Perspective

26 June 2012

Changes Coming to FDA Quality System Requirements for Prefilled Injection Devices

By Michael Gross, PhD, RAC

This article reviews the current state of the development of quality system requirements for combination products, in particular prefilled drug delivery devices. As part of a series on US Food and Drug Administration (FDA) regulation of combination products, it discusses industry’s response to FDA’s proposed rule on quality systems for combination products and how manufacturers of combination products should prepare for compliance with the anticipated final rule and related guidance. [Read More...]

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26 March 2012

Demystifying CMC Regulatory Strategy for Biologics - Part 4: Challenges of Adventitious Agent Control

By John Geigert, PhD, RAC

This article explores Prions--“adventitious agents” that are microorganisms (including bacteria, fungi, mycoplasma/spiroplasma, mycobacteria, rickettsia, viruses, protozoa, parasites, TSE agent) that are inadvertently introduced into the production of a biological product. Three adventitious agents of primary concern for biologics are addressed in this article: prions, viruses and mycoplasmas.

[Read More...]

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6 February 2012

Demystifying CMC Regulatory Strategy for Biologics - Part 3: An Effective CMC Regulatory Strategy Is Possible

By John Geigert, PhD, RAC

Note: Demystifying, according to Merriam-Webster’s dictionary, is “to remove the mystery or mystique; to make rational or comprehensive.” This is the third part of a series on demystifying CMC regulatory strategy for biologics. Part 1 covered the complexity of biologic CMC regulation; Part 2 examined the major differences between biologics and chemical drugs; and Part 4 will examine the challenge of adventitious agent contamination control for biologics.

Failures in the chemistry, manufacturing and controls (CMC) regulatory strategy for biologics abound: a recombinant enzyme is delayed in gaining market approval because the US Food and Drug Administration (FDA) concludes that "the commercial process is not representative of the Phase 3 material used to establish the safety and efficacy profile; "a recombinant protein is rejected by the European Medicines Agency (EMA) because "with regard to Quality a large number of outstanding issues remained" (e.g., lack of product comparability, insufficient stability data, manufacturing process not adequately validated); a recombinant protein is withdrawn from the US market because a "minor change in the formulation" leads to spontaneous syncope (fainting). [Read More...]

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1 November 2011

Demystifying CMC Regulatory Strategy for Biologics - Part 2: Biologics Are Not Chemical Drugs

By John Geigert, PhD, RAC

Senior managers, especially if they have recently moved from the chemical drug side of the business into biologics, may raise the question of whether biologics are really different from chemical drugs or if this is just a perception. As clearly stated by the regulatory authorities, biologics are not chemical drugs and similar biologics are not biogenerics.

A glance at the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) websites clearly shows the agencies view biologics and their manufacturing processes as different from chemical drugs.

[Read More...]

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