Nothing beats a good dictionary. It can clarify doubts, settle an argument, or prompt exploration into new areas of learning.
Unfortunately, a good dictionary can be hard to find. Quality resources for general vocabulary abound; the challenge is to find one that includes the specialized terms of the industry and defines them for that context.
The text brings together in one place terms and acronyms from numerous technical, scientific, and engineering fields, such as chemistry, microbiology, molecular biology, engineering, facility design, CGMPs, regulatory affairs, and biotech patent law.
BioPharm International's "Guide to" series historically has included glossaries on individual topics, such as cell culture and fermentation. However, this lexicon features the collective definitions found in all of our series' guides, plus many more. Thus, it is the guide to the guides.
Creating or updating a glossary raises many questions. For example, are some terms too simple to be included? We opted for comprehensiveness, making the guide useful to everyone—even those new to the industry.
Are certain acronyms too obvious to define? Again, we decided on broad inclusion. A knowledgeable reader can gloss over a definition not needed, but an uninformed individual may stumble, miss the intended meaning, or perhaps lose interest altogether.
Lastly, how basic should the definitions themselves be? As you'll see, we provide quick, basic explanations that are relevant to the biopharmaceutical industry. Our definitions are suitable for those with or without a technical or scientific background.
This second edition contains 196 new terms, and revises another 96. Many of the additions relate to industry and regulatory concepts introduced since the first guide was published, such as design space, and other terminology from recent ICH guidelines. Other updates reflect the evolution of US regulation—for example, to reflect the shift in the authority over most biologics from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER).
We also added 19 terms related to risk management, including hazard analysis and critical control point (HACCP), and failure modes and effects analysis (FMEA).
And lastly, because of space limitations, this new edition omits the section on 21 CFR 11.
We hope that you find this Guide to Bioterminology useful. If you note any corrections or additions that are needed, please write to us.
After all, even editors need to be edited.
Laura Bush Editor in Chief
THE BIOPHARM LEXICON
AALAC American Association for Laboratory Animal Care, a group that proposes standards for the care of laboratory animals and accredits facilities meeting those standards.
accelerated stability tests Studies in which the product is stored under stress conditions (for example, 45°C and high humidity over 3–6 months) and observed for signs of degradation; used to predict long-term storage patterns.