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Pharmaceutical bioprocessing & manufacturing glossary & taxonomy
Evolving Terminologies for Emerging Technologies
Comments? Questions? Revisions?  Mary Chitty 
mchitty@healthtech.com
Last revised March 04, 2014
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antibody drug conjugate manufacturing: ADC Development and ManufacturingADC Development and Manufacturing  May 7-8, 2014 • PEGS Boston, MA Program | Register | 


antibody engineering:
Engineering AntibodiesEngineering Antibodies  May 7-8, 2014 • PEGS Boston, MA Program | Register | 

antibody purification: 

baculoviridae: Family of INSECT VIRUSES containing two subfamilies: Eubaculovirinae (occluded baculoviruses) and Nudibaculovirinae (nonoccluded baculoviruses). The Eubaculovirinae, which contain polyhedron-shaped inclusion bodies, have two genera: NUCLEOPOLYHEDROVIRUS and GRANULOVIRUS. Baculovirus vectors are used for expression of foreign genes in insects. MeSH 1991

biocatalysis: The application, both actual and potential, of biological catalysts (including whole cells or isolated components thereof, natural and modified enzymes and catalytic antibodies) for the synthesis, interconversion or degradation of chemical species. In addition to papers describing the synthetic applications of biotransformations the journal particularly welcomes papers focusing on the mechanistic principles, kinetics and thermodynamics of biocatalytic processes, the chemical or genetic modification of biocatalysts and the activity and stability of biocatalysts in non- aqueous and multi- phasic environments, including the design of large scale biocatalytic processes. The scope of the journal also encompasses biomimetic systems and environmental applications of biocatalysis where the mechanistic principles are understood or novel biocatalytic activities are involved. Biocatalysis and Biotransformation, Aims and scope,  Taylor & Francis http://www.tandf.co.uk/journals/titles/10242422.html  Related terms: biotransformation; Biomaterials  biomimetic

biomanufacturing: Biomanufacturing is defined here as the production of large molecules that cannot be directly synthesized or extracted. Relatively small, simple proteins are produced by microbial fermentation (e.g., insulin and human growth hormone in E. coli, recombinant hepatitis B vaccine in yeast). Larger, more complex proteins such as EPO, tPA, and monoclonal antibodies require the addition of specific sugar side chains to the protein backbone (a process termed glycosylation). Only mammalian cells — Chinese hamster ovary cell lines are the predominant industry standard — can naturally attach the right sequence of sugar molecules and fold the protein into its correct shape for it to be functionally active.  Technology Roadmaps The Canadian Biopharmaceutical Industry Technology Roadmap — Biomanufacturing, Industry Canada 2010 http://www.ic.gc.ca/eic/site/trm-crt.nsf/eng/rm00379.html 

bioprocess: Bioprocesses use living cells and their components to develop innovative products. The Sector develops microbial, enzymatic and advanced cell-based processes from inception to industrial scale. These processes can then be used by industrial partners for the production of valued compounds such as bio-therapeutics, enzymes, green products and other biological products. BRI's unique bioprocess facility is equipped for the production of large amounts of drug target protein, in a biologically active form, for further studies along the drug development process. BRI's scientists and engineers also develop unique expression vectors, and use both fed-batch and perfusion strategies in the growth and production of recombinant proteins in bacteria, yeast, insect, and mammalian cells. For a specific protein, the Bioprocess research team can develop a novel, integrated recombinant production process and scale it up, through iterative processing, to optimize the yield and biological activity of the product. Bioprocess Sector, National Research Council Canada 2009 http://www.nrc-cnrc.gc.ca/eng/programs/bri/bioprocess-sector.html 
http://en.wikipedia.org/wiki/Bioprocess    http://en.wiktionary.org/wiki/bioprocessing 

bioprocess engineering:
http://en.wikipedia.org/wiki/Bioprocess_Engineering 

bioprocessing:
 
The Bioprocessing SummitThe Bioprocessing Summit August 18-22, 2014 • Boston, MA Program | Register | Download Brochure

bioreactors: Tools or devices for generating products using the synthetic or chemical conversion capacity of a biological system. They can be classical fermentors, cell culture perfusion systems, or enzyme bioreactors. For production of proteins or enzymes, recombinant microorganisms such as bacteria, mammalian cells, or insect or plant cells are usually chosen. MeSH 1997  Narrower terms: microreactors, microbioreactors

biosimilars: Regulator
biotechnology: Biologics

  Biotherapeutics Analytical Summit	Biotherapeutics Analytical Summit March 24-28, 2014 • Baltimore, MD Program | Register | Download Brochure  

Characterization of BiotherapeuticsCharacterization of Biotherapeutics May 5-6, 2014 • PEGS Boston, MA Program | Register | 

biotransformation: Conversion of a chemical from one form to another by a biological organism. NLM Toxicology Tutor, Glossary  http://sis.nlm.nih.gov/enviro/toxtutor/Tox1/glossb.htm 

The process whereby a substance is changed from one chemical to another (transformed) by a chemical reaction within the body.  Metabolism or metabolic transformations are terms frequently used for the biotransformation process.  However, metabolism is sometimes not specific for the transformation process but may include other phases of toxicokinetics.  National Library of Medicine, Toxicology Tutor  former definition for biotransformation

cell culture: As bench scientists strive to reach ever higher titers, the omic sciences, such as metabolomics and genomics, open up emerging pathways for improving cell culture, as do performance excellence approaches (QbD, PAT, DoE). Along with discussing these breakthrough technologies, experts will also shed light on optimizing conditions as well as cell biology to help achieve demanding goals more often and more consistently. Optimizing Cell Culture Technology August 20-21, 2012 • Boston, MA Program | Register | Download Brochure Optimizing Cell Culture Technology

The in vitro propagation of animal of plant cells, in an artificial nutrient medium. IUPAC Biotech

cell culture techniques: A technique for maintaining or growing CELLS in vitro. Cultures of dispersed cells derived directly from fresh TISSUES are called primary cell cultures. Cultures may also derive from established CELL LINE usually stored frozen.  MeSH 2005 (1996)  Narrower terms: CHO cells, cell line;  hybridomas, mammalian cell culture, stem cells

cell line: Defined unique population of cells obtained by culture from a primary implant through numerous generations. IUPAC Tox Often mammalian.  Narrower terms: CHO cells, cell strain; Broader term: cell culture
ATCC American Type Culture Collection  http://www.atcc.org/ 

cell strain: Cells having specific properties or markers derived from a primary culture or cell line. IUPAC Tox

cGMP current Good Manufacturing Practice: Questions and answers on current Good Manufacturing Practice  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124740.htm 
Pharmaceutical cGMPs for the 21st Century: A Risk Based Approach Final Report, 2004  http://www.fda.gov/cder/gmp/gmp2004/CGMP%20report%20final04.pdf  
See also GMP Good Manufacturing Practice

CHO cells Chinese Hamster Ovaries: Chinese hamster ovary (CHO) cells are the predominant cell factory for the production of biotherapeutics. Nevertheless, even with the recently released CHO cell DNA sequence, more research is required to harness their production potential. Harnessing CHO Cells: The workhouse of production DVD 2012 http://www.chi-peptalk.com/peptalk_content.aspx?id=112924 

clone constructs & vectors: Engineering Genes, Vectors, Constructs and Clones	Engineering Genes, Vectors, Constructs and Clones January 13-14, 2014 • PepTalk Palm Springs, CA Program | Register | Download Brochure

comparability biologics: Comparability and Developability  March 27-28, 2014 • Baltimore, MD Program | Register | 

cultured cells: Cells propagated in vitro in special media conducive to their growth. Cultured cells are used to study developmental, morphologic, metabolic, physiologic, and genetic processes, among others MeSH 1972

Dynamic Light Scattering DLS: Since its market introduction circa 30 years back, dynamic light scattering (DLS) has occupied a position of increasing popularity within the area of protein aggregate detection and characterization, due in large part to the non-invasiveness of the technique, the minimal sample volume & concentration requirements, and the quickness of data collection. While modern instrument design and software have removed much of the mystique traditionally associated with the technique, data interpretation is still an area of frustration for many DLS users. This workshop covers the basic theory behind DLS instrumentation, with a focus on the do's & don'ts when it comes to data interpretation.  Dynamic Light Scattering Theory DVD January 11, 2011 •  

enzyme expression: Higher Level Expression of EnzymesHigher Level Expression of Enzymes  May 8-9, 2014 PEGS Boston, MA Program | Register | 

Extractables and Leachables January 16-17, 2014 • PepTalk Palm Springs, CA Program | Register | Extractables and Leachables

expression vector:
http://en.wikipedia.org/wiki/Expression_vector Alternately expression construct

fluidic system: Device for synthesis or screening in which fluids such as reagents or assay buffers may be directed to specified locations by the opening and closing of valves in a stationary network of tubes and wells. Related term: robotic systems; Narrower term microfluidics Nanoscience & Miniaturization

Flexible Manufacturing of BiopharmaceuticalsFlexible Manufacturing of Biopharmaceuticals January 15-16, 2014 • PepTalk, Palm Springs, CA Program | Register | 

freeze drying See lyophilization

GAMP Good Automated Manufacturing Process: Wikipedia http://en.wikipedia.org/wiki/Good_Automated_Manufacturing_Practice 

Good Manufacturing Practice:  Q&A on cGMP Current GMP for Drugs http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124740.htm 
Wikipedia  http://en.wikipedia.org/wiki/Good_Manufacturing_Practice  Broader term: GxP

Higher Level Expression of EnzymesHigher Level Expression of Enzymes May 8-9, 2014 • PEGS Boston, MA Program | Register | 

lyophilization:  Lyophilization and Emerging Drying Technologies January 15-16, 2014 • PepTalk Palm Springs, CA Program | Register | 

Definitions, Freezedryinginfo, Millrock Technologies http://www.freezedryinginfo.com/Definitions.html  about 30 terms


microreactors:  Wikipedia  http://en.wikipedia.org/wiki/Microreactor   Alternately: microbioreactors  

molecular farming: The large scale production of pharmaceutically important and commercially valuable RECOMBINANT PROTEINS MeSH 2011

particulates - characterization & analysis:  Sub-visible particles present in these products are a product quality attribute and a potential patient safety concern yet to be fully explored. Early and consistent particle detection, quantitation and control throughout the product life cycle of these drugs from development to commercial lot release is critical in mitigating any concerns. This requires appropriate analytical methods which can be applied to biopharmaceuticals across a large variety of protein concentrations and modes of administration. 

pharming: Use of  transgenic animals to produce drugs in their milk, urine or eggs.  Transgenic plants can also be used. (Tobacco is said to be particularly amenable to this application).     Related terms: Genomics crop genomics; Assays & screening  phenotypic screening

Process Analytical Technology PAT:  A system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. It is important to note that the term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner. .. There are many current and new tools available that enable scientific, risk-managed pharmaceutical development, manufacture, and quality assurance...  In the PAT framework these tools can be characterized as Multivariate data acquisition and analysis tools, Modern process analyzers or process analytical chemistry tools, Process and endpoint monitoring and control tools, Continuous improvement and knowledge management tools. An appropriate combination of some, or all, of these tools may be applicable to a single-unit operation, or to an entire manufacturing process and its quality assurance. Product and Process Development Group Meeting of the PAT Subcommittee, CDER, FDA, Gaithersburg MD, June 12- 13, 2002 http://www.fda.gov/ohrms/dockets/ac/02/minutes/3869M1_01_PATSubcommittee-Product-ProcessWG.pdf

A system for designing, analyzing, and controlling manufacturing processes through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials, to ensure final product quality. The term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner. The emphasis in PAT is on the manufacturing process to amplify the basic premise of the current drug quality system: Quality cannot be tested into products; it should be built-in or should be by design. AAPS PAT Focus Group, American Association of Pharmaceutical Scientists,  http://www.aapspharmaceutica.com/inside/focus_groups/PAT/index.asp#def

process chemistry:
  A list of terms with their definitions used in "Process Chemistry/Manufacturing of Active Pharmaceutical Ingredients" and "Pharmaceutics"; About 850 terms directly related to each of the fields of "Process Chemistry/Manufacturing of Active Pharmaceutical Ingredients" and "Pharmaceutics"; will be compiled and defined by this expert group for dissemination to the scientific community. This will help achieve a common definition base across the various publications in this field. In addition, a more uniform use of these terms should assist in the future construction of glossaries pertaining to this continually evolving field's information. IUPAC Glossary of terms used in process chemistry/manufacturing of active pharmaceutical ingredients, and pharmaceutics, project Number: 2001-049-2-700, 2007 provisional recommendations.  http://old.iupac.org/reports/provisional/abstract07/breuer_300408.html  

Efficient Process Chemistry  May 22-23, 2014 • Boston, MA Program | Register |
process scale-up:
Scaling Up and Down Strategies for Protein Production  May 5-6, 2014 • PEGS Boston, MA Program | Register | 

Protein Agregation and Stability in BiopharmaceuticalsProtein Aggregation and Stability in Biopharmaceuticals May 8-9, 2014 • PEGS Boston, MA Program | Register | 

protein characterization:  Characterization of BiotherapeuticsCharacterization of Biotherapeutics May 5-6, 2014 • PEGS Boston, MA Program | Register | 

protein expression: 

See also Expression gene & protein

protein expression difficult:  Membrane proteins, ion channels, toxins, insoluble proteins, low abundance protein complexes, vaccines and other “finicky” proteins often are the best choices for therapeutics, yet their successful expression is rife with roadblocks and challenges.  Difficult to Express ProteinsDifficult to Express Proteins May 5-6, 2014 • PEGS Boston, MA Program | Register | Download Brochure

protein expression- optimizing: Optimizing Protein ExpressionOptimizing Protein Expression May 7-8, 2014 • Boston, MA Program | Register | Download Brochure
See also protein expression,  Expression genes & proteins

protein process management: The demand for protein-based therapeutics grows by 50% each year, yet the time-consuming and often unpredictable nature of working with peptide and protein-based therapeutics is hampered by the tremendous cost of developing a product—up to $3 billion. 

protein production: Bioprocessing is the branch of biotechnology dealing with the production and purification of biological materials of commercial interest, mainly but not exclusively for the pharma industry. It is a wide-ranging discipline in which bioengineering, equipment design, molecular biology, cell genetics, cell culture technology, analytical chemistry, and polymer science are applied to the goal of rapidly, consistently and economically producing high-molecular weight, complex molecules. Insight Pharma Reports  Therapeutic Protein Production: A Changing Landscape 2010

protein purification:  Protein Purification and Recovery  January 13-14, 2014 • PepTalk Palm Springs, CA Program | Register | Protein Purification and Recovery


Rapid Access to Interventional Development RAID:
The National Institutes of Health (NIH) established NIH-RAID (Rapid Access to Interventional Development) to make available, on a competitive basis, certain critical resources needed for the development of new therapeutic agents. NIH-RAID is intended to reduce some of the common barriers between laboratory discoveries and clinical trials of new therapeutic entities. This program, supported by the NIH Common Fund provides access to contract services made available by various NIH Institutes and Centers. Available services include: production, bulk supply, GMP manufacturing, formulation, development of an assay suitable for pharmacokinetic testing, and animal toxicology. Available services now include the manufacture of recombinant proteins and monoclonal antibodies. RAID NIH Common Fund http://commonfund.nih.gov/raid/#RoleofthenihInst 

Recombinant Protein Expression and Production Recombinant Protein Expression and Production  January 15-16, 2014 • PepTalk Palm Springs, CA Program | Register | 

Single-Use Technologies and Continuous Processing in Biopharm Manufacturing  January 13-14, 2014 • PepTalk Palm Springs, CA Program | Register | 

tissue culture: See cell culture. IUPAC Biotech

Transient Protein Production January 16-17, 2014 • PepTalk, Palm Springs, CA Program | Register | Transient Protein Production

vaccine manufacturing: 


vectors: Yeast Artificial Chromosomes YACs:  Narrower term:  clone constructs & vectors

Bibliography
Bioprocessing Conferences http://www.chicorporate.com/Conferences/Upcoming.aspx?s=BPS
Bioprocessing Summit  http://www.chicorporate.com/bpd
PepTalk The Protein Science Week http://www.chi-peptalk.com/
Protein Engineering Summit PEGS http://www.pegsummit.com/

Bioprocessing CDs, DVDs http://www.chicorporate.com/Conferences/CompactDiscs.aspx?s=BPS
Bioprocessing Short courses http://www.healthtech.com/Conferences_Upcoming_ShortCourses.aspx?s=BPS

Insight Pharma Reports Bioprocessing and Manufacturing Series http://www.insightpharmareports.com/Bioprocess-Manufacturing-Reports/
Bioprocessing Barnett books http://www.barnettinternational.com/EducationalServices/Publications.aspx?j=Manufacturing

Bioprocess International, Glossary of Terms http://www.babylon.com/free-dictionaries/science/biology/BioProcess-International%E2%84%A2-Glossary/54602.html 
Biopharm International , Bioterminology, 2006 http://biopharminternational.findpharma.com/biopharm/article/articleDetail.jsp?id=362006 About 300 terms
Contract Pharma Glossary of Pharmaceutical and Biopharmaceutical Terms, revised annually 500 plus terms http://www.contractpharma.com/glossary 
Definitions, Freezedryinginfo, Millrock Technologies http://www.freezedryinginfo.com/Definitions.html  about 30 terms
ISPE International Society Pharmaceutical Engineering ISPE Glossary of Pharmaceutical and Biotechnology Terminology http://www.ispe.org/glossary  Manufacturing and regulatory
IUPAC  International Union of Pure and Applied Chemistry, Compendium of Chemical Terminology: Recommendations, compiled by Alan D. McNaught and Andrew Wilkinson, Blackwell Science, 1997. "Gold Book" 6500+ definitions. http://goldbook.iupac.org/
IUPAC International Union of Pure and Applied Chemistry, GLOSSARY FOR CHEMISTS OF TERMS USED IN TOXICOLOGY Clinical Chemistry Division, Commission on Toxicology, Pure and Appl. Chem., 65 ( 9):  2003- 2122, 1993. 1200+ definitions. http://www.iupac.org/reports/1993/6509duffus
MeSH Medical Subject Headings, PubMed http://www.ncbi.nlm.nih.gov/mesh 

A useful accessible guide to technology is William Bains' Biotechnology A-Z, Oxford University Press, 2003. About 400 entries/ definitions.  To order: http://www.oup.co.uk/isbn/0-19-852498-6  Particularly strong in bioprocessing and manufacturing technologies, and environmental applications, which are not areas of major emphasis in these glossaries.

Alpha glossary index
How to look for other unfamiliar  terms

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