As peptide-based therapies are increasingly becoming viable drug discovery and development targets, the industry is paying
more attention to the quality concerns that underlie peptide manufacturing processes. Peptide synthesis for pharmaceutical
manufacturing can be tedious and time-consuming given the complexity of the product and the lengthy, intricate synthesis process.
Regulatory compliance, quality control, and quality assurance efforts are critical for the successful development and manufacture
of peptides as active pharmaceutical ingredients. As a key element in the peptide production process, quality should be built
into every step, and thought of as a process parameter, not a process outcome.
Apart from general regulatory requirements and recommendations that apply to all drug manufacturing guidelines, including
the Code of Federal Regulations and ICH (Q7A) Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, there is only one guideline specifically dedicated to peptides, which makes it all the more easy to follow. Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances, issued in 1994, stipulates that the lot-release specifications—a set of tests and acceptance criteria that must be met before
a product is released—must be sufficient to ensure the identity, purity, strength, and potency of the peptide and to demonstrate
Of course, every product manufactured under current good manufacturing practices (cGMPs) must undergo a battery of analytical
tests. Each batch should be provided with a lot-specific certificate of analysis (CoA) documenting specifications, test methods,
and results. A typical CoA contains information on appearance, solubility, purity by gradient HPLC, molecular weight, as well
as peptide counter ion, water, and residual organic solvent content.
Bearing all these elements in mind in a holistic fashion is critical for implementing a sound quality system. Indeed, the key word for any effective approach to quality outcomes is system. Given that every component of a manufacturing
process contributes to the quality of the final product, without a comprehensive systems approach to the entire process, even
a minor misstep could compromise final outcomes.
A quality system in a pharmaceutical manufacturing environment comprises several components, including, but not always limited
to, facilities and equipment, laboratory controls, materials, packaging, and labeling. These components should be designed
to incorporate redundancies and fail-safes, because failure of one component can mean failure of the entire operation.
Overall, a focus on quality must have regulatory compliance as its ultimate goal. Adherence to cGMPs, coupled with a robust
documentation program, can ensure reproducible and verifiable quality procedures. A comprehensive systems approach that takes
into account every miniscule aspect of the manufacturing operation—from documentation to capital equipment—is the surest way
to guarantee final quality of your product.
Shawn Shirzadi is the vice president of quality at American Peptide Company Headquarters, Sunnyvale, CA, 408.733.7604, firstname.lastname@example.org