphasis on raw materials that are animal-origin free.
Supply chain management is a must to ensure that samples arrive in safe condition at the manufacturing facility, and later at hospitals for administration to patients. Cryopreservation is effective when combined with high-quality reagents that are selected with several factors in mind: product characteristics and sensitivity, complexity of manufacturing logistics, product release testing, and patient location.
Process bottlenecks can often be avoided with integration of the right cell therapy manufacturing platforms, media and reagents, characterization tools, and testing. Building this expertise in-house can be costly, however, leading many firms to seek a proven partner for product development and manufacturing. Benefits of a world-class partner include acceleration of research into scalable commercial processes, good manufacturing practice (GMP) compatibility, fast knowledge transfer, and increased patient access through cost-effective, robust manufacturing.
The complexity and risk associated with introducing new cell therapeutics can be mitigated by outsourcing biosafety testing, as well as biomanufacturing. A world-class partner can provide biosafety testing services that meet all good laboratory practice (GLP) and good manufacturing practice (GMP) regulations within accelerated timeframes, in addition to fully compliant viral and gene therapy manufacturing services ranging from small to commercial scale. These efficiencies can benefit firms and patients alike, speeding availability of urgently needed drugs that are effective, safe, and affordable.
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