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Finding guide to terms in these glossaries  Glossaries & taxonomies Site Map    Related glossaries include Cell biology

aliquot: (analytical chemistry) A known amount of a homogeneous material, assumed to be taken with negligible sampling error The term is usually applied to fluids. The term "aliquot" is usually used when the fractional part is an exact divisor of the whole; the term "aliquant' has been used when the fractional part is not an exact divisor of the whole. When a laboratory sample or test sample is 'aliquoted' or otherwise subdivided, the portions have been called split samples. [IUPAC Compendium] 

Related term sample prep

autosampler: Automated sample loader, usually robotic, used  with chromatography and other analytical technologies.

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

baculovirus: The Baculovirus Technology meeting Sept 2008 featured talks from experts who are achieving breakthroughs and clinical success using the BEVS both for protein production and in development of vaccines.  Along with talks that address basic biological properties, the agenda featured case studies from industry leaders, and presentations about transduction, optimizing expression, automation, and baculovirus-derived vaccines in clinical trials.   ORDER CD

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

bioprocess: http://en.wikipedia.org/wiki/Bioprocess    http://en.wiktionary.org/wiki/bioprocessing 

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

bioprocessing:  Optimizing cell culture technology, optimizing mammalian cell lines, specialized protein expression systems, affinity tag protein purification. Bioprocessing Summit 2009 Aug, Cambridge MA

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

biotechnology: Genetic Manipulation & Disruption

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: Cell biology

cGMP current Good Manufacturing Practice
Questions and answers on current Good Manufacturing Practice http://www.fda.gov/cder/guidance/cGMPs/default.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

change control biopharmaceutical: In the life-cycle of biopharmaceuticals, manufacturing change is unavoidable.  Owing to the complex nature of the biopharmaceutical product, physicochemical and functional changes occur which can affect both safety and efficacy. Biopharmaceutical Change Control April 13-15, 2010 • San Diego, CA Program | Register | Download Brochure  Includes  Biologics comparability, Protein process Scale up, Manufacture & Licensing & Post Translational Modifications.

clone constructs & vectors: Successful engineering and designing of vectors and clone constructs leads to efficient production throughout the protein expression pipeline.  Protein expression bottlenecks frequently arise because functional proteins are difficult to produce as they fail to express, are expressed as insoluble aggregates, or cannot be purified by standard methods.  Thus, protein engineers are forced to return to the drawing board. This usually requires designing new cloning schemes including: lengthy verification and sequence analysis of the gene or protein of interest, moving a gene from one vector to another, transfecting the vector in an alternative host, re-characterizing the expressed protein, or any or all of the above. Researchers view this process as a linear pathway:  make an expression clone, try it out, and if it fails, go back to the beginning and start over--an inefficient, time-consuming and expensive process.  Engineering Vectors and Designing Clone Constructs  January 14-15, 2010 • Coronado, CA  Program | Register | Download Brochure 

comparability biologics: Biologics are constantly subject to change implementation.  These occur with scale-up from lab scale to small scale manufacturing, and further increases in scale as the drug progresses through development. Additional changes include change of manufacturing site, changes in formulation, or simply change of just one ingredient in the manufacturing process.  The pharmaceutical industry needs to ensure safety and efficacy and also regulatory approval but does not wish to be over zealous. Comparability at all Stages of Development April 14-15, 2010, San Diego CA

cultured cells: Cell biology

difficult to express proteins:  Membrane proteins, ion channels, toxins, vaccines and other “finicky” proteins often are the best choices for therapeutics, yet their successful expression is rife with roadblocks and challenges. PEGs Protein Engineering Summit May 2010,Boston MA     Difficult to express proteins 

See also Expression genes & proteins

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

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

GCP Good Clinical Practice: Drug approvals & clinical trials

GLP Good Laboratory Practice:  The course will provide detailed information and the current state-of-the-art knowledge on “must know” topics such as writing SOP’s, the do’s and don’ts for the GLP audit, and Quality Assurance.  GLP Bioanalysis Jan 2009 San Francisco CA

Bioresearch Monitoring, Good Laboratory Practices, GLP References and Guidance, FDA http://www.fda.gov/ora/compliance_ref/bimo/glp/default.htm

Broader term: GxP

Good Manufacturing Practice:  http://www.fda.gov/cdrh/comp/gmp.html Q&A on cGMP Current GMP for Drugs http://www.fda.gov/cder/guidance/cGMPs/default.htm   http://en.wikipedia.org/wiki/Good_Manufacturing_Practice  

Broader term: GxP

GxP: A collective term used to refer to the regulations and guidances governing the research, development, testing, and manufacturing of drugs, medical devices, and biologics. John Stromp, The Basics of GxPs, Journal of GXP Compliance http://www.ivthome.com/free/gxp/gxpbasics.htm 

Narrower terms: GCP, GLP, GMP

host expression: Although most scientists would argue that the science of protein expression is a mature one, there still exist many issues with yields, glycosylation, folding, inclusion bodies, and so on.  There is still much that can be learned to overcome these challenges.  New hosts are emerging that will provide solutions to these ongoing problems.  Enhancing Host Expression January 11-12, 2010 • Coronado, CA  Program | Register | Download Brochure 

lyophilization:  Strategies for Successful Formulation, Cycle Development and Optimization, Regulatory Compliance, Validation, and Scale Up” covers the latest trends and challenges in lyophilization, spray drying, and foam drying with a focus on: developing a scientifically sound formulation, optimizing the lyophilization process, successful cycle development and process control, strategies for scale-up from R&D to production, vaccine and biologics freeze/thaw and formulation, container/closure systems, and overcoming tech transfer challenges.
Lyophilization & Spray Drying January 14-15, 2010 • Coronado, CA  Program | Register | Download Brochure

membrane proteins: Membrane proteins have long been recognized as major drug targets, and delineating their structure and function have been strong foci. However, a smaller percentage of stalwart researchers have been dauntless enough to tackle the challenges of extracting, expressing and purifying these formidable proteins.  In particular, removing membrane proteins from their hydrophobic environment and keeping them stable in an aqueous state is a significant accomplishment that will be discussed in this meeting both through case studies and through sharing of protocols.  Membrane Proteins January 13-14, 2010 • Coronado, CA Program | Register | Download Brochure    

Proteins which are found in membranes including cellular and intracellular membranes. They consist of two types, peripheral and integral proteins. They include most membrane- associated enzymes, antigenic proteins, transport proteins, and drug, hormone, and lectin receptors. MeSH, 1977

Despite the importance of membrane proteins, the knowledge of their high resolution structures and mechanisms of action has lagged far behind the knowledge of these properties of proteins in general. This has resulted from the difficulty of obtaining x-ray diffraction- quality crystals for the membrane proteins and the difficulty of applying well- developed solution NMR methods to the study of most membrane proteins. ... in the recent past, advances in methods for crystallization and analysis of proteins by x-ray and electron diffraction methods, and improvements in NMR methods, have led to new opportunities. Further, the solution of crystal structures, once suitable crystals are obtained, has, in many cases, become sufficiently routine, that crystallization itself is often the more challenging undertaking. Structural Biology of Membrane Proteins, NIH, US February 11, 2002, PA NUMBER: PA-02-060  http://grants.nih.gov/grants/guide/pa-files/PA-02-060.html

Membrane proteins play a crucial role in many cellular and physiological processes. They are essential mediators of material and information transfer between cells and their environment, between compartments within cells, and between compartments comprising the organ systems. Functionally normal membrane proteins are vital to health and specific defects are associated with many known disease states. Membrane proteins are the targets of a large number of pharmacologically and toxicologically active substances and are responsible, in part, for their uptake, metabolism, and clearance. 

Proteins closely associated with a cell membrane. Particularly difficult to determine structures of, but progress is being made recently with improved technologies.

Narrower term: Pharmaceutical biology G-protein-coupled receptors GPCRs; Protein categories membrane transport proteins
Related term: Microarray categories membrane microarrays

membrane transport proteins: Membrane proteins whose primary function is to facilitate the transport of molecules across a biological membrane. Included in this broad category are proteins involved in active transport (BIOLOGICAL TRANSPORT, ACTIVE), facilitated transport and ION CHANNELS.   MeSH 2002 

Classification, glossary of membrane transport proteins, IUBMB International Union of Biochemistry and Molecular Biology, 2002, 13 definitions http://www.chem.qmul.ac.uk/iubmb/mtp/intro.html#glossary 

Are  there any transport proteins which are not membrane proteins?

Broader term: carrier proteins

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

Google microreactors = about 165,000 Nov. 12, 2006; about 148,000 Apr 6, 2007
microbioreactors = about 962 Nov 12, 2006; about 554 Apr 6, 2007

PepTalk The Definitive Protein Focused Event Jan 12-16, 2010 San Diego CA

post- translational modifications: 

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 Analytical Technology: Concepts and principles, Mark L. Balboni, Pharmaceutical Technology, Oct. 2003 http://www.kminc.com/documents/PT6350e.pdf 

Process Analytical Technology tools:  In the PAT framework, these tools can be categorized 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.  FDA CDER PAT webpage http://www.fda.gov/cder/ops/pat.htm  

process chemistry:  Sessions Include: Challenges in Process Development of API Synthetic Routes, Tools for Optimization and Scale-up,  Impact of QbD on Process Development, Impact of Genotoxicity Concerns on Process Development, Biocatalysis, Separation at Scale: Chromatography and Crystallization Mastering process chemistry, Nov 2008, Philadelphia PA

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  

process R&D: Tight timelines and stringent budgets have become the norm in today’s R&D environment, exerting pressure on researchers to streamline chemical processes. To meet that goal, process chemists must be able to identify and resolve hurdles efficiently. The Process R&D Summit will present the tools and methodologies researchers need to address the challenges they are grappling with. The program will strive to address: aspects of green chemistry, optimizing final form (including crystallization), bio- and chemo-catalysis, automation, and outsourcing,  Process R&D Summit, Oct. 15-17, 2007, Philadelphia PA

process scale up: Protein Scale-Up, Process Change & Technology Transfer explores strategies to successfully reach larger scale, while examining economic drivers, outsourcing and platform technologies, in light of the regulatory environment that governs change implementation. The meeting will include a focus on how larger companies employ continuous process improvements to reduce waste and increase downstream efficiencies. Protein Scale-Up, Process Change & Technology Transfer April 2010, San Diego CA

protein aggregation: Drug discovery & development

protein characterization: Characterization, Purification & Screening” (formerly “Protein Expression”) conference will explore the successful methods and technologies currently being used, or in development, to provide the quantity and quality of proteins necessary for upstream research and drug development.  The 2010 Meeting continues the strong tradition of addressing research and development throughout the protein expression pipeline from initial steps, to efficient expression system design.  Case studies will shed light on the manufacture of modified gene cells as well as cell clone characterization and purification of proteins from high producers.
Protein  Characterization, Purification and Screening  January 13-14, 2010 • Coronado, CA  Program | Register | Download Brochure

protein expression: Great strides have been made in the expression of proteins for structure and characterization studies, as well as for therapeutics and diagnostics. However, with these strides have come new obstacles. Higher throughput expression and purification, as well as more flexible expression systems and techniques are now in even greater demand to support the needs of the research pipeline. It has become even more important to prevent problems in protein expression by wise choices in data analysis well before the task goes into the laboratory. Protein Expression 2009 Oct Hannover Germany

See also Expression gene & protein

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:  Insight Pharma Report forthcoming 2009 

Although therapeutic antibodies have come a long way in the past several years, many problems still exist in the production and use of these complex molecules. The negative qualities of these proteins, including immunogenicity, delivery difficulties, and the high cost of production, among others, have made the outcomes of their production and use less than satisfactory. In order to improve or eliminate these negatives, it is critical to find new ways to engineer antibodies, new antibody alternatives (such as mimetics, fragments, etc.) and novel ways to scale up production to provide large amounts of these proteins in a cost-effective way. Antibodies from Bench to Bedside 2009 Oct Hannover Germany

protein purification: Consistently producing proteins of high quality demands a robust purification process, especially when scaling up to large quantities.  Purifying and recovering proteins is typically viewed as a time-consuming bottleneck.  The Purification & Recovery meeting will explore the latest trends and tools through case studies presented by leaders in the development of biologics who will pass on their experience and data to help you overcome the challenges and increase the quality and quantity of purified protein.
Protein Purification & Recovery  January 11-12, 2010 • Coronado, CA  Program | Register | Download Brochure

Consistently producing proteins of high quality demands a robust purification process, especially when scaling up to large quantity.  Protein purification and recovery Jan 2009, San Diego CA

protein production: PepTalk: Protein Production, Jan 2009, San Diego CA

The number of biologics in development is rising distinctly with numerous new targets under investigation. This biologic boom puts pressure on existing manufacturing facilities stretching resources and capacity. What are the unique needs for manufacturing biological products? How can biologics be produced safely? What are the facility requirements to ensure success? 

protein scale-up and manufacture: Protein challenges, protein misfolding and aggregation, tech transfer   Protein scale-up & manufacturing: Harnessing Complexity PEGs, April 2009, Boston, MA

As the market for proteins continues to expand, efficient production systems are increasingly needed to meet the growing demand. Solutions require mastery of proteins'  biological properties as well as fastidious process controls and innovative protocols. Cutting time, increasing yield, and ensuring safety remain constant hurdles along with the inherent demands of proteins' nature.

protein science: Many of the original workhorse technologies and methodologies continue to be in the forefront of Protein Expression. However, new technologies are emerging that hold the promise of improving yields, simplifying isolation and characterization and advancing the capabilities of protein engineering for the next century. Next generation technologies for proteins science 2009 Oct Hannover Germany

sample: 1. In statistics, a group of individuals often taken at random from a population for research purposes 2. One or more items taken from a population or a process and intended to provide information on the population or process. 3. Portion of material selected from a larger quantity in some manner chosen so that the portion is representative of the whole. [IUPAC Tox] 

Related terms: aliquot, autosampler  See also Microarrays sample

sample prep, sample preparation:  Extracting, creating and keeping samples and templates of highest quality are the key factors for producing high-throughput data of optimal quality. For successful data output, state of the art information on the rapidly emerging integration of technologies is necessary. Proteomic  and Genomic Sample Prep, May 19-21, 2008, Boston MA 

Related terms: LIMS Laboratory Information Management Systems,  aliquot, microtiter plate, solid phase extraction, split sample;  Labels, signaling & development :Ultrasensitivity single cell detection, single molecule detection;    Proteins  depletion, pre- fractionation; Cell biology LCM Laser Capture Microdissection, subcellular fractionation; others?

vaccine manufacturing: The practical side of providing vaccines for the world – part science, part art – will be explored in the “Production & Manufacturing of Vaccines” meeting, including the analytics necessary for ensuring comparability, quality, and meeting regulatory requirements. From characterizing raw materials to increasing yield, the numerous pieces of the manufacturing puzzle will be addressed by experts who have gained greater insight through their own hands-on experiences. Production and Manufacturing of Vaccines  Aug  2009 Providence RI

vectors: See clone constructs & vectors

Bibliography
Bioprocess International, Glossary of Terms, 2009  http://www.bioprocessintl.com/default.asp?page=glossary    
Bioprocess International, Language of expressions, 2009 http://www.bioprocessintl.com/default.asp?page=glossary&TopicID=5 
Bioprocess International, Vaccines & immunology, 2009 http://www.bioprocessintl.com/default.asp?page=glossary&TopicID=4 
Biopharm International , Bioterminology, 2006 http://biopharminternational.findpharma.com/biopharm/article/articleDetail.jsp?id=362006 About 300 terms

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