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Pharmaceutical bioprocessing & manufacturing glossary & taxonomy
Evolving Terminologies for Emerging Technologies
Comments? Questions? Revisions?  Mary Chitty
Last revised January 12, 2015
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Chemistry term index   Drug discovery term index   Informatics term index   Technologies term index    Biology term index  Finding guide to terms in these glossaries  Site Map    Related glossaries include Biologics   Cell & tissue technologies  Drug delivery   Protein technologies

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 6-7, 2015 • Boston, MA Program | Register | Download Brochure update blurb

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 

biomanufacturing: For the remainder of this paper, we will define “biomanufacturing “ as “Use of living genetically modified organisms or living genetically modified cells to manufacture a product.” A genetically modified organism is defined as “an organism whose genetic characteristics have been altered by the insertion of a modified gene or a gene from another organism or by modification/disabling/deletion of a gene, using the techniques of genetic engineering.” A variety of living genetically modified organisms, such as bacteria, fungi, algae, plants and animals could be used for biomanufacturing. This broad definition of biomanufacturing includes in scope projects that address critical processes in the manufacture of biopharmaceuticals (health related) as well as nonbiopharmaceutical (non-health related) products. NIST,  MANUFACTURING: Manufacturing and Biomanufacturing: Material Advances and Critical Processes 2011 DRAFT

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 

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  

bioprocess engineering: 

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  March 9-13, 2015 • Baltimore, MD Program | Register | Download Brochure

Characterization of Biotherapeutics May 5-6, 2014 • PEGS Boston, MAProgram | Register | 

biotransformation: Conversion of a chemical from one form to another by a biological organism. NLM Toxicology Tutor, Glossary 

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. 
Accelerating Cell Line & Cell Culture Development May 7-8, 2015 • Boston, MA Program | Register | Download Brochure

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 

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 
Pharmaceutical cGMPs for the 21st Century: A Risk Based Approach Final Report, 2004   
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. CHO Cells January 21-22, 2015 • San Diego, CA Program | Register | Download Brochure

clone constructs & vectors: Engineering Genes, Vectors, Constructs and Clones January 19-20, 2015 • San Diego, CA Program | Register | Download Brochure

comparability: Part Three: Comparability for Biologics March 12-13, 2015 • Baltimore, MD Program | Register | Download Brochure

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 22-23, 2015 • San Diego, CA Program | Register | Download Brochure

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

freeze drying See lyophilization

GAMP Good Automated Manufacturing Process: Wikipedia 

Good Manufacturing Practice:  Q&A on cGMP Current GMP for Drugs 
Wikipedia  Broader term: GxP

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

lyophilization: Lyophilization and Emerging Drying Technologies January 21-22, 2015 • San Diego, CA Program | Register | Download Brochure
Lyophilization and Emerging Drying Technologies
Definitions, Freezedryinginfo, Millrock Technologies  about 30 terms

microreactors:  Wikipedia   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

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,

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.  

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 expression: Optimizing Protein Expression May 6-7, 2015 • Boston, MA Program | Register | Download Brochure

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 Proteins May 4-5, 2015 • Boston, MA Program | Register | Download Brochure

protein expression- optimizing:

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 21-22, 2015 • San Diego, CA Program | Register | Download Brochure
Protein Purification and Recovery

High-Throughput Protein Purification January 22-23, 2015 • San Diego, CA Program | Register | Download Brochure

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 

Recombinant Protein Expression and Production January 21-22, 2015 • San Diego, CA Program | Register | Download Brochure

Single-Use Technologies and Continuous Processing January 19-20, 2015 • San Diego, CA Program | Register | Download Brochure

tissue culture: See cell culture.
IUPAC Biotech

Transient Protein Production January 22-23, 2015 • San Diego, CA Program | Register | Download Brochure

vectors: See  clone constructs & vectors

Bioprocessing Conferences
Bioprocessing Summit
PepTalk The Protein Science Week
Protein Engineering Summit PEGS

Bioprocessing CDs, DVDs
Bioprocessing Short courses

Insight Pharma Reports Bioprocessing and Manufacturing Series
Bioprocessing Barnett books

Bioprocess International, Glossary of Terms 
Biopharm International , Bioterminology, 2006 About 300 terms
Contract Pharma Glossary of Pharmaceutical and Biopharmaceutical Terms, revised annually 500 plus terms 
Definitions, Freezedryinginfo, Millrock Technologies  about 30 terms
ISPE International Society Pharmaceutical Engineering ISPE Glossary of Pharmaceutical and Biotechnology Terminology  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.
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.
MeSH Medical Subject Headings, PubMed 

A useful accessible guide to technology is William Bains' Biotechnology A-Z, Oxford University Press, 2003. About 400 entries/ definitions.  To order:  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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