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. 

 does just that. The guide started 20 years ago as an in-house resource, but it didn't take long for the editors to realize how valuable it could be to the biopharmaceutical world. 

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. 

'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 

, 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 

 useful. If you note any corrections or additions that are needed, please write to us.  

After all, even editors need to be edited. 

American Association for Laboratory Animal Care, 

a group that proposes standards for the care of laboratory animals and accredits facilities meeting those standards. 

   Removal of a particular molecule from a sample by accumulation into a bound water volume such as might be present in a densely fibrous material. Compare to 

 Unlike with classical drugs, ADRs are more likely to kill a biopharmaceutical development project than is a lack of efficacy.			

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. 

Advisory Committee on Genetic Manipulation, 

the British equivalent to the US Recombinant DNA Advisory Committee (RAC).			

the most frequently used solvent in HPLC, commonly used as an eluent. 

The raw material that is identified as directly related to the active chemical comprising the product, and is defined at the first stage during chemical synthesis at which part or most of the critical moieties are present. Defining active starting material defines the step at which compliance with cGMP requirements begins during manufacturing. For biopharma-ceuticals, this term is not used. 

Ampules are one biopharmaceutical packaging alternative.			

Describes a disorder as a one-time condition (an injury or infection), rather than as a chronic disease such as diabetes. 

Absorption, distribution, metabolism, and excretion.

an undesirable effect that may be caused by a study drug; also "adverse events"			

Adherence of molecules in solution or suspension to cells or other molecules—or to solid surfaces, such as chromatography media. Compare to 

Assays are the cornerstone of the analytical methods used in biopharmaceutical development.			

Acquired, accidental contaminants in a cell line, such as viruses and toxins; often infectious agents. 

Undesired effects or toxicity in a patient due to exposure (often to a drug or medical device, but not limited to those). Adverse events must be notified to the sponsor, who is required to perform a written investigation into the root causes, and may need to take other corrective or preventive actions. (See complaints, CAPA) 

Attraction between particles or substances; relatively speaking, a measure of the attraction of one molecule toward another. 

This scientist is using a benchtop bioreactor.			

A chromatographic method that makes use of the specific binding of one molecule to another; immunoaffinity chromatography uses antibodies, for example, and metal affinity chromatography uses chelation. 

(or tail)   An amino acid sequence added to a protein to facilitate purification by affinity chromatography. 

A polysaccharide (sugar) obtained from seaweed and used as a solidifying agent (agar) in microbial culture; also used in gel electrophoresis. 

A clustered mass, as of protein molecules; or to cluster together in such a way. Aggregates of cells (solid, fluffy, or pelletized) can clog the pores of filters or other fermentation apparatus. 

one of over 20 naturally occurring amino acids. 

Protein constituents of blood plasma and serum also found in muscle, egg white, and milk. 

 The introduction, by substitution or addition, of an alkyl group into an organic compound; alkylating agents are various substances that contain an alkyl radical and that can, therefore, replace a hydrogen atom in an organic compound; alkylation is used to prevent refolding of already reduced proteins during peptide mapping. 

 A coil or spiral element of protein secondary structure. 

Hydrolysis of a protein or peptide into its individual residues (free amino acids), followed by chromatographic separation and UV-vis detection for analytical purposes. 

Biopharmaceutical development, manufacturing, and analytical methods use a variety of buffer solutions.			

Articles

Nothing beats a good dictionary. It can clarify doubts, settle an argument, or prompt exploration into new areas of learning.

BioPharm International-08-02-2006

Guide to BioTerminology 2nd edition