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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.

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

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

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

cultured cells: Cell biology

difficult to express proteins: Expression glossary

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

GCP Good Clinical Practice: Drug approvals & clinical trials

GLP Good Laboratory Practice:  "Must know" topics; include writing SOP’s, the do’s and don’ts for the GLP audit, Quality Assurance, outsourcing, and multiple standards. Topics to be covered at this conference: Drafting Standard Operating Procedures (SOPs). Method Qualification/Validation, GLP Inspections, 21 CFR 11, Digital Archiving, Laboratory Information Management Systems (LIMS), Documentation Process: Drafting Document Templates that Facilitate Reconstructability, Compliance, and Archive, GLP Compliance – The Challenge for Start-Ups, Quality Control/ Quality Assurance, Planning and Conducting Audits: How to Audit Effectively, FDA 483/Warning Letters, Case Analysis for GLP Compliance  GLP Bioanalysis Aug 22-23 2007 •  Cambridge MA 

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

lyophilization:  Topics include Regulatory and Compliance Issues: Being Prepared for FDA Inspections , Freeze Dryer Selection: Best Practices and Lessons Learned , Factory Acceptance Testing (FAT) and Future Validation, Developing a Scientifically Sound Formulation and Optimizing the Lyo Process , Points to Consider on Freeze Drying Process Design for Scale-Up, A Gentle PAT Approach to In-Line Control of the Lyophilization Process, Selection of Container/ Closure Systems for Lyophilization of Biological Products, Root Cause Analysis and Risk Assessment for Lyophilized Product, Matrix Validation Approaches for Lyophilized Products Lyophilization: Strategies for Successful Formulation, Cycle development, and Optimization, Regulatory Compliance, Validation and Scale-up Jan 9-11, 2008, San Diego CA

microreactors: Topics include Challenges of Switching from Batch to Flow Chemistry; Scaling Up and Improving Safety; Reproducibility; Handling Precipitates and Solids – is there a "Solution" in Sight? Are Microreactors Ready for General Use in Drug Discovery Laboratories? Microreactors: Integrating Flow Chemistry into Drug Discovery Molecular Medicine Short course Feb 27, San Francisco CA

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

PAT Process Analytical Technology: 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:  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

protein expression: Expression glossary

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 Process Management Jan 10-11, 2008 Coronado CA

protein production: 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?  Peptalk: Protein Production, Jan 10 - 11,2008, San Diego CA

protein scale-up and manufacture:  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 scale-up & manufacturing: Harnessing Complexity, April 30-May 1, 2008, Boston, MA

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: Manufacturing today’s vaccines involves adherence to regulatory requirements, appropriate facility design, a clear results-oriented process, quality control, validation, and adequate funding to drive the entire operation. Professionals working in vaccine production and facility operations will outline the numerous details comprising the manufacturing process, and will share advice to help vaccine developers with the goal of heading into the manufacturing phase. Manufacturing Vaccines, Pragmatic Issues, Challenges and Solutions, Aug 21, 2007 Cambridge MA

Bibliography
Bioprocess International, Glossary of Terms, 2006  http://www.bioprocessintl.com/default.asp?page=glossary 
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