New technologies bring new regulatory challenges. The biopharmaceutical industry must be cautious in its implementation of new scientific ideas and technology platforms — no matter how promising those might be. Regulators will look skeptically on any claim that isn’t backed up by good data, and with no solid history of successful use to build on, a company must have all the answers itself. How do compliance professionals anticipate what kinds of questions reviewers will ask when the time comes — and how can those in development laboratories and manufacturing suites best be prepared to respond to them? With all that in mind, this eBook addresses a number of new approaches to the regulation-defined areas of chemistry, manufacturing, and controls (CMC) for protein biologics.
Many new product modalities are challenging the old ways of thinking and doing things, and new bioprocess and analytical technologies can offer solutions to the problems they introduce. Meanwhile, those new technologies also suggest new methodologies for established and familiar product types. Changing legacy processes may not be feasible in most cases (because of associated regulatory hurdles), but the overall paradigm will shift over time as advanced platforms are applied to new projects going forward.
Ultimately all work performed under current good manufacturing practice (CGMP) must follow proper standard operating procedures (SOPs), including required documentation for eventual inclusion in regulatory filings such as biological license applications (BLAs). In this eBook, I have arranged sections on chemistry (product characterization, formulation, and cell-line development), manufacturing (platforms, single-use technologies, and continuous processing), and controls (modeling, process control, and data management) not to exactly reflect the regulations, but rather to follow a logical framework for discussion. From a regulatory standpoint, “CMC” sections are those parts of a filing that do not address preclinical and clinical product testing results.
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