SUPPLY CHAIN MANAGEMENT
The foundation of a sound outsourcing strategy begins with due diligence in the selection of the raw materials and the packaging
materials. Qualifying and maintaining the supply chain is best accomplished by designing a strategy for business continuity.
This includes developing a supply chain that is aligned with one's business needs and that can adapt to an ever-evolving regulatory
environment.
Among the other challenges of sourcing cGMP-manufactured raw materials and components, the industry is faced with qualifying
and securing animal-free materials. In 1996, following the appearance of variant Creutzfeldt-Jakob disease (vCJD), the FDA
Center for Biologics Evaluation and Research recommended that manufacturers take necessary steps to ensure they are not using
bovine materials from cattle born, raised, or slaughtered in regions affected with bovine spongiform encephalopathy. The FDA
has issued various guidance documents for sourcing and processing such materials. However, with many materials still sourced
from animals, particularly in cases where there is only one known supplier of a given material, it is critical to scrutinize
the raw materials and other components of a manufacturing process and products.
Table 1. Points to consider when selecting a media supplier for cell culture media design and manufacturing
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In addition to vCJD, animal-derived materials used in cell culture media may contain infectious agents (e.g., viruses, mycoplasma,
prions). To most effectively minimize the risk of these agents, it is optimal to select a supplier that does not permit any
animal-derived materials in its cell culture media manufacturing facility. In addition, the presence of an antimicrobic in
a cell culture medium can mask the presence of viable microorganisms that can pose a significant risk. The risk of antimicrobics
in a cell culture medium can be reduced by sourcing from a supplier that does not use any antimicrobics in the facility.
The supplier's process must ensure there are no places where traceability could break down, gaps in batch history could exist,
or extraneous material or contaminants of any kind could enter the process between raw material receipt and delivery of the
media product to the end-user. The supplier must be regulated under current GMPs and confirmed by the FDA or a similar regulator
outside the US, or certified to meet applicable ISO standards.
SUMMARY
When outsourcing cell culture media design and manufacturing, biopharmaceutical companies need to ensure highest safety levels.
To do so, one should seek a media supplier that can provide flexible cGMP manufacturing capabilities in a dedicated facility,
optimization services with custom solutions, supply chain management with stringent qualification, control and traceability
of raw materials and suppliers, and strong management of risks and regulatory exposure. The resulting benefits are listed
in Table 1.
K. Fritchman, J. Kuchibhatla, and Yann Pouliquen are bioprocess applications and scientific affairs managers, J. Brooks is
an R&D manager and S. Holdread is a project scientist, research and development, A. Imam is a senior manager, quality systems,
C. Velnoskey is a bionutrients market development and marketing manager, and V. Weinknecht is an industrial regulatory affairs
manager, quality management and regulatory compliance, all at BD Biosciences–Advanced Bioprocessing, Sparks, MD, 760.788.4577,
Kathie_Fritchman@bd.com
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