Latest news with #Biologics
Yahoo
3 days ago
- Business
- Yahoo
FDA Process Validation for Pharmaceutical and Biologics Course (ONLINE EVENT: June 11-12, 2025)
This FDA Process Validation Training session is an interactive online seminar that can provide a channel to augment the understanding of the trainees regarding the Constant Process Verification, will be revised in detail. The training course includes all necessary information regarding where it begins; what it includes; and, when it ends. Process Validation for Pharmaceutical and Biologics Dublin, June 04, 2025 (GLOBE NEWSWIRE) -- The "Process Validation for Pharmaceutical and Biologics" training has been added to offering. This FDA Process Validation Training session is an interactive online seminar that can provide a channel to augment the understanding of the trainees regarding the Constant Process Verification, will be revised in detail. The training course includes all necessary information regarding where it begins; what it includes; and, when it ends. The Process Validation Guidelines (January 2011) and the EU Annex 15: Requirement and Authentication (October 2015) outline the overall values and methods the two controlling bodies reflect suitable elements of process validation for the production of human and animal drugs and biological foodstuffs, including Active Pharmaceutical Ingredients (APIs). This directive aligns Process Validation activities with a product life cycle concept and with existing FDA and EU guidance, including the FDA/International Conference on Harmonization (ICH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The life cycle concept, new to this Guidance, links creation and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. This supervision also cares for process development and novelty through sound science and risk management. The new Process Validation Guideline/Practice includes elements of Process Validation as early as the Research and Development phase, and continues onward through Technology Transfer, into the Phase 1 IND Clinical Trial manufacturing phase, and ultimately into Phases 2 and 3, and then commercial manufacturing. Some general questions asked by the users of FDA Process Validation Training Here are a few common questions that the trainees attending the FDA Process Validation Training must ask to upgrade their initial knowledge: How can one integrate these two different concepts (Phase-wise and stage-wise)? Where do they merge? Can they exist independently or can they complement each other to improve, figure, and deliver a product that neither alone could? To what extent, the users must use them? Does it follow along with Stage 3? Questions that exist include how one manages special situations including viral inactivation and removal, impurity clearance, process consistency, process solution stability, endotoxin, bioburden, and other miscellaneous cell culture tests including DNA and host cell protein. The experts for FDA Process Validation Training will address these questions in Stage 2 as presented here. It will include the utilization of Procedure Validation and Phase 1, 2, and 3, where their Guidance mixture and where remain distinct. In particular, Stage 3. Important: The seminar insists that the trainees attending the FDA Process Validation Training plan to bring a multidisciplinary cluster from your Establishment to get the most from this very important seminar. Objectives of Learning for FDA Process Validation Training: Why are these FDA Guidance/EU Guidelines for Industry-Process Validation so significant to the pharmacological and ergonomics industry? Where does the Process Validation commence? How does Stage 1 integrate with Phase 1? What FDA sections are composed and omitted within the "NEW" Process Validation? What are the Three Stages and Where Do They Apply within the NEW Process Validation? The Authentication approaches are included within this Guidance document. The Constitutional and Supervisory Requirements for Procedure Endorsement. An Outline to Phase 1 Guidance for Industry and Its Application within the "NEW" Process Validation. The Phase 1 Untried Drug Requirements -- What is and What is NOT Required? General Considerations for Process Validation - Stage 2 Process Qualification. Regulatory Strategies for Phases 2 and 3 and their Incorporation within Stages 1 and 2. General Considerations for Process Validation - Stage 3 Continued Process Verification. An Appraisal of EU Annex 15 and its Comparison to FDA's Process Validation Direction. Who Should Attend: Quality Control Project Management Quality Assurance Product Development Regulatory Compliance Product Development Industrial and Amenities specialists who need to grow and participate in developing understanding regarding the issues surrounding Method Endorsement. Key Topics Covered: Day 1 Overview, Goals and Objectives, Definitions. Process Validation - Its Importance within the Drug Industry What is included in the "New" Process Validation (PV) Guidance? The Constitutional and Supervisory Requirements for "PV" Interaction of the Three Stages with Procedure Validation General Considerations for 'PV" - Stage 1 Stage 2 - Phase 1. History and Controlling Basis Authentication Methods, cGMPs in Scientific Supply Manufacture, What's Included within Phase 1, Stage 2 A Review of Industrial Deliberations Special Industrial Situations within Phase 1 Multi-Product Amenities and their Organization Management of Organic and Biotechnology Amenities Management of Sterile Products/Aseptically Produced Products The Necessities of Phase 1 Investigational Medication Necessities How does One Understand and Utilize Them? Regulatory Strategies for Phases 2 and 3 and their Incorporation within Stages 1 and 2 Operation of Procedure Design to Regulate its Duplicability Competences Organization of Amenities, Apparatus, and Values Requirement Day 2 General Deliberations for Procedure Authentication - Stage 2 Process Qualifications Requirement of Values and Gear Expansion of Ecological or Conservational Monitoring Development of Amenities Project Water Systems Development Special Deliberations for Procedure Authentication - Stage 2 Appraisal of Special Study Protocols Studying the Special Requirements of Phase 2/3 Stage 2 Overall Considerations for Process Validation - Stage 3 Sustained Process Corroboration Promising Continued Process Confirmation Remains in Control Use of Cautionary Letters as Instances A Review of EU Annex 15 and its Comparison to FDA's Process Validation Guidance A Demonstration of Similarity Between the Two Simultaneous Issue of Process Presentation Qualification (PPQ) Batches Rationalizes Why it Requires being Accompanied by a Systematic Critical Overview Must be evaluated for Stability Program Inclusion Analytical Methodology and Process Validation Discusses the Need for Accurate and Precise Monitoring Techniques Why are the Development Validated Methods necessary? Speakers: Barry A. Friedman, Ph.D Consultant Cambrex Bio Sciences Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology. Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international. Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n' Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide. Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology. For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment Process Validation for Pharmaceutical and Biologics CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
Yahoo
3 days ago
- Business
- Yahoo
FDA Process Validation for Pharmaceutical and Biologics Course (ONLINE EVENT: June 11-12, 2025)
This FDA Process Validation Training session is an interactive online seminar that can provide a channel to augment the understanding of the trainees regarding the Constant Process Verification, will be revised in detail. The training course includes all necessary information regarding where it begins; what it includes; and, when it ends. Process Validation for Pharmaceutical and Biologics Dublin, June 04, 2025 (GLOBE NEWSWIRE) -- The "Process Validation for Pharmaceutical and Biologics" training has been added to offering. This FDA Process Validation Training session is an interactive online seminar that can provide a channel to augment the understanding of the trainees regarding the Constant Process Verification, will be revised in detail. The training course includes all necessary information regarding where it begins; what it includes; and, when it ends. The Process Validation Guidelines (January 2011) and the EU Annex 15: Requirement and Authentication (October 2015) outline the overall values and methods the two controlling bodies reflect suitable elements of process validation for the production of human and animal drugs and biological foodstuffs, including Active Pharmaceutical Ingredients (APIs). This directive aligns Process Validation activities with a product life cycle concept and with existing FDA and EU guidance, including the FDA/International Conference on Harmonization (ICH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The life cycle concept, new to this Guidance, links creation and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. This supervision also cares for process development and novelty through sound science and risk management. The new Process Validation Guideline/Practice includes elements of Process Validation as early as the Research and Development phase, and continues onward through Technology Transfer, into the Phase 1 IND Clinical Trial manufacturing phase, and ultimately into Phases 2 and 3, and then commercial manufacturing. Some general questions asked by the users of FDA Process Validation Training Here are a few common questions that the trainees attending the FDA Process Validation Training must ask to upgrade their initial knowledge: How can one integrate these two different concepts (Phase-wise and stage-wise)? Where do they merge? Can they exist independently or can they complement each other to improve, figure, and deliver a product that neither alone could? To what extent, the users must use them? Does it follow along with Stage 3? Questions that exist include how one manages special situations including viral inactivation and removal, impurity clearance, process consistency, process solution stability, endotoxin, bioburden, and other miscellaneous cell culture tests including DNA and host cell protein. The experts for FDA Process Validation Training will address these questions in Stage 2 as presented here. It will include the utilization of Procedure Validation and Phase 1, 2, and 3, where their Guidance mixture and where remain distinct. In particular, Stage 3. Important: The seminar insists that the trainees attending the FDA Process Validation Training plan to bring a multidisciplinary cluster from your Establishment to get the most from this very important seminar. Objectives of Learning for FDA Process Validation Training: Why are these FDA Guidance/EU Guidelines for Industry-Process Validation so significant to the pharmacological and ergonomics industry? Where does the Process Validation commence? How does Stage 1 integrate with Phase 1? What FDA sections are composed and omitted within the "NEW" Process Validation? What are the Three Stages and Where Do They Apply within the NEW Process Validation? The Authentication approaches are included within this Guidance document. The Constitutional and Supervisory Requirements for Procedure Endorsement. An Outline to Phase 1 Guidance for Industry and Its Application within the "NEW" Process Validation. The Phase 1 Untried Drug Requirements -- What is and What is NOT Required? General Considerations for Process Validation - Stage 2 Process Qualification. Regulatory Strategies for Phases 2 and 3 and their Incorporation within Stages 1 and 2. General Considerations for Process Validation - Stage 3 Continued Process Verification. An Appraisal of EU Annex 15 and its Comparison to FDA's Process Validation Direction. Who Should Attend: Quality Control Project Management Quality Assurance Product Development Regulatory Compliance Product Development Industrial and Amenities specialists who need to grow and participate in developing understanding regarding the issues surrounding Method Endorsement. Key Topics Covered: Day 1 Overview, Goals and Objectives, Definitions. Process Validation - Its Importance within the Drug Industry What is included in the "New" Process Validation (PV) Guidance? The Constitutional and Supervisory Requirements for "PV" Interaction of the Three Stages with Procedure Validation General Considerations for 'PV" - Stage 1 Stage 2 - Phase 1. History and Controlling Basis Authentication Methods, cGMPs in Scientific Supply Manufacture, What's Included within Phase 1, Stage 2 A Review of Industrial Deliberations Special Industrial Situations within Phase 1 Multi-Product Amenities and their Organization Management of Organic and Biotechnology Amenities Management of Sterile Products/Aseptically Produced Products The Necessities of Phase 1 Investigational Medication Necessities How does One Understand and Utilize Them? Regulatory Strategies for Phases 2 and 3 and their Incorporation within Stages 1 and 2 Operation of Procedure Design to Regulate its Duplicability Competences Organization of Amenities, Apparatus, and Values Requirement Day 2 General Deliberations for Procedure Authentication - Stage 2 Process Qualifications Requirement of Values and Gear Expansion of Ecological or Conservational Monitoring Development of Amenities Project Water Systems Development Special Deliberations for Procedure Authentication - Stage 2 Appraisal of Special Study Protocols Studying the Special Requirements of Phase 2/3 Stage 2 Overall Considerations for Process Validation - Stage 3 Sustained Process Corroboration Promising Continued Process Confirmation Remains in Control Use of Cautionary Letters as Instances A Review of EU Annex 15 and its Comparison to FDA's Process Validation Guidance A Demonstration of Similarity Between the Two Simultaneous Issue of Process Presentation Qualification (PPQ) Batches Rationalizes Why it Requires being Accompanied by a Systematic Critical Overview Must be evaluated for Stability Program Inclusion Analytical Methodology and Process Validation Discusses the Need for Accurate and Precise Monitoring Techniques Why are the Development Validated Methods necessary? Speakers: Barry A. Friedman, Ph.D Consultant Cambrex Bio Sciences Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology. Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international. Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n' Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide. Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology. For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment Process Validation for Pharmaceutical and Biologics CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
16-05-2025
- Business
- Globe and Mail
Protein Expression Market to Hit USD 4.82 Billion by 2029 with 7.1% CAGR
Browse 632 market data Tables and 71 Figures spread through 470 Pages and in-depth TOC on "Protein Expression Market by Product (Reagents, Vectors, Competent Cells, Instruments, Software), Services, System Type (Mammalian (CHO, HEK293), Insect, Yeast), Workflow, Application (Therapeutic, Research, Industrial) - Global Forecast to 2029 The global protein expression market growth forecasted to transform from USD 3.41 billion in 2024 to USD 4.82 billion by 2029, driven by a CAGR of 7.1%. Factors such as the rise in R&D within the pharmaceutical and biopharmaceutical industries owing to the increasing demand for biologics and the growing use of artificial intelligence and machine learning to enhance protein expression workflow, drive the growth of the protein expression market. Other factors such as the growing clinical activities outsourcing trend and an increasing shift toward personalized medicines support the growth of the protein expression market. Furthermore, advancements in synthetic protein production technologies and the growing use of recombinant proteins provide growth opportunities for companies operating in the protein expression market. However, the high cost of protein expression offerings and the dominance of small molecules in drug development are expected to restrain the growth of this market to a certain extent. Browse in-depth TOC on 'Protein Expression Market' 632 - Tables 71 - Figures 470 - Pages Based on system type, the protein expression market is segmented into mammalian cell expression systems, prokaryotic expression systems, cell-free expression systems, yeast expression systems, insect cell expression systems, and algal-based expression systems. In 2023, the mammalian cell expression systems segment held the largest share of the global protein expression market, owing to the preference given to these systems to produce complex proteins such as monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), and vaccines. Among these systems, Chinese hamster ovary (CHO) cells are the most used due to their rapid growth and high protein expression capabilities. The protein expression market has been segmented based on application into three segments, including industrial application, research application, and therapeutic applications. In 2023, the therapeutic application segment had the highest market share across the protein expression market. This segment of the application is growing because of the increasing cases of chronic diseases like diabetes, cardiovascular diseases, and neurological disorders that are supporting the demand for protein-based therapies such as mAb and vaccines. Moreover, the segmental growth is further supported by the increased focus on the production of personalized medicine through grants and funding support. Based on offerings, the protein expression market is segmented into products and services. The products are segmented further into expression vectors, competent cells, reagents & kits, instruments, and software. In 2023, the protein expression market was dominated by the products segment. This large share can be attributed to the growing research alongside the rising approvals and commercialization of biologics, for example, antibodies. The reagents & kits sub-segment held the majority share under the products segment since the demand for reagents & kits persists in the sphere of research. This is because they need to be refilled periodically throughout the process of protein expression. Moreover, companies are launching innovative products for advanced protein expression workflows further supporting the growth prospects for the products segment. Based on end users of protein expression products, the protein expression market is segmented into contract research organizations & contract development and manufacturing organizations (CROS and CDMOs), pharmaceutical and biotechnology companies, and academic & research institutes, and other end users. In 2023, the pharmaceutical and biotechnology companies held the largest share of the global protein expression product market, and this growth trend is expected to continue during the forecast period. The large share of this end-user segment is supported by the increase in the demand for therapeutic proteins and the rising approvals for recombinant therapeutic proteins for disease treatment. The protein expression market is segmented into North America, Europe, Asia Pacific, Latin America, the Middle East, and Africa based on region. In 2023, North America held the largest share of the protein expression market, followed by Europe. The presence of major suppliers and key end users for the protein expression offerings in the region supports the large share of the North American protein expression market. Other drivers include growth in the biotechnology and pharmaceuticals industries, the growing prevalence of chronic disorders, and investments in the research and development of protein-based therapeutics research that contribute to furthering this large share of this market. North America is expected to dominate this space during the forecast period. The protein expression market is highly consolidated. The top players in this market hold a significant share of the total market. Prominent market players include Thermo Fisher Scientific Inc. (US), Merck KGaA (Germany), Danaher Corporation (US), Sartorius AG (Germany), Agilent Technologies, Inc. (US), Bio-Rad Laboratories, Inc. (US), Takara Bio Inc. (Japan), GenScript (US), and Eurofins Scientific (Luxembourg). These companies have adopted various strategies such as the development of advanced products, partnerships, contracts, expansions, and acquisitions to strengthen their position in the protein expression market. The organic and inorganic strategies have helped the market players expand globally by providing advanced authentication and brand protection solutions. However, the high market consolidation acts as a barrier for new entrants in the market. Thermo Fisher Scientific Inc. (US) is the largest player in the protein expression market offering a wide range of protein expression products and services, including expression systems and kits, expression vectors, competent cells, and instruments such as electroporators and MS systems. The company has a significant global footprint due to its robust sales and distribution network. Additionally, multiple production sites at various geographic locations give the company an edge over other players in the protein expression market. With the reduced demand for COVID-19 products, the company has shifted its focus toward strengthening its core business. The company acquired PPD in 2021 to enhance its clinical research capabilities, allowing it to maintain its leadership in vaccine and therapy development supporting its leadership in the protein expression market. Moreover, in June 2021, Thermo partnered with Advanced Electrophoresis Solutions Ltd. (AES) (Canada) to enhance therapeutic protein development by utilizing protein separation techniques. The company aims to expand its market presence by investing in R&D, which enhances its expertise in protein expression solutions and services, allowing it to offer innovative products and services to the market. Merck KGaA (Germany) is a key player in the protein expression market. The company offers a wide range of protein expression solutions and services, such as assays, reagents, devices, software, protein sample preparation services, and detection & quantification kits, through its science & lab solutions subsegment under its life science business unit. With a strong geographic presence in over 120 countries, Merck KGaA focuses on expanding its customer base, particularly in the fast-growing Asia Pacific region, where it established life science centers in China, India, South Korea, and Singapore from 2021 to 2023. To maintain its market leadership, the company has made significant investments in research and development. For instance, in 2023, the company allocated USD 2.6 billion toward R&D to enhance its product offerings. Additionally, between 2022 and 2024, it expanded its manufacturing and research facilities in Germany, China, France, and Ireland. By prioritizing digitalization, automation, and process improvements, along with these strategic investments, the company seeks to further strengthen its global market presence and ensure sustainable growth. Danaher Corporation (US) is a key player in the protein expression market owing to its strong product portfolio including reagents, kits, and instruments used throughout the protein expression process. The company leverages its strong geographic presence and advanced technological capabilities to maintain its position in the protein expression market. The company focuses on acquisitions, collaborations, and expansions, such as the 2022 acquisition of CEVEC Pharmaceuticals to support and improve its protein expression portfolio. In the same year, Danaher's subsidiary, Cytiva, collaborated with Nucleus Biologics to improve custom cell media development for cell and gene therapies. Moreover, in 2022, the company established its chromatography resins manufacturing facility in the US, supporting protein purification and analysis. In 2023, the company's Life Sciences segment saw a 1.5% sales increase, driven by a 4.0% price rise, higher core sales in life science research, and contributions from acquisitions. These strategic moves have helped Danaher become a dominant player in the protein expression market. Agilent Technologies, Inc. (US) is a life science company offering various instruments, software, services, and consumables to support laboratory operations. Their extensive portfolio includes protein expression products such as competent cells, expression vectors, protein purification kits, and transfection tools. Agilent Technologies, Inc. has its primary R&D and manufacturing sites in the US, Australia, China, Denmark, Germany, India, Italy, Malaysia, Poland, Singapore, and the UK. The company utilizes direct sales channels as well as distributors, resellers, and electronic commerce to distribute its offerings. The company increased its R&D investments in the Life Sciences and Applied Markets segment by 1% from the previous year (2022), totalling USD 297 million in 2023. This funding helps develop new and innovative products and solutions to meet the changing needs of clients. For more information, Inquire Now!
Bloomberg
06-05-2025
- Business
- Bloomberg
Well-Timed Bearish Drug ETF Bet Pays Off on Vaccine Chief News
An unusually large bearish bet on a drug ETF gained almost $800,000 as drug stocks reeled following the appointment of Vinay Prasad as director of the Food and Drug Administration's Center for Biologics and Research.
Bloomberg
06-05-2025
- Health
- Bloomberg
FDA Names Vinay Prasad as New Head of Vaccines, Biologics
FDA Commissioner Marty Makary named Vinay Prasad, a hematologist oncologist and critic of the Covid-19 vaccine for children, as the next director of the Center for Biologics and Research. Prasad joins the Food and Drug Administration from the University of California at San Francisco, where he served since 2020 as an epidemiology professor. Prasad previously worked at the National Cancer Institute, where he completed a fellowship in cancer prevention and was a fellow in hematology and oncology at the National Institutes of Health.
