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 Pharmaceutical bioprocessing & manufacturing glossary & taxonomy
Evolving Terminologies for Emerging Technologies
Comments? Questions? Revisions?  Mary Chitty 
mchitty@healthtech.com
Last revised December 20, 2011
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PEGS: the essential protein engineering summit  April 30 - May 4, 2012 • Boston, MA Program | Register | Download Brochure
PEGS: the essential protein engineering summit
PEGS Europe - Protein & Antibody Engineering Summit
 October 11-13, 2011 • Hannover Germany Program | Register | Download Brochure  
PEGS Europe - Protein & Antibody Engineering Summit

affinity protein purification: One of the more efficient methods to enrich or purify a protein from other proteins and components in a crude cell lysate or other samples is affinity purification, whereby the protein of interest is purified by taking advantage of it’s specific binding properties to an immobilized ligand.  It is important to select the optimal affinity purification  method for your purification project. To maintain a competitive advantage, it is important to address issues such as fusion tags, support for affinity purification, quality and  efficiency. Affinity Protein Purification August 22-23, 2011 • Boston, MA Program | Register | Download Brochure  


Affinity Tags for Protein Purification DVD May 20, 2010  Overview of affinity tags along with a case study of developing tandem affinity purification (TAP)-mass spectrometry approaches to protein purification.

analytical characterization: See characterization analytical  Related term sample prep

antibody purification: Antibodies have become a mainstay of biological research and therapies. As their use has spread, their designs have become both more elaborate and smaller. This meeting explores the often challenging but necessary task of purifying antibodies and antibody fragments. Purifying antibodies from transgenic sources will also be discussed along with recommended uses for robotics and automation. Purifying Antibodies May 12-13, 2011 • Boston, MA Program | Register | Download Brochure  PEGS: the essential protein engineering summit  

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: Baculovirus vectors are widely used as tools for expressing proteins, delivering genes into cells, and creating vaccines.  Once viewed as an alternative, the baculovirus system has achieved recognition through extensive clinical testing and regulatory exposure.  The speed of reaching protein expression and the inability to transmit mammalian disease makes baculovirus an attractive platform. Baculovirus Technology August 24-25, 2011 • Boston, MA Program | Register | Download Brochure 

BioAnalytical Summit
BioAnalytical Summit  March 19-22, 2012 • Bethesda, MD Program | Register | Download Brochure



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 

Biomarker Breakthroughs: Manufacturing http://www.biomarkerbreakthroughs.com/category/100/manufacturing/ 

biopreservation: The increasing demand for recombinant therapeutic proteins has placed pressure on the biopharmaceutical industry.   Thus, considerable resources are used to develop high-yielding cell line production systems. Preserving these cell lines for optimum yield, viability, and productivity is not that simple. Cell banking systems maintain that a uniform population of cells is preserved and that their integrity is sustained. However, assuming that the same principles of biopreservation apply to all cell lines is a common misunderstanding. Biopreservation August 22-23, 2011 • Boston, MA Program | Register | Download Brochure

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 Summit  August 22-25, 2011 • Boston, MA Program | Register | Download Brochure The Bioprocessing Summit

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

Scaling Up & Down With Optimized Bioreactors + Disposables  This meeting addresses how to achieve greater productivity as growth transitions through differing scale en route to reaching optimized processes for producing biologics.  Besides exploring strategies for scaling production, the meeting will review ongoing innovations for bioreactor protocols and design, and will take a look at single-use options.  In addition, we are building in a session highlighting CHO cells, while also reviewing other mammalian and microbial systems. Scaling Up & Down With Optimized Bioreactors & Disposables August 24-25, 2011  Boston, MA Program | Register | Download Brochure


biosimilars: Regulator
biotechnology: Biologics

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

This meeting will explore today’s evolving strategies and technologies for improving the robustness of mammalian cell cultivation, from media enhancement to providing the optimal culture conditions. Optimizing Cell Culture Technology August 22-23, 2011 • Boston, MAProgram | Register | Download Brochure  


Faster & easier cell culture using design of experiment DVD Feb 6 2011 http://www.healthtech.com/zocm 

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

characterization, analytical:  Advanced technologies for physicochemical and biological characterization for a range of complex therapeutic proteins to provide a fuller understanding of the product, to ensure safety and efficacy, and to facilitate smooth and efficient interaction with the regulatory authorities. It focuses on identification of hot spots for liability, characterization of impurities, and predictability of stress. There is a strong emphasis on case studies, practical application, technology transfer and fulfilling regulatory expectations.  Analytical Characterization April 4-5, 2011 • Bethesda, MD Program | Register | Download Brochure
 
Analytical Characterization
clone constructs & vectors:
The demand for high quality biotherapeutic proteins has never been greater, yet meeting this demand is challenging because protein expression is both an art and a science. Bottlenecks frequently arise because functional proteins are difficult to produce. 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, or re-characterizing the expressed protein —an inefficient, time-consuming and expensive process. Targeting Genes, Engineering Vectors, Designing Constructs & Optimizing Genes January 10-11, 2011 • Coronado, CA Program | Register | Download Brochure  Order CD Targeting Genes, Engineering Vectors, Designing Constructs & Optimizing Genes

comparability biologics: comparability strategies from leaders in the field for a range of therapeutic proteins with a strong emphasis on providing suitable data to the regulatory authorities to reduce difficulties and delays and to ensure safety and efficacy with every batch of drug. Characterization & Comparability for Biologics April 4-7, 2011 • Bethesda, MD Program | Register | Download Brochure 
Characterization & Comparability for Biologics
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 •  

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 

Good Manufacturing Practice:  http://www.fda.gov/cdrh/comp/gmp.html  
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

host expression: Great strides have been made in the expression of proteins for biotherapeutics; however, with these strides have come new hurdles. Higher-throughput expression and purification, as well as more flexible expression systems and techniques are in even greater demand now to support the needs of the research pipeline. This meeting explores the newest data and innovations relating to the expression and characterization of proteins for biological understanding and therapeutics, as well as strategies to make the eventual expression of these proteins more effective, efficient and trouble-free. Attention is given to new hosts and platforms, as well as how to select, engineer and optimize these hosts.  Choosing, Designing, and Optimizing Hosts and Platforms January 12-13, 2011 • Coronado, CA Program | Register | Download Brochure    Order CD
Choosing, Designing, and Optimizing Hosts and Platforms
 January 11-12, 2012 • Coronado, CA Program | Register | Download Brochure

Choosing, Designing, and Optimizing Hosts and Platforms

lyophilization:  Optimizing formulation, cycle development, compliance and scale-up. Lyophilization, Spray Drying & Emerging Drying Technologies January 12-13, 2011 • Coronado, CA Program | Register | Download Brochure Lyophilization, Spray Drying & Emerging Drying TechnologiesOrder CD

Lyophilization, Spray Drying & Emerging Drying Technologies January 12-13, 2012 • Coronado, CA Program | Register | Download Brochure

mammalian cell lines: Gene expression in mammalian cells is the foundation for protein production.  As more protein-based products head into development, the need to refine processes for optimizing cell line development increases.  Reducing the time needed to identify high-expressing clones and develop cell lines is essential for trimming a project’s overall costs. Optimizing Mammalian Cell Lines August 24-25, 2011 • Boston, MA Program | Register | Download Brochure


media - optimizing:
The cell culture medium is a dynamic mixture consisting of amino acids, vitamins, a source of energy, growth factors, trace minerals and other components in a buffered salt solution.  Each component has a shelf life, sensitivity to the physical environment and a variety of interactive and break-down products.  The Classical mammalian cell culture formulations require further supplementation with a protein source such as serum and were designed using cancer-derived cell lines.  Serum supplemented formulations for mammalian cells can be very sub-optimal for the growth of cells at high cell concentrations and for the isolation of recombinant products, antibodies or virus. Optimizing Media DVD August 24, 2009 • 

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

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.  Characterization and Analysis of Particulates DVD January 9, 2011 • 
PEGS: the essential protein engineering summit  April 30 - May 4, 2012 • Boston, MA Program | Register | Download Brochure
PEGS: the essential protein engineering summit 	PepTalk  January 9-13, 2012 • Coronado, CA Program | Register | Download Brochure    Order 2011 CD
PepTalk

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).   Google = about 10,600 Sept. 19, 2002; about 11,100 Sept. 16, 2004  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:
  The focus of this meeting will be case studies of successful routes of synthesis for drug substance/API. But the overarching theme will be how process chemists deal with the challenge of ‘fit for purpose’ process R&D. Can you have a process that is workable for early phase or pre-clinical supply demands that have short timelines while at the same time planning for more long term development strategies?   Current Process Chemistry  June 13-14, 2012 • Princeton, NJ Program | Register | Download Brochure
Current 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 development monoclonal antibodies: Program Management for Monoclonal Antibody Process Development & Manufacturing DVD

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 Order CD

protein aggregation: understanding and overcoming analytic, formulation, manufacturing and regulatory challenges Protein Aggregation and Emerging Analytical Tools January 13-14, 2011 • Coronado, CA Program | Register | Download Brochure  Order CD
Protein Aggregation and Emerging Analytical Tools January 12-13, 2012 • Coronado, CA Program  | Register | Download Brochure

Protein Aggregation and Emerging Analytical Tools  
The study and prevention of protein aggregation and its consequences represents one of the most demanding tasks in biomedical research and pharmaceutical manufacturing today. Protein aggregation & stability  PEGS: the essential protein engineering summit May 9-13, 2011 • Boston, MA Program | Register | Download Brochure  
 


protein characterization: Characterization, Purification & Screening”  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 | Download Brochure Order CD

protein expression: 
The discovery, development and production of therapeutic proteins is a crucial activity in the protein engineering field.  PepTalk's Pipeline Four provides the latest science and developments on topics covering all aspects of protein science, discovery, analysis, characterization, development and expression of these valuable and promising therapeutics.

Protein Expression: Overcoming Challenges with Solutions January 12-13, 2012 • Coronado, CA Program |  Register |  Download Brochure
Overcoming Protein Expression Challenges with Solutions

Protein Expression and Cell Line Development October 11-12, 2011 • Hannover Germany Program | Register | Download Brochure
Protein Expression and Cell Line Development  
Despite decades of research and advances, some areas of protein science remain extremely challenging and complex.  Antibodies, vaccines, human proteins, and other difficult-to-express proteins have fueled new research and expression methodologies and technologies.  High throughput purification and tags promise great rewards, but still pose important questions for researchers.  Cell free expression methods hold great potential, but pose new challenges. Overcoming Protein Expression Challenges with Solutions January 13-14, 2011 • Coronado, CA Program | Register | Download Brochure  Order CD      See also Expression gene & protein

protein expression difficult:  Difficult Protein Expression and Purification October 12-13, 2011 • Hannover Germany Program | Register | Download Brochure
Difficult Protein Expression and Purification  

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. This conference will present innovative and imaginative methods to make those difficult to express proteins more cooperative. Difficult to express proteins PEGS: the essential protein engineering summit May 9-13, 2011 • Boston, MA Program | Register | Download Brochure   Order CD

protein expression- optimizing: By focusing on expression systems, this meeting provides insights into real-world mechanisms for “Optimizing Protein Expression.” Experts in the different ‘primary’ systems – CHO/mammalian, baculovirus, e.coli, and yeast Optimizing protein expression PEGS: the essential protein engineering summit May 9-13, 2011 • 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:  Conquering proteins’ innate properties in order to achieve purified proteins will be addressed in Pipeline Two.  Beginning with ‘traditional’ protein purification, Pipeline Two will then examine the numerous challenges of high throughput processing encountered en route to a protein product.  Analytical tools and methods for detecting protein aggregation will be highlighted in the quest for solubility and manufacturability.  Taming proteins’ wild nature will be discussed throughout the week in an effort to understand biological activity and develop protein products that achieve project goals.    
Protein Purification and Recovery  January 9-10, 2012 • Coronado, CA Program | Register | Download Brochure
  
Higher Throughput Protein Purificat
ion January 11-12, 2012 • Coronado, CA Program | Register | Download Brochure
Higher Throughput Protein Purificaton



Current tactics and technologies for optimizing the task of purifying proteins in the effort to reach consistency and quality. Case studies are presented that are based on science, yet illustrate the tenacity needed to maximize purity and yield, while minimizing purification steps. Sessions highlight alternative expression systems, affinity tags, achieving higher throughput, and difficult-to-purify proteins. Protein Purification & Recovery January 10-11, 2011 • Coronado, CA Program | Register | Download Brochure  Order CD 

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 

sample preparation Pre-analytical processing is a pivotal part of clinical diagnostics. Its modernization should closely follow or even precede the emergence of new diagnostic technologies. Target enrichment as part of pre-analytical processing has the ability to significantly increase sensitivity and specificity of a test that is run on a heterogeneous sample or a sample that contains a low concentration of analyte. This conference is designed to demonstrate the latest advances in pre-analytical processing, sample preparation and target enrichment for clinical laboratory testing. ]Innovative Sample Prep and Target Enrichment in Clinical Diagnostics  April 18-19, 2012 • Newport Beach, CA Program | Register | Download Brochure
Innovative Sample Prep and Target Enrichment in Clinical Diagnostics

tissue culture: See cell culture. IUPAC Biotech

vaccine manufacturing:
With the advent of new vaccines for both infectious disease and therapeutic use, the challenge for the vaccine manufacturer is to increase productivity, maintain adherence to regulatory requirements and evaluate novel platforms and technologies to stay current. In addition to the technological advances of the field, the increased importance of both U.S. and international regulatory agencies will be addressed as well as the latest in FDA guidance documents and their impact on current production. Production & Manufacturing of Vaccines August 16-17 2011 • Cambridge, MA Program  



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 Series http://www.insightpharmareports.com/Reports/All.aspx?s=BPS    
Insight Pharma Reports  Therapeutic Protein Production: A Changing Landscape 2010
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
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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