Reference Standards for Monoclonal Antibodies: Key Challenges Addressed
|
|
- Randolf Hines
- 6 years ago
- Views:
Transcription
1 CASSS WCBP 2012: 16th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products January 23-25, 2012 Reference Standards for Monoclonal Antibodies: Key Challenges Addressed Matthew Borer, Ph.D. Advisor Analytical Sciences Research and Development Eli Lilly and Company
2 The Role of Reference Standards: Pharmaceutical Analysis Reference Standards are developed as part of the analytical control strategy for each drug product Each reference standard has a control strategy of its own Reference Standards play a central role in assuring the quality of medicines for patients during cgmp testing and release activities 2012 Eli Lilly and Company 2
3 Typical RS Packaging Options Bulk containers dispense upon customer order Prepackaged powder Screw-cap bottle Flame-sealed ampoule Content-per-vial Lyophilized Stable compounds No handling issues Less expensive materials Infrequent use Efficient dispensing (resources & materials) Convenient for lab (end-use dating) Protection from oxygen and moisture Shipping limited quantity exception Difficult to weigh Hygroscopic, flocculent Expensive or limited supply Toxic 2012 Eli Lilly and Company 3
4 Key Challenge: Packaging Solution o presentation typically y mandatory Poly-cryovials Re-closable ampoules No special filling equipment Compatibility testing CO 2 ingress adsorption extractables Cryo-compatible glass ampoules Hermetic seal Inert atmosphere Fewer issues with adsorption/extractables Less expensive Single use Special filling equipment 2012 Eli Lilly and Company 4
5 Key Challenge: Sterility Is Sterility Required? The reference standard d is used in cell-based assays where contaminant t organisms can proliferate Contaminant organisms can grow and degrade peptides on storage Or Not? Reference materials are not drug products, so patient safety is not impacted Aseptic manufacturing is difficult and facilities might not accept some source materials An Answer: Sterile filter the bulk reference material source solution Prepare the reference materials in a clean environment Store reference materials frozen Include a broad-spectrum antibiotic in the cell culture medium 2012 Eli Lilly and Company 5
6 Key Challenge: Source Material Selection Development batch or batch used in toxicological testing. May be sourced dfrom mixed pool of clones. Recommended to replace the initial batch with one derived from the FHD batch, or a batch that is representative. Replace batch only when projected to stock-out or in the event of a significant ifi process change. First Laboratory RS New Batch New Batch Commercial Development First Human Dose (FHD) First Efficacy Dose (FED) 2012 Eli Lilly and Company 6
7 Source Material: Commercialization Derived from, or representative of, a batch used in pivotal clinical studies. Represents the final optimized commercial process. Compendial RS Primary RS New Batch (unlikely event) Secondary RS New Batch New Batch Formal Stability Global Registration Prefer to source from same packaging run as the first Primary RS. Subsequent Secondary RS sourced from a representative batch Eli Lilly and Company 7
8 Key Challenge: Characterization Reference standard characterization must be customized to support its specific intended use ICH Q3a, IV Reference standards d used in the analytical l procedures for control of impurities iti should be evaluated and characterized according to their intended uses. WHO, Annex 3, Technical Report Number 885,3 It is necessary to consider all data obtained from testing the material by a wide variety of analytical methods. When taken as a whole, this will ensure that the substance is suitable for its intended use. The extent of the analyses required depends on the purpose(s) for which the chemical reference substance is to be employed, and may involve a number of independent laboratories. ISO 34, It should be recognized that a reference material needs to be characterized mainly to the level of accuracy required for its intended purpose 2012 Eli Lilly and Company 8
9 Typical mab Characterization Tests Appearance Identity Light and Heavy Chain MS Protein Quantity UV Charge Heterogeneity Ion-exchange chromatography Purity Size-exclusion HPLC Reduced SDS-PAGE (or CE- SDS) Oligosaccharide Profile Capillary Electrophoresis-LIF Potency Bioassay ph 2012 Eli Lilly and Company 9
10 The Characterization Challenge No way to fully define the Potency of a mab using physiochemical testing, so the Primary RS defines biological activity but The Primary RS has no basis for comparison, so monitoring for change in Potency is hampered and Bioassay methods are typically highly variable, making it difficult to measure small changes 2012 Eli Lilly and Company 10
11 Potency Assignment Strategy: Initial Batch First Laboratory RS is assigned a value of 100% RS Relative Potency (RP) Laboratory Subsequent Laboratory RS batches are assigned relative to the previous Laboratory RS Primary RS Secondary RS The Primary RS is assigned a value of 100% RP Confirmation of a dose response relationship For-information-only Bioassay comparison to Laboratory RS more extensive for IgG1 mabs due to greater potential for potency change Extensive physicochemical comparability testing to Laboratory RS The initial Secondary RS is based on the same characterization tests as the Primary RS (same source material) A subsequent Secondary RS is assigned a value of 100% RP if the bioassay versus the Primary RS is within a pre-defined window 2012 Eli Lilly and Company 11
12 Potency Assignment Strategy: Replacement Batch Laboratory RS Analyzed by the biological assay using 5 independent measurements relative to the previous RS If the average relative potency is within % RP, the new reference standard will be assigned a value of 100% RP If the average potency falls outside of the interval, an investigation is conducted. Question the suitability of the material Consider a larger number of replicate measurements in order to assign the RP directly to the previous standard 2012 Eli Lilly and Company 12
13 Potency Assignment Strategy: Replacement Batch Secondary RS Analyzed by the biological assay using 10 independent measurements relative to the Primary RS If the average relative potency is within % RP, the new reference standard will be assigned a value of 100% RP If the average potency falls outside of the interval, an investigation is conducted Question the suitability of the material Consider a larger number of replicate measurements in order to assign the RP directly to the previous standard 2012 Eli Lilly and Company 13
14 Independent Measurement Defined Independent Measurement - In General An average reported result based on a replication strategy that encompasses appropriate variance components associated with the measurement Independent Measurement for Bioassay Three plates Three replicates at each dose level for each: Sample Standard Control sample 2012 Eli Lilly and Company 14
15 Key Challenge: Ongoing Suitability for Use (a.k.a. a stability) Comprehensive physicochemical testing Monitoring bioassay curve parameters over time Overprotective packaging and storage temperature Assess representative stability (e.g., from the commercial process) Stress stability Promote the implementation of higher order standard (e.g., WHO International Standard) Careful control of bioassay Use of an independent control material Control over key reagents Consistent technique and comprehensive analyst training Control over instrumentation 2012 Eli Lilly and Company 15
16 Future Challenges The difficulties associated with characterization of biomolecule reference standards make harmonization of multiple compendial reference standards a challenge Global manufacturers must meet regional standards Different doses of the same drug in different regions does not make sense for patients Differences in compendial RS assignments can happen Variability in measurements Differences in the characterization approach This will be a particular challenge for monoclonal antibodies 2012 Eli Lilly and Company 16
17 Co-Authors Kimberley B. Dancheck Kristi L. Griffiths Bryan J. Harmon Jerry J. Lewis Jerry Zhirui Lian Bhavin S. Parekh 2012 Eli Lilly and Company 17
Pharmaceutical Reference Standards: Overview and Role in Global Harmonization
Matthew Borer, Ph.D., Advisor Pharmaceutical Reference Standards: Overview and Role in Global Harmonization 3rd DIA China Annual Meeting Beijing, China, 16-18 May, 2011 What is a Pharmaceutical Reference
More informationMinimization of Bioassay Test Result Shift When Implementing New Reference Standard Batches
CASSS 16 17 April 2018 Minimization of Bioassay Test Result Shift When Implementing New Reference Standard Batches Dr. Matthew Borer*, Kim Dancheck, Dr. Paul Faya, Dr. Kristi Griffiths, David Lytle, Dr.
More informationPHARMACEUTICAL REFERENCE STANDARDS
PHARMACEUTICAL REFERENCE STANDARDS 11 th International Symposium organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe 3-4 September 2012, Strasbourg,
More information11 th INTERNATIONAL SYMPOSIUM ON PHARMACEUTICAL REFERENCE STANDARDS. Siriphorn Laomanacharoen 21 December 2012
11 th INTERNATIONAL SYMPOSIUM ON PHARMACEUTICAL REFERENCE STANDARDS Siriphorn Laomanacharoen 21 December 2012 11 th INTERNATIONAL SYMPOSIUM ON PHARMACEUTICAL REFERENCE STANDARDS Organised by European Directorate
More informationThe United States Pharmacopeia Strategy on Biotherapeutic Products Standards. Jaap Venema, Ph.D. Chief Science Officer & Chair, Council of Experts
The United States Pharmacopeia Strategy on Biotherapeutic Products Standards Jaap Venema, Ph.D. Chief Science Officer & Chair, Council of Experts U.S. Pharmacopeia Who We Are Scientific, independent, volunteer-driven,
More informationANTIBODY DRUG CONJUGATES AND BISPECIFIC ANTIBODIES: SCIENTIFIC & REGULATORY CHALLENGES AND OPPORTUNITIES
ANTIBODY DRUG CONJUGATES AND BISPECIFIC ANTIBODIES: SCIENTIFIC & REGULATORY CHALLENGES AND OPPORTUNITIES Brian DiPaolo 08 June 2017 CASSS Midwest Discussion Group Agenda Introduction Antibody Drug Conjugates
More informationValidation of Analytical Methods used for the Characterization, Physicochemical and Functional Analysis and of Biopharmaceuticals.
Validation of Analytical Methods used for the Characterization, Physicochemical and Functional Analysis and of Biopharmaceuticals. 1 Analytical Method Validation: 1..1 Philosophy: Method validation is
More informationStability of Biological Products
Stability of Biological Products Dr Jurgen Lindner Principal, BioPharma Consulting & Executive Secretary, APIMAA Biological Products Functional Proteins or Polypeptides (mab s, enzymes & inhibitors, growth
More informationBiotechpharma company profile. Romanas Ramanauskas Business development manager
Biotechpharma company profile Romanas Ramanauskas Business manager October, 2012 1 Contents History Company overview Services and capabilities Expression system and process Technology scale-up and GMP
More informationRegulatory Considerations on. Office of Biotechnology Products
Regulatory Considerations on Multiproduct t Facilities for Biotechnology Products Jun Park, Ph.D. Division of Monoclonal Antibodies Office of Biotechnology Products OPS/CDER/FDA 2011 CASSS CMC Strategy
More informationUSP Chapter 823 USP 32 (old) vs. USP 35 (new)
USP Chapter 823 USP 32 (old) vs. USP 35 (new) Sally W. Schwarz, MS, BCNP Research Associate Professor of Radiology Washington University School of Medicine St. Louis, MO Why USP Chapter ? FDA has
More informationAntibody-Drug Conjugate Characterization and Quality Assurance
Antibody-Drug Conjugate Characterization and Quality Assurance Sarah Kennett Division of Monoclonal Antibodies Office of Biotechnology Products OPS/CDER/FDA October 12, 2011 1 Disclaimer The views and
More informationChanges to a Potency Bioassay for Biotechnology Products: a Regulatory Perspective Kathleen A. Clouse, Ph.D., Director Division of Monoclonal Antibodi
Changes to a Potency Bioassay for Biotechnology Products: a Regulatory Perspective Kathleen A. Clouse, Ph.D., Director Division of Monoclonal Antibodies Office of Biotechnology Products Center for Drug
More informationGuide. recombinant DNA proteins. for the elaboration of monographs on synthetic peptides and. European Pharmacopoeia
Guide for the elaboration of monographs on synthetic peptides and recombinant DNA proteins European Pharmacopoeia European Directorate for the Quality of Medicines & HealthCare Edition Council of Europe,
More informationDevelopment. - Be Your Partner-
Development - Be Your Partner- 1 Product development and management 2 Product development and management A good product development is based on a strong product management. Mycenax sproject management
More informationCMC Strategy Forum Japan November Piyanan Boonprasirt Bureau of Drug Control Thailand Food and Drug Administration
CMC Strategy Forum Japan 2015 9-10 November 2015 Piyanan Boonprasirt Bureau of Drug Control Thailand Food and Drug Administration 1 1. Background 2. Organization Chart 3. Biological Products 4. Regulation
More informationCASE STUDY: THE USE OF PRIOR KNOWLEDGE IN ESTABLISHMENT OF AN INTEGRATED CONTROL STRATEGY AND CLINICALLY RELEVANT SPECIFICATIONS
CASE STUDY: THE USE OF PRIOR KNOWLEDGE IN ESTABLISHMENT OF AN INTEGRATED CONTROL STRATEGY AND CLINICALLY RELEVANT SPECIFICATIONS BARBARA RELLAHAN MS, PHD DIRECTOR, PRODUCT QUALITY PRESENTATION OUTLINE
More informationDeveloping the Control Strategy for Enhanced Testing and Continuous Monitoring
Developing the Strategy for Enhanced Testing and Continuous Monitoring i Graham Tulloch, PhD Research Advisor BioProcess Research and Development Outline Introduction Regulatory environment strategy t
More informationAntibody-Drug Conjugates The Road to the Current State. Nila Das, Ph.D. American Drug Delivery & Formulation Summit San Diego, CA June 13, 2016
Antibody-Drug Conjugates The Road to the Current State Nila Das, Ph.D. American Drug Delivery & Formulation Summit San Diego, CA June 13, 2016 1 Current Status of ADCs C&E News. 2014, 92(3): 13-21 2 Current
More informationADVANCES IN PHARMACEUTICAL INDUSTRY FOR WELLNESS AND SUSTAINABLE HEALTH
ADVANCES IN PHARMACEUTICAL INDUSTRY FOR WELLNESS AND SUSTAINABLE HEALTH Faculty of Pharmaceutical Sciences Chulalongkorn University Industrial pharmacy is a discipline which includes manufacturing, development,
More informationExtractables and leachables: An Introduction
Extractables and leachables: An Introduction Tim Hulme Smithers Rapra THulme@smithers.com 44(0)1939 252 418 1 Extractables and leachables: An Introduction Tim Hulme Smithers Rapra thulme@smithers.com 2
More informationRegulatory Challenges for the Licensure of Future Vaccines
Regulatory Challenges for the Licensure of Future Vaccines Tong Wu, Ph.D. Bacterial & Combination Vaccine Division, BGTD, Health Canada June 26-29, 2018, Seoul, Korea, the Global Bio Conference 1 Disclaimer
More informationPHARMACEUTICAL REFERENCE STANDARDS
PHARMACEUTICAL REFERENCE STANDARDS 11 th International Symposium organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe 3-4 September 2012, Strasbourg,
More informationCASSS CMC Strategy Forum Barcelona, Spain. EBE Satellite Session Comparability Concept Paper 21 st March 2011
CASSS CMC Strategy Forum Barcelona, Spain EBE Satellite Session Comparability Concept Paper 21 st March 2011 Aim of concept paper Points to consider in planning and undertaking of comparability exercise
More informationFDA recommendations for comparability studies to support manufacturing changes. Joslyn Brunelle, PhD Office of Biotechnology Products OPQ/CDER/FDA
FDA recommendations for comparability studies to support manufacturing changes Joslyn Brunelle, PhD Office of Biotechnology Products OPQ/CDER/FDA The views and opinions expressed here should not be used
More informationDevelop A Highly Similar" Biosimilar Compound: Lessons Learnt
Develop A Highly Similar" Biosimilar Compound: Lessons Learnt Hui-Chun Li, Ph.D. Sr. Manager of Process Science 2015 Feb 05 3rd Biologics World Taiwan 2015 SPIN OFF ACQUISITION Development Center for Biotechnology
More informationAncillary Materials for Cell & Tissue Therapies Definitions, US Regulatory Approach, and USP s Risk-Tiered Approach
USP/ISCT Workshop 2012 Seattle, WA, USA Ancillary Materials for Cell & Tissue Therapies Definitions, US Regulatory Approach, and USP s Risk-Tiered Approach Elizabeth Read, MD Head of Product Development
More informationRegulatory Perspective on Analytical Method Validation During Product Development
Regulatory Perspective on Analytical Method Validation During Product Development CASSS CMC Strategy Forum 2018 Jacek Cieslak CDER/OPQ/OBP FDA Disclaimer This presentation reflects the views of the author
More informationRegulatory Issues and Drug Product Approval for Biopharmaceuticals
Regulatory Issues and Drug Product Approval for Biopharmaceuticals Vinod P. Shah, Ph. D. FIP Scientific Secretary Biotech 2007 Southern African Regional and International Regulatory Biotechnology Workshop
More informationExpert Consensus on Quality Control and Preclinical Evaluation of Antibody-Drug Conjugates
Expert Consensus on Quality Control and Preclinical Evaluation of Antibody-Drug Conjugates National Institutes for Food and Drug Control July 20 th, 2018 Contents 1. Overview... 3 2. Manufacturing... 4
More informationTechnical Challenges in the Development of Biosimilars. E. Morrey Atkinson, PhD Interphex May 1, 2012
Technical Challenges in the Development of Biosimilars E. Morrey Atkinson, PhD Interphex May 1, 2012 FDA Guidance on Biosimilarity Guidance for Industry: Scientific Consideration in Demonstrating Biosimilarity
More informationQuality Issues for Clinical Trial Materials: The Chemistry, Manufacturing and Controls (CMC) Review
Quality Issues for Clinical Trial Materials: The Chemistry, Manufacturing and Controls (CMC) Review Presented by Erika E. Englund, Ph.D. Slides courtesy of Dorota Matecka, Ph.D. Office of Pharmaceutical
More information2-2 Sterile Product Assessment. Satish Mallya Ph.D Training Workshop CPH, May 2015
2-2 Sterile Product Assessment Satish Mallya Ph.D Training Workshop CPH, May 2015 Focus Overview of Regulatory Requirements Tips for Critical Thinking Issues and Solutions Regulatory Requirements - Overview
More informationThe Role of Mass Spectrometry for Developing Biotherapeutics: Regulatory Perspectives
The Role of Mass Spectrometry for Developing Biotherapeutics: Regulatory Perspectives Jun Park, Ph.D. Division of Monoclonal Antibodies Office of Biotechnology Products CDER/FDA CASSS, Applications of
More informationLAB EXPERTS AT YOUR SIDE Over twenty years of experience
LAB EXPERTS AT YOUR SIDE Over twenty years of experience About us SYNLAB Pharma offers a broad range of laboratory services to the biotechnology, pharmaceutical and cosmetic industries as well as to manufacturers
More informationPROCESS VALIDATION ROCHAPON WACHAROTAYANKUN, PH.D.
Basic GMP Requirement PROCESS VALIDATION ROCHAPON WACHAROTAYANKUN, PH.D. Topic Process validation What and Why? Principle of process validation Manufacturing process validation Aseptic process validation
More informationProcess Performance Monitoring & needed engagement tools
Process Performance Monitoring & needed engagement tools September 17, 2014 Barbara Allen, Ph.D. Global Quality Systems Eli Lilly and Company Core Objective Safely & reliably manufacture quality medicines
More informationTable 37: Design of Stability Studies for Biotechnology Product Development and Lifecycle Management A New USP Chapter
Table 37: Design of Stability Studies for Biotechnology Product Development and Lifecycle Management A New USP Chapter FACILITATOR: Bharat Dixit, Finch Therapeutics SCRIBE: Mimi Roy, BioMarin Pharmaceutical,
More informationOn the Q&A to the Guideline for Common Technical Documents
To: Public Health Bureau Prefectural Government Letter from PFSB/ELD 22 nd October 2001 From: Evaluation & Licensing Division, Pharmaceutical & Food Safety Bureau, The Ministry of Health, Labour and Welfare
More informationPMDA Perspective on Specifications for Biotechnological Products
WCBP 2016, January 26 28, 2016, The Mayflower Hotel, Washington, DC, USA PMDA Perspective on Specifications for Biotechnological Products Yasuhiro Kishioka, Ph.D. Principal Reviewer Office of Cellular
More informationPHARMACEUTICAL TESTING
WHITEHOUSE, NJ PHARMACEUTICAL TESTING Pharmaceutical Expertise for GMP & CMC Testing Our Pharmaceutical Expertise With more than 20 years of experience in a variety of industries, our Whitehouse, New Jersey
More informationCharacterization of Biotechnology Products: A Regulatory Perspective
Characterization of Biotechnology Products: A Regulatory Perspective Laurie Graham Acting Team Leader FDA/CDER/OPS/OBP Division of Monoclonal Antibodies WCBP 2013 1 Disclaimer The views and opinions expressed
More informationGuideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE- GENERAL Health systems and products Medicinal products quality, safety and efficacy 18 February 2010 EMA/CHMP/BWP/534898/2008 Committee for Medicinal
More informationReplacing Analytical Methods for Release and Stability Testing CBER Perspective
Replacing Analytical Methods for Release and Stability Testing CBER Perspective Presentation at the CMC Strategy Forum January 27, 2014 Lokesh Bhattacharyya Chief, Lab of Analytical Chemistry and Blood
More informationPRAXIS. A publication by Bioengineering AG
PRAXIS A publication by Bioengineering AG Portrait of Rentschler Biotechnologie GmbH, a globally active service company that supports its clients in the development, production, and registration of biopharmaceuticals.
More informationRegulatory Review Considerations of Drug-Linker Quality in ADCs
Regulatory Review Considerations of Drug-Linker Quality in ADCs Xiao Hong Chen, Ph.D. Acting Quality Assessment Lead Division of New Drug Products I, Branch II ONDP/OPQ/CDER/FDA Outlines ADC IND submissions
More informationBiosimilars Scientific Challenges and Implications
Biosimilars Scientific Challenges and Implications Professor Paul Declerck Laboratory for Therapeutic and Diagnostic Antibodies paul.declerck@pharm.kuleuven.be Biological medicinal product A well-defined
More informationQuality of raw materials and manufacturing of advanced therapies. Fouad Atouf, Ph.D. Head, Global Biologics July 12, 2018
Quality of raw materials and manufacturing of advanced therapies Fouad Atouf, Ph.D. Head, Global Biologics July 12, 2018 Evolution of the compendia 1820: a single recipe book 2018: Procedures and acceptance
More informationCapillary Electrophoresis Compendial Applications
Capillary Electrophoresis Compendial Applications Anita Szajek, Ph.D. Principal Scientific Liaison, Biologics & Biotechnology 14 th Symposium on the Practical Applications for the Analysis of Proteins,
More informationSTANDARD OPERATING PROCEDURES. Handling and working with Analytical Standards
Page: 1 of 6 1.Purpose The purpose of this Standard Operating Procedure is to establish a standardized procedure of using United States Pharmacopoeia (USP) standards, detailing the procedure of qualification,
More informationASMF/DMF Quality Assessment Report (QAR) IGDRP Quality Working Group
ASMF/DMF Quality Assessment Report (QAR) IGDRP Quality Working Group Version Description of Change Author Effective Date v 1.0 Original publication ASMF/DMF WG May 26, 2015 v 1.1 Watermark added ASMF/DMF
More informationGuideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials
1 2 3 18 February 2010 EMA/CHMP/BWP/534898/2008 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 7 Guideline on the Requirements for Quality Documentation Concerning Biological Investigational
More informationThank You to United States Pharmacopeia for Their Sponsorship and Assistance
Use of Measurement Uncertainty in Testing a Drug Substance M.L. Jane Weitzel Quality Analysis Consultants mljweitzel@msn.com Eurachem/CITAC Workshop June 2011 Thank You to United States Pharmacopeia for
More informationPh. Eur. monographs and biosimilars
Ph. Eur. monographs and biosimilars Emmanuelle Charton, Ph. D. European Pharmacopoeia Department European Directorate for the Quality of Medicines & HealthCare 1 Place of the Ph. Eur. within the EU regulatory
More informationTable 12: Design of Stability Studies for Biotechnology Product Development and Lifecycle Management A New USP Chapter
Table 12: Design of Stability Studies for Biotechnology Product Development and Lifecycle Management A New USP Chapter FACILITATOR: Joseph Kutza, A member of the AstraZeneca Group SCRIBE: Camilla Santos,
More informationValidation Needs for Sterilization by Aseptic Filtration
Validation Needs for Sterilization by Aseptic Filtration DCVMN Workshop, Hyderabad, 4-8 April 2016 Ramesh Raju Associate Director - Provantage Validation Services Overview Key Regulatory and Industry guidelines
More informationAnalytical Tools for Higher Order Structure Assessment in Comparability and Biosimilarity
Analytical Tools for Higher Order Structure Assessment in Comparability and Biosimilarity Brad Jordan, PhD Director, Global Regulatory and R&D Policy Amgen Inc. CASSS HOS 2018 Providence, RI How good are
More informationGuideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
1 2 3 23 June 2016 EMA/CHMP/BWP/534898/2008 rev. 1 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 7 Guideline on the requirements for quality documentation concerning biological investigational
More informationfact sheet 3 Introduction to Biosimilars & Regulatory Requirements
3 fact sheet 3 Introduction to Biosimilars & Regulatory Requirements International Alliance of Patients Organizations CAN Mezzanine 49-51 East Road London N1 6AH United Kingdom International Federation
More informationLaboratory Services Alcami s comprehensive development and testing services are well established and ready to assist your pharmaceutical product
Laboratory Services Alcami s comprehensive development and testing services are well established and ready to assist your pharmaceutical product needs. The Alcami Advantage Alcami specializes in all phases
More informationProposed Revision of USP General Chapter Radiopharmaceuticals for Positron Emission Tomography Compounding <823>
Proposed Revision of USP General Chapter Radiopharmaceuticals for Positron Emission Tomography Compounding Ravi Ravichandran, Ph.D. Steve Zigler, Ph.D. February 21, 2011 Agenda Rationale for the
More informationReference Standards for Bioassays
Reference Standards for Bioassays C Jane Robinson Principal Scientist Biotherapeutics National Institute for Biological Standards & Control, Health Protection Agency, UK Jane.Robinson@nibsc.hpa.org.uk
More informationReference Standards: Overview and Strategy for Development to Commercialization
Reference Standards: Overview and Strategy for Development to Commercialization John Ruesch Analytical Research and Development CASSS / WCBP CMC Strategy Forum: Reference Standards For Therapeutic Proteins
More informationEuropean Medicines Agency Evaluation of Medicines for Human Use
European Medicines Agency Evaluation of Medicines for Human Use London, 22 February 2006 EMEA/CHMP/BWP/49348/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL
More informationOctober 10, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852
October 10, 2017 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA 2017 D 2802: Chemistry, Manufacturing, and Controls
More informationCritical Quality Attributes for Biotechnology Products: A Regulatory Perspective
Critical Quality Attributes for Biotechnology Products: A Regulatory Perspective Patrick G. Swann, Ph.D. Deputy Director Division of Monoclonal Antibodies Office of Biotechnology Products Office of Pharmaceutical
More informationInspection Trends. American Society for Quality Richmond, VA Section March 8, 2016
Inspection Trends American Society for Quality Richmond, VA Section March 8, 2016 Brooke K. Higgins, Senior Policy Advisor CDER / Office of Compliance Office of Manufacturing Quality Division of Drug Quality
More informationGuideline for the Quality, Safety, and Efficacy Assurance of Follow-on Biologics
Provisional Translation (as of April 19, 2013) PFSB/ELD Notification No. 0304007 March 4, 2009 To: Prefectural Health Department (Bureau) From: Evaluation and Licensing Division, Pharmaceutical and Food
More informationA FDA Product Reviewer s Perspective on Building A Quality Dossier
A FDA Product Reviewer s Perspective on Building A Quality Dossier CASSS Mid-West Discussion Group October 29, 2015 University Center of Lake County, Grayslake, IL Howard Anderson, PhD Team Lead Product
More informationJapanese Pharmacopoeia s Challenge to the Globalization
Japanese Pharmacopoeia s Challenge to the Globalization Naoyuki Yabana, Ph.D. Division of Pharmacopoeia and Standards for Drugs, Office of Standards and Guidelines Development, Pharmaceuticals and Agency
More informationThe Complete Solution: Althea s Simplified ADC Supply Chain
The Complete Solution: Althea s Simplified ADC Supply Chain You have the power to make a difference. To make new therapeutics that improve quality of life and inspire a healthier world. To do this, you
More informationControl Strategy. Implementation of ICH Q8, Q9, Q10
Implementation of ICH Q8, Q9, Q10 Control Strategy International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Introduction Structure of this session
More informationPrioritizing and Managing Key CMC Elements
Prioritizing and Managing Key CMC Elements Using 21 st Century Principles during Early Development Laurie Graham Product Quality/CMC Reviewer FDA/CDER/OPS/OBP Division of Monoclonal Antibodies 1 Disclaimer
More informationReplacing Analytical Methods for Release and Stability Testing A Regulatory Perspective
Replacing Analytical Methods for Release and Stability Testing A Regulatory Perspective Presentation at The IVT s 12 th Annual Analytical Procedure and Method Validation Conference Dec 12, 2016 Lokesh
More informationBioConvergence Technical Paper
BioConvergence Technical Paper # 2012001 Application of Thermal Analysis in Lyophilization Development and Optimization Kara Strass* and Kelly L. Zaleski, Ph.D.* *BioConvergence LLC, 4320 West Zenith Drive,
More informationNotice Our file number:
June 15, 2015 Notice Our file number: 15-107053-353 Adoption of ICH 1 Guidance: Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process Health Canada
More informationICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management
1 2 3 14 December 2017 EMA/CHMP/ICH/804273/2017 Committee for Medicinal Products for Human Use 4 5 6 7 ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle
More informationHow do you know the drug you are using is safe and effective?
The Chemistry, Manufacturing, and Controls (CMC) Technical Section: The Big Picture of a Long-term Commitment AAVPT Workshop February 28, 2011 James K. Nitao, Ph.D. Biotherapeutics Team Division of Manufacturing
More informationBiological Reference Preparations
Biological Reference Preparations What are biological reference preparations? Biological medicines are complex and usually require biological assays. Biological assays employ either living animals, tissues,
More informationGuideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
14 September 2017 EMA/CHMP/BWP/534898/2008 rev. 1 Committee for Medicinal Products for Human Use (CHMP) Guideline on the requirements for quality documentation concerning biological investigational medicinal
More informationRecent experience in scientific advice and marketing authorisations
Recent experience in scientific advice and marketing authorisations Presented by Brigitte Brake on 16 April 2015 BfArM & BWP, Germany An agency of the European Union Introduction Short introduction to
More informationPhase Appropriate GMPs for IMPs. Presented by: Karen S. Ginsbury For: IFF, October 31, Nov 02, 2017
Phase Appropriate GMPs for IMPs Presented by: Karen S. Ginsbury For: IFF, October 31, Nov 02, 2017 1 Lets start with References https://mhrainspectorate.blog.gov.uk/2016/0 5/20/manufacture-of-investigationalmedicinal-products-frequently-askedquestions/
More information9/2/2014. USP Monograph Modernization. Todays topics. USP basic. Todays topics. - USP basic. - USP publications. - USP monograph modernization
USP Monograph Modernization Procedure Review and Development Donald Min 2 USP basic Since USP's founding in 1820, our operations have grown exponentially: from 11 volunteers collaborating from their respective
More informationValidation/Verification of Test Methods An FDA Perspective. Laure H. Kairawicz, Ph.D. Senior Scientist Expert Witness
Validation/Verification of Test Methods An FDA Perspective Laure H. Kairawicz, Ph.D. Senior Scientist Expert Witness FD & C Act Overview Definition of drugs What cgmps are Finished Pharmaceuticals cgmp
More informationBeing Clinically Relevant While Setting Specifications
Being Clinically Relevant While Setting Specifications CASSS Midwest Forum Hyatt Regency St. Louis, MO March 15, 2018 Aparna Deora, Ph.D. Biotherapeutics Pharmaceutical Sciences Analytical Research & Development
More informationRegulatory Expectations for Method Transfers: Health Canada's Perspective CMC Strategy Forum Methods on the move January 23, 2017
Regulatory Expectations for Method Transfers: Health Canada's Perspective CMC Strategy Forum Methods on the move January 23, 2017 Hugo Hamel, Senior Biologist/Evaluator, BGTD Overview of the Post-NOC Changes
More informationRegulatory expectations on impurities in drug substances - Pavia, October 2, Luisa Torchio Euticals SpA
Regulatory expectations on impurities in drug substances - Pavia, October 2, 2015 Luisa Torchio Euticals SpA An Impurity is defined as any substance or element present in a drug substance (DS) that is
More informationBIOPHARMACEUTICAL PROCESS EVALUATED FOR VIRAL CLEARANCE
The purpose of Viral Clearance evaluation is to assess the capability of a manufacturing production process to inactivate and/or remove potential viral contaminants. Experience and knowledge in selecting
More informationMicrobiology Testing: USP requirements for Sterile and Nonsterile Preparations Webinar Q&A
USP Antimicrobial Effectiveness Testing Microbiology Testing: Webinar Q&A 1. If a base ingredient is designed for the purpose of compounding a specific type of preparation does this forgo the necessity
More informationOverview Rentschler Biotechnologie
Overview Rentschler Biotechnologie AusBiotech, Adelaide, 18.10.2011 Klaus B. Schoepe, PhD, SVP Client Relations - 1 - Our Mission As an independent leading, internationally operating service company, we
More informationCURRENT CHALLENGES IN GLOBAL REGULATORY COMPLIANCE QUALITY OF PHARMACEUTICAL INGREDIENTS PHARMACOPOEIAL HARMONISATION PROCESS
CURRENT CHALLENGES IN GLOBAL REGULATORY COMPLIANCE QUALITY OF PHARMACEUTICAL INGREDIENTS PHARMACOPOEIAL HARMONISATION PROCESS Dr. Vinay G Nayak President, Technical Operations Alembic Pharmaceuticals Limited
More informationICH Q11 Development & manufacture of drug substances
ICH Q11 Development & manufacture of drug substances Keith McDonald Group Manager Medicines & Healthcare products Regulatory Agency (UK) 2011 ICH International Conference on Harmonisation of Technical
More informationCleaning and Cleaning Validation of API Plant and Equipment
Regulatory Basis: FDA Quality Systems Regulations Reference: FDA CFR - Code of Federal Regulations Title 21 1 Purpose The purpose of this guideline is: To define the requirements for cleaning plant and
More informationExamples of regulatory expectations for analytical characterization and testing
Examples of regulatory expectations for analytical characterization and testing AT Europe 2016, 18 March 2016 Vicki Venizelos Quality RA B.V. Leiden, the Netherlands Overview What are the regulatory expectations?
More informationLeachable and Extractable Testing
Leachable and Extractable Testing A Primer on Regulations and Methods As presented to By: Anthony Grilli, MS General Manager SGS LSS NJ Laboratory 973 244 2435 Anthony.Grilli@SGS.com Summary Why perform
More informationA GUIDE TO BIOMANUFACTURING AT GENZYME
M A K I N G P R O T E I N T H E R A P I E S A GUIDE TO BIOMANUFACTURING AT GENZYME Genzyme strives to make a life-changing difference for patients with serious diseases by discovering, developing, and
More informationVICH Topic GL40. at Step 7 GUIDELINE ON TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW BIOTECHNOLOGICAL/BIOLOGICAL VETERINARY MEDICINAL PRODUCTS
European Medicines Agency Veterinary Medicines and Inspections London, 15 November 2005 Doc. Ref. EMEA/CVMP/VICH/811/04- corrigendum 1 VICH Topic GL40 at Step 7 GUIDELINE ON TEST PROCEDURES AND ACCEPTANCE
More informationReflection Paper. The Role of Product-specific Monographs for Biotherapeutic Products in Pharmacopoeias
Reflection Paper 3 October 2014 The Role of Product-specific Monographs for Biotherapeutic Products in Pharmacopoeias This reflection paper describes a scientific and regulatory rationale for a new format
More information