SCOPE NOTE: Bioprocessing includes cell culture, protein expression, protein production, protein purification, contract manufacturing, CMC Chemistry manufacturing and controls, upstream and downstream processing, analytical development and quality, formulation and stability, cell and gene therapy production, and manufacturing. 

Related glossaries include Biologics   Cell & tissue technologies  Drug delivery & formulation   Protein technologies

Bioprocessing Summit Europe  March 24-26, 2020  Lisboa Portugal Program |  Upstream processing, Downstream processing, Cell and Gene therapy CMC and Manufacturing

Advances in Recovery and Purification  March 19-21, 2019  Lisboa, Portugal  Program |    As product pipelines diversify from traditional mAbs, downstream processing teams are under increasing pressure to develop new recovery and purification platforms, while at the same time, continue to reduce timelines, costs and minimize bottlenecks for traditional mAbs therapies.
Bioproduction: Scale, Bioreactors and Disposables  March 19-21, 2019  Lisboa, Portugal Program |     reviews the finesse required to manufacture biologics including scale-down models, scaling up production, engineering bioreactors, single-use systems, and ensuring quality, within the context of increasing productivity, while ensuring safety and achieving reduced costs. A holistic review of bioprocessing will be explored, as well as practical details, such as monitoring and analyzing processes, and examining in detail how bioreactors process cells and how to keep those cells happy.
Continuous Processing for Biopharmaceuticals March 19-20, 2019 Lisboa, Portugal Program |   Continuous processing has proven to reduce manufacturing costs and increase efficiencies, but what are the practical considerations when implementing this technology at scale? Which technology gaps still remain, how can companies ensure process control and stability, and where should companies be focusing resources and investments to ensure clinical and commercial success?
Optimising Cell Culture Technology  March 19-20, 2019  Lisboa, Portugal  Program |    The ubiquitous task of culturing cells is recognised as an established technology; yet, meeting the demands of industry pushes the need to increase titre, and decrease the time and resources necessary to meet project goals. CRISPR, modeling and computational insights will be discussed in the continuing efforts to improve yield.  

analytical development: Accelerating Analytical Development Optimizing the Speed and Efficiency of Key Analytical Steps in Biotherapeutic Development August 12-16, 2019 BOSTON MA Research for this meeting revealed that industry analytical groups are facing increased pressure to deliver key analytical studies used in candidate selection, process development, clinical development and regulatory submissions faster than ever before – and at lower costs. Accelerating Analytical Development offers a best practices forum in which industry scientists and managers can exchange ideas on strategies, new technologies and the integration of analytical methods in support of these goals. The conference will address the most important roles of the analytical function at every stage of development and provide insights on how different organizations are addressing these challenges  http://www.bioprocessingsummit.com/Preclinical-Analytical-Development/

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

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 http://www.nist.gov/tip/wp/upload/manufacturing_biomanufacturing_wp_08_11.pdf

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

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

Bioprocess Data Management January 20-21, 2020 • San Diego, CA The biopharmaceutical industry is meeting increasing demands and costs for biotherapeutics through process optimization. Advanced instrumentation with sampling techniques, new sensor technologies and analyzers have emerged to monitor both upstream and downstream processes. When well-prepared and analyzed, this data leads to process knowledge, process control, and continuous improvement resulting in greater speed, quality, and economy … addresses statistical analysis strategies including multivariate data analysis (MVDA), quality by design (QbD), process analytical technology (PAT), and multi-attribute method (MAM), allowing for optimized and informed control of bioprocessing.

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

bioprocessing:  The Bioprocessing Summit August 12-16, 2019 • Boston, MA upstream and downstream processing, analytical development and quality, formulation and stability, cell and gene therapy production and manufacturing.

Bioproduction: Scale, Bioreactors & Disposables Making It Work August 14-15, 2019 BOSTON MA reviews the finesse required to manufacture biologics including scale-down models, scaling up production, engineering bioreactors, single-use systems, and ensuring quality within the context of increasing productivity; while ensuring safety and achieving reduced costs.  A holistic review of bioprocessing will be explored, as well as practical details, such as monitoring and analyzing processes, and examining in detail how bioreactors process cells and how to keep those cells happy.  The conference will address robust production processes and next-generation technologies, while improving manufacturing platforms and ensuring product quality.. http://www.bioprocessingsummit.com/Bioproduction/

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: Regulatory  

 Biotherapeutics Analytical Summit  June 1-5, 2020• Alexandria VA Program |  Method Development, Qualification & Validation, Advances in Characterization Methods & Approaches and Comparability & Biosimilarity


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:  Optimizing Cell Culture Technology Enhancing Knowledge for Growing Cells  August 12-13, 2019   Boston, MA  Program |   By focusing solely on culturing cells, “Optimizing Cell Culture Technology” has long become the established ‘must attend’ international conference for keeping up with emerging trends and technologies that lead to improved qualities and higher titers. The conference examines breakthrough strategies and technologies for improving cell cultivation, including genome engineering and next-gen analyses and techniques, such as developing cell culture models. Industry experts provide insights into optimizing conditions as well as cell biology in the effort to improve yield, while also addressing the future of cell culture in an expanding market where demand continues to  increase.

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

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

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

cell line development: Optimizing Cell Line Development Enhancing Expression August 15-16, 2019 Boston MA  Cell Line Development has reached a new plateau influenced by genomic research and insights, along with emerging technologies that are pushing cell engineering into an uncharted future. The “Optimizing Cell Line Development” conference brings together cell line development experts who are forging this new era. They will share how to best optimize codons, construct vectors, and how to select and engineer clones and host systems, while maintaining stability and consistency. The conference will also focus on genomic research for CHO and other systems, as well as glycoengineering, systems biology, assays, and pathway delineation. In addition, challenges for introducing new technologies will be discussed, along with an overview of industrial trends and regulatory perspectives. http://www.bioprocessingsummit.com/Cell-Line-Development/

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

Cell Therapy CMC and Analytics August 12-13, 2019 BOSTON MA To ensure the quality, safety and rapid production of cell therapies, companies must keep on top of their CMC and analytical strategies. However, cell-based therapies are extremely complex to analysis with high variability. Cambridge Healthtech Institute’s Cell Therapy CMC and Analytics meeting focuses on the technical and regulatory requirements needed to advance the analysis, quality and development of cell therapies with in-depth case studies and regulatory feedback on CMC development, product release, assay development and validation, flow cytometry, target product profiles, critical quality attributes, critical process parameters, and product release.  http://www.bioprocessingsummit.com/Cell-Therapy-CMC/   See also CMC Chemistry

Cell Therapy Manufacturing Commercializing Cell-Based Therapies August 14-15, 2019 BOSTON MA  The recent approvals of CAR T therapies Yescarta and Kymiriah represent a major breakthrough for the cell therapy industry. But how will we manufacture these products at scale? And what platforms, technologies and cell processes can we expect to see in the future? Do the answers lie in traditional biomanufacturing methods or custom-made processes?  CHI’s Cell Therapy Manufacturing meeting takes an in-depth look at the practical challenges of manufacturing autologous and allogenic cell therapies at scale, with dedicated sessions on cell processing, scalability, bioreactors, next-generation production technologies, automation, closed systems, supply chain and facility design. The meeting will feature extensive sessions on CAR-Ts, NK cells, TCRs and manufacturing CRISPR-based CAR Ts at scale.   
http://www.bioprocessingsummit.com/Cell-Therapy-Bioproduction/

cGMP current Good Manufacturing Practice: Facts about  https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps
See also GMP Good Manufacturing Practice

characterization methods: Advances in Characterization Methods & Approaches From proteins and antibodies to cell and gene therapies June 2-3, 2020 Alexandria VA As new biotherapeutic formats progress through development into the regulatory process, analytical characterization needs to be even more robust, adaptable and creative. These new modalities present challenges to analytical scientists in product and process development, CMC as well as regulatory agencies. https://www.biotherapeuticsanalyticalsummit.com/characterization

Characterization of Biotherapeutics Exploring the Analytical Challenges of Today’s Complex Biologics APRIL 8-9, 2019 BOSTON MA As new product formats progress through development and into the regulatory process, the role of analytical characterization is taking on new meaning. Very new modalities present challenges to both analytical scientists and regulatory agencies alike, and this steep learning curve requires a near-constant cycle of adaptation and innovation.  The agencies are requiring sponsors to provide ever more complex data across a wide range of analytical methods, and instrumentation suppliers are striving to support this new era with unique product features, software and feature combinations.  https://www.pegsummit.com/Biotherapeutics-Characterization/

CHO cells Chinese Hamster Ovaries: Chinese hamster ovary (CHO) cells are the predominant cell factory for the production of biotherapeutics.  January 16-17, 2019 • San Diego, CA  | CHO cells’ rapid rise in production prominence is due to their adaptability to various culture conditions, gene plasticity, and ability in proper folding, posttranslational modifications, and glycosylation of desired proteins. Thus, advances in CHO cell lines and culture continue to significantly improve biotherapeutic production. This achievement is due to progress in engineering stable and transient cell lines, enhancing cell culture conditions and performance, as well as optimizing process development. When all are  accomplished, higher-production titers and better product quality result.http://www.chi-peptalk.com/cho-cells/  Broader term: mammalian cell culture

Comparability & Biosimilarity June 4-5, 2020 • Alexandria VA | explores the dynamic advances in analytical technologies, from novel approaches such as machine learning and data analytics, to cutting-edge technologies such as MS, MAM, NMR for characterization, as well as best practices for comparability and analytical similarity assessments, with the goal of determining a product's robustness, stability, safety, and consistency. https://www.biotherapeuticsanalyticalsummit.com/Comparability/

Continuous Processing in Biopharm Manufacturing Enabling Technologies & Creative Approaches August 12-13, 2019 BOSTON MA Whether you have implemented it, or are considering it in one way or another, continuous processing has become a household word among biopharma companies. Continuous manufacturing has the potential to increase the efficiency, flexibility, agility and robustness of manufacturing by reducing the number of steps and holds, utilizing smaller equipment and facilities, improving product quality and enabling real-time release. http://www.bioprocessingsummit.com/continuous-processing/

contract manufacturing: Production of goods by one firm, under the label or brand of another firm. Contract manufacturers provide such service to several (even competing) firms based on their own or the customers' designs, formulas, and/or specifications. Also called private label manufacturing. Business Dictionary http://www.businessdictionary.com/definition/contract-manufacturing.html

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

Digital BioManufacturing August 14-15 , 2019 BOSTON MA Industry 4.0, internet of things, big data, AI … these are words that we are seeing and hearing around us, enabling exciting developments such as autonomous cars, smart factories and connected cities. This wave of transformation is coming to the biopharm industry, promising to revolutionize the way we approach biologics development to manufacturing.  http://www.bioprocessingsummit.com/manufacturing-efficiencies/

disposables: See Bioproduction scale bioreactors & disposables

display of antibodies Display of Antibodies  2019 April 8-9 Boston MA showcases innovation in discovery, design and engineering of biologics through molecular evolution using phage, yeast and other display methodologies. The proliferation of novel constructs is possible through methods to improve library design, pharmacological and biophysical properties to create drug molecules with greater potency, modes of action, target specificity and activity than previously achievable.    Related terms: phage display, yeast display

downstream processing: The downstream part of a bioprocess refers to the part where the cell mass from the upstream are processed to meet purity and quality requirements. Downstream processing is usually divided into three main sections: cell disruption, a purification section and a polishing section. Wikipedia bioprocessing accessed 2018 Aug 17 https://en.wikipedia.org/wiki/Bioprocess   See related upstream processing

dynamic light scattering: a technique in physics that can be used to determine the size distribution profile of small particles in suspension or polymers in solution.^[1] In the scope of DLS, temporal fluctuations are usually analyzed by means of the intensity or photon auto-correlation function (also known as photon correlation spectroscopy or quasi-elastic light scattering). In the time domain analysis, the autocorrelation function (ACF) usually decays starting from zero delay time, and faster dynamics due to smaller particles lead to faster decorrelation of scattered intensity trace. It has been shown that the intensity ACF is the Fourier transformation of the power spectrum, and therefore the DLS measurements can be equally well performed in the spectral domain.^[2][3] DLS can also be used to probe the behavior of complex fluids such as concentrated polymer solutions. Wikipedia   https://en.wikipedia.org/wiki/Dynamic_light_scattering

expression vector: An expression vector, otherwise known as an expression construct, is usually a plasmid or virus designed for gene expression in cells. The vector is used to introduce a specific gene into a target cell, and can commandeer the cell's mechanism for protein synthesis to produce the protein encoded by the gene. Expression vectors are the basic tools in biotechnology for the production of proteins. Wikipedia accessed 2018 Aug 22 https://en.wikipedia.org/wiki/Expression_vector

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 

freeze drying See lyophilization

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

Gene Therapy CMC and Manufacturing 20-21 MARCH 2019 Lisbon Portugal  Lisboa Program  The vector-based gene therapy industry has undergone rapid advances over the last twelve months and shows no sign of slowing down. The clinical results are beyond encouraging. However, the pressure is now on CMC, analytical, process development and manufacturing department to produce these therapies at scale.   The Gene Therapy CMC and Bioproduction conference examines the practical challenges facing the production, characterization and quality control of vector-based gene therapies, with dedicated sessions on AAV and lentivirus-based platforms as well as oncolytic viruses, CRISPR and other gene editing therapies. Topics include new and emerging analytical strategies, upcoming regulations and the latest manufacturing strategies for large- and small-scale production.  See also CMC Chemistry

Gene therapy Bioprocessing Summit stream 2019 August 14-16 The Gene Therapy CMC and Manufacturing stream features two back-to-back conferences focusing on the critical challenges facing the analysis, characterization, quality control and manufacture of viral vector-based gene therapies. Examples come from both AAV and lentivirus-based therapies. Topics include impurity analysis, potency assay development, process development, scale-up, clinical and commercial manufacturing, purification and formulation.
http://www.bioprocessingsummit.com/stream/gene-therapy/

Gene Therapy CMC and Analytics August 14-15, 2019 BOSTON MA  Gene therapy is an extremely promising technique for the treatment of incurable diseases such as cancer and genetic disorders such as hemophilia. However, the analysis, characterization and delivery of these unique products remain an issue. Cambridge Healthtech Institute’s Gene Therapy CMC and Analytics meeting uncovers the practical challenges facing vector-based gene therapy analytics, assay development, quality control, vector development and delivery. http://www.bioprocessingsummit.com/gene-therapy-cmc/

Gene Therapy Manufacturing August 15-16, 2019 BOSTON MA  It is an exciting time for gene therapy – therapies on the market, encouraging clinical data and a long list of pharma collaborations. Pricing and reimbursement takes a majority of the headlines but equally important is producing these therapies in a scalable, cost-effective and robust way, all the while developing a clear CMC and characterization profile that satisfies the regulators. Cambridge Healthtech Institute’s Gene Therapy Manufacturing meeting takes a practical, case study driven approach to the process development, scale-up and production of gene therapies, tackling key topics such as AAV, lentivirus and retrovirus process development and scale-up, CMO management from early to late-stage development.  http://www.bioprocessingsummit.com/gene-therapy-bioproduction/

genes & vectors: Engineering Genes, Vectors, Constructs, and Clones Exploring Strategies in Systems Engineering and Synthetic Biology  JAN 20-21, 2020  San Diego CA The demand for high-quality biotherapeutic proteins has never been greater. Many variables still must be considered during the engineering process, including verification and sequence analysis of the gene or protein of interest, codon optimization, vector construction and clone/host selection – a time-consuming and expensive process. Additionally, protein expression scientists are now exploring new engineering tools including synthetic biology and systems engineering. Ultimately, these tools must be weighed against traditional expression and production strategies to achieve the desired quantity and quality. https://www.chi-peptalk.com/genes-vectors-clones/  

Good Manufacturing Practice: Wikipedia  http://en.wikipedia.org/wiki/Good_Manufacturing_Practice  Broader term: GxP

Host Cell Proteins Detection, Analysis and Control August 12-13, 2019 BOSTON MA A critical part of bioprocessing is the control of process-related impurities such as host cell proteins (HCPs), which co-purify with the drug substance and can cause adverse effects such as immunogenicity. Analytical methods are available but coverage and specificity is limited. Moreover, the emergence of new expression systems, new products and new techniques such as mass spectrometry has further compounded these limitations with regulators now pressing companies for more HCP data. CHI’s Host Cell Proteins conference brings together industry leaders to discuss critical HCP topics such as: risk assessment and control strategies, HCP characterization, assay coverage, critical reagents and platforming, plus questions relating to biosimilars, in-process testing and the latest data supporting the link between HCPs and immunogenicity.  http://www.bioprocessingsummit.com/Host-Cell-Proteins/

Industrial enzymes: enzymes that are commercially used in a variety of industries such as pharmaceuticals, chemical production, biofuels, food & beverage, and consumer products. Due to advancements in recent years, biocatalysis through isolated enzymes is considered more economical than use of whole cells. Enzymes may be used as a unit operation within a process to generate a desired product, or may be the product of interest. Industrial biological catalysis through enzymes has experienced rapid growth in recent years due to their ability to operate at mild conditions, and exceptional chiral and positional specificity, things that traditional chemical processes lack.[1]   Wikipedia accessed 2019 Jan 21 https://en.wikipedia.org/wiki/Industrial_enzymes

Lyophilization and Emerging Drying Technologies January 20-21, 2020 • San Diego, CA  the latest trends and challenges in lyophilization and emerging drying technologies. This conference featured in-depth case studies, new and unpublished data and discussions on developing scientifically sound freeze dried formulation, process optimization for biologics and vaccines. It will also present cutting edge research and case studies on freeze/thaw and formulation challenges, drying in cartridges, storage stability, QbD and PAT approaches and strategies for scale-up from R&D scale to full production level, and selection of container closure systems.  https://www.chi-peptalk.com/lyophilization-drying-technologies

Lyophilization includes spray drying, foam drying

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

mammalian cell culture: Biological products produced by recombinant DNA (rDNA) technology in animal cell cultures include enzymes, synthetic hormones, immunobiologicals (monoclonal antibodies, interleukins, lymphokines), and anticancer agents. Although many simpler proteins can be produced using rDNA in bacterial cultures, more complex proteins that are glycosylated (carbohydrate-modified) currently must be made in animal cells. …. The cost of growing mammalian cell cultures is high, so research is underway to produce such complex proteins in insect cells or in higher plants, use of single embryonic cell and somatic embryos as a source for direct gene transfer via particle bombardment, transit gene expression and confocal microscopy observation is one of its applications.  Wikipedia accessed 2018 Nov  18 https://en.wikipedia.org/wiki/Cell_culture#Concepts_in_mammalian_cell_culture  Narrower term: Chinese Hamster Ovary CHO cells

Method Development, Qualification & Validation Developing Fit-for-Purpose Methods throughout the Product Lifecycle MARCH 4-5, 2019 Alexandria VA From method development and qualification to validation and transfer, it is a continuous yet interdependent process from early R&D to QC and release; the objective is to prove that methods selected are fit for their intended purpose. With an expanded portfolio of newer formats and non-mAbs in the pipelines, knowledge, experience and advanced techniques are critical to establish efficient, accurate and fit-for-purpose analytical methods that can be subsequently qualified, validated and transferred to release testing, thereby improving efficiency and reducing cost, time and resources. http://www.biotherapeuticsanalyticalsummit.com/Method-Development-Validation

Microbial Production January 17-18, 2019 • San Diego, CA  http://www.chi-peptalk.com/microbial-production-conference/   Microbial expression systems offer significant advantages over other hosts by providing faster development times, greater yields, lower production costs, particularly in E. coli which is one of the most widely used hosts for protein production. However, limitations around glycosylation and central metabolic pathways poses significant challenges… covered the latest developments in microbial expression and production – from host strain development to metabolic engineering, assembly to scale-up, downstream processing to potential aggregation – with particular focus on the role of E. coli for biotherapeutics, novel products and other industrial applications.

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

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

Oligonucleotide CMC & Regulatory Boston  March 26-28, 2019 Cambridge, MA  Program |  sessions on new chemistries, novel delivery mechanisms and the most important preclinical and clinical advances. Leading oligonucleotide scientists deliver detailed case studies on antisense, RNA, aptamer and oligonucleotide conjugates

PEGS: the essential protein engineering summit  May 4-8, 2020 • Boston, MA Program | Conference programs include protein and antibody engineering, cancer immunotherapy, oncology, and emerging therapeutics.

PEGS Europe  2019 Nov 18-22 Lisbon Portugal  Conference programs include Engineering, Oncology, Analytical, Immunotherapy, Expression and Bispecifics.

PepTalk  January 20-24, 2020 • San Diego, CA Program |  Conference programs include Protein Engineering and Development, Innovations in Discovery and Development, Antibody Therapeutics,  Formulation and Stability, Analytics & Impurities, Process Technologies & Purification, Biotherapeutic expression & production, Alternative expression & products.

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).    

Process Analytical Technology PAT:  The goal of PAT is to understand and control the manufacturing process, which is consistent with our current drug quality system: quality cannot be tested into products; it should be built-in or should be by design.  Process Analytical Technology is: 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.  OPS Process Analytical Technology - (PAT) Initiative  FDA, CDER, Office of Medical Products & Tobacco https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm088828.htm

Process Characterization and Control A best practices forum for the translation of process understanding into control strategies for maintaining quality throughout the product lifecycle August 15-16, 2019, BOSTON MA  With the recent publication of process validation guidances from both US and European regulators, the demonstration of process understanding, identification of critical quality attributes and the implementation of well-validated control strategies must now become a routine part of biologics manufacturing operations. But significant ambiguities remain in the specific steps that must be taken in the production of legacy and new products, by companies of different scale and resources and for specific product formats. http://www.bioprocessingsummit.com/Process-Characterization/

process chemistry:  To compile a list of terms with their definitions  https://iupac.org/projects/project-details/?project_nr=2001-049-2-700  Glossary of terms used in Process Chemistry/Manufacturing of Active Pharmaceutical Ingredients” and “Pharmaceutics work in progress.

protein expression: Optimizing Protein Expression Enhancing Expression Systems APRIL 10-11, 2019 BOSTON MA  Expression of heterologous proteins presents many challenges and understanding expression systems is key. The 9^th annual Optimizing Protein Expression conference delves into protein expression by examining and enhancing expression systems, including CHO and other mammalian systems, E. coli, yeast and baculovirus. What is the best expression system for expressing your protein of choice? Ease and cost of scale-up must be considered to ensure successful bottom-line results. Experts will share case studies and disclose data while divulging details of expression systems’ underlying mechanisms. Comparing and contrasting systems will also be featured to increase understanding in the quest for greater productivity.  Program | .See also Expression gene & protein

protein expression difficult:  Difficult-to-Express Proteins Overcoming Expression Challenges  APRIL 8-9, 2019 Boston MA Proteins are each unique and bring unique challenges when attempting to tame them into submission. This conference examines the challenges researchers encounter when striving for high-yield production of “difficult-to-express” proteins (DTEPs) and the strategies and technologies that have proven successful in overcoming those challenges. Some of the difficulties encountered include solubility, proper folding, inability to crystallize and aggregation and formation of inclusion bodies. Researchers employ a range of problem-specific solutions to achieve expression including genetic modifications, manipulating how a target protein is produced and employing protein tags. In addition, the identification of DNA coding sequences along with the use of high-throughput approaches has brought about significant improvements. Program

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 Purification and Recovery January 21-22 , 2020 • San Diego, CA | In the world of biologics, purifying protein remains a constant bottleneck and nagging headache. A process that works great for one protein, may not work at all for the next. Not only are the tasks challenging, but outcomes must be ensured to result in properly folded protein. CHI’s Protein Purification and Recovery conference examines the strategies that efficiently lead to pure protein for research or therapeutic use. This leading conference illustrates how ‘traditional’ strategies (protein A, chromatography, affinity tags) are being innovated and improved, while also demonstrating the new technologies that are being introduced and integrated to help streamline purification while ensuring quality. This conference will also explore the finesse required when purifying complex molecules, such as membrane proteins, bispecifics and antibody-drug conjugates, in the ever-present quest for purity.  https://www.chi-peptalk.com/protein-purification


Recombinant Protein Expression and Production January 21-22, 2020 • San Diego, CA Program | Biopharmaceuticals currently represent the fastest-growing sector of the pharmaceutical industry, driven by a rapid expansion in the manufacture of recombinant protein-based drugs. Great strides have been made in the expression, production, and purification of biotherapeutics. However, hurdles remain. The efficient expression and production of these valuable biomolecules face challenges in improving their quantity and quality while minimizing time and cost. Thus, higher-throughput expression and purification as well as more flexible expression platforms are in even greater demand. Unfortunately, there is no “universal” production system which can guarantee high yields of recombinant protein, particularly as every biomolecule itself causes its own issues in terms of expression. https://www.chi-peptalk.com/protein-expression-production