Design and Interpretation of Accelerated Stability Studies of Biologics
|
|
- Sharleen Lyons
- 5 years ago
- Views:
Transcription
1 Design and Interpretation of Accelerated Stability Studies of Biologics Sheila G. Magil, Ph.D. Cambridge Healthtech Institute s Fourth Annual The Bioprocessing Summit 2012 August 20-23, 2012 Boston, MA BioProcess Technology Consultants
2 Outline What is accelerated stability Small molecules vs. biopharmaceuticals Forced Degradation Regulatory Expectations 2 From Clone to Clinic
3 What is Accelerated Stability Stability testing is done to Provide guidance for expiry dating Evaluate how a variety of environmental conditions affect the quality of drug product or drug substance Demonstrate that Drug Product used in a clinical trial maintains suitable quality throughout the trial Accelerated stability studies include Increased temperature studies done during standard stability studies Forced degradation studies done development During analytical method development to identify stability indicating methods 3 From Clone to Clinic
4 Why Perform Accelerated Stability Studies The goals for most Drug Products is no less than 2 years of stability real time stability studies can take at least 2 years Accelerated stability studies can provide useful information on the stability of a drug earlier in development Accelerated stability also provide a way to compare different formulations during development Determine the types of degradation possible 4 From Clone to Clinic
5 Small Molecules vs. Biopharmaceuticals Small molecules degradation generally follows first order kinetics Involves only one kind of molecule Can be fit to a linear or exponential curve It is possible to extrapolate from accelerated temperature degradation to real degradation rate Arrhenius equation ) Biotherapeutics generally do not degrade via first order kinetics Second or higher order kinetics Involve more than a single kind of molecule Biopharmaceuticals are a mixture of multiple forms of the molecule Do not fit linear or exponential curves 5 From Clone to Clinic
6 Kinds of Degradation Seen in Biopharmaceuticals Chemical Degradation Oxidation Deamidation Disulfide bond rearrangement Hydrolysis or internal clipping Physical Degradation Aggregation Adsorption Loss of three dimensional structure 6 From Clone to Clinic
7 Common Conditions Examined in Forced Degradation of Biopharmaceuticals Temperature Higher and lower than proposed storage condition Supporting potential processing conditions ph Extreme ph Based on reasonable ph s to which molecule could be exposed Oxidation May use one or more oxidizing agent Different agents may have different oxidation products Agitation Impact of time Potential impact of shipping Repetitive freezing and thawing Modeling processing conditions Light Inform packaging decisions 7 From Clone to Clinic
8 Example Sample Taken Stress Condition 2H 4H 8H 1D 2D 5D 7D 14D 21D 28D Control 9 8 ph C Temperature 5 C 25 C 40 C Oxidation 10% H 2 O 2 25% H 2 O 2 8 From Clone to Clinic
9 Example continued Sample Taken Stress Condition 2H 4H 8H 1D 2D 5D 7D 14D 21D 28D Control Agitation Freeze/ Thaws Light Exposure 1 week 3 weeks 1 cycle 3 cycles 5 cycles 1.2 M lux-hr artificial daylight 9 From Clone to Clinic
10 Regulatory Guidelines FDA, Health Canada, Therapeutic Goods Administration (Australia) and EMEA have adopted ICH Q5C : Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological products Expiration dating should be based on real time/real temperature data. However it is strongly suggested that studies be conducted on the drug substance and drug product under accelerated and stressed conditions. [Q1A (R2) Stability Testing of New Drug Substances and Products] describes the conditions of the accelerated and stress study, should note that those conditions may not be appropriated for Biotechnological/biological products Conditions should be carefully selected on a case by case basis Q5C also specifies the need to examine the stability of reconstituted lyophilized products as well as drug substances, drug products and intermediates 10 From Clone to Clinic
11 Q1A(R2) Guidance For products stored in refrigerated conditions Real time 5 C ±3 C Accelerated 25 C ± 2 C/60% ±5% RH For products stored at 20 C Real time 20 C ±3 C No accelerated temperature recommended Stability to be examined for drug substances, drug products and intermediates 11 From Clone to Clinic
12 Other Regulatory Guidance WHO Refers to ICH guidances Initiated guidelines for the Eastern Mediterranean Region Accelerated stability tests provide a means of comparing alternative formulations, packaging materials, and/or manufacturing processes in shortterm experiments. As soon as the final formulation and manufacturing process have been established, the manufacturer carries out a series of accelerated stability tests which will enable the stability of the drug product to be predicted and its shelf life and storage conditions determined. Real time studies must be started at the same time for confirmation purposes. Suitable measures should be taken to establish the utilization period for preparations in multidose containers, especially for topical use 12 From Clone to Clinic
13 Summary Accelerated stability is more than examining high temperature conditions during standard stability studies Accelerated stability includes forced degradation studies Forced degradation is used to Identify stability indicating methods Identify degradation pathway Evaluate formulations Evaluate Comparability Accelerated stability supports expiry dating Regulatory guidance for biotechnology products is less prescriptive than for traditional pharmaceuticals 13 From Clone to Clinic
14 Thank You! Sheila G. Magil BioProcess Technology Consultants, Inc. 12 Gill Street, Suite 5450 Woburn, MA 01801
15 Follow us bptcglobal
Stability 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 informationContract Manufacturing of Biosimilars
Contract Manufacturing of Biosimilars Patti Seymour Senior Consultant BioProcess Technology Consultants, Inc. IBC Life Science s Biopharmaceutical Development and Production Huntington Beach, CA February
More informationEffect of Biosimilar Development on Global Manufacturing Capacity
Effect of Biosimilar Development on Global Manufacturing Capacity Patti Seymour Senior Consultant BioProcess Technology Consultants, Inc. IBC Life Science s Biopharmaceutical Development and Production
More informationEssentials in Stability Analysis and Expiry Determination
Published in BioPharma International. Essentials in Stability Analysis and Expiry Determination Thomas A. Little Ph.D. 6/12/2013 President Thomas A. Little Consulting 12401 N Wildflower Lane Highland,
More informationThe GCC Guidelines for Stability Testing of Drug Substances and Pharmaceutical Products EDITION TWO 1428 H 2007 G
The GCC Guidelines for Stability Testing of Drug Substances and Pharmaceutical Products EDITION TWO 1428 H 2007 G (1) INTRODUCTION The following guideline defines the stability data package for a drug
More informationStrategic Outsourcing for Success
Strategic Outsourcing for Success Improving Speed to Clinic using External Sourcing Massachusetts Biotechnology Council Meeting November 16, 2012 Cambridge, MA BioProcess Technology Consultants www.bptc.com
More informationSTABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
More informationBiomanufacturing Capacity for Biosimilars: Is there enough?
Biomanufacturing Capacity for Biosimilars: Is there enough? Cambridge Healthtech Institute s Third Annual BIOAnalytical Summit 2012 Mar 19-22 Baltimore, MD BioProcess Technology Consultants www.bptc.com
More informationNOTICE Our file number:
September 25, 2003 NOTICE Our file number: 03-118437-914 Adoption of ICH 1 Guidance: - This guidance document is a revised version of the ICH Q1A(R) guidance document and defines the stability data package
More informationAPI Stability Protocols and. Chris Byrne Tasmanian Alkaloids
API Stability Protocols and Evaluations Chris Byrne Tasmanian Alkaloids API Stability Overview APIs = 100% pure Limited (if any) degradation No interactions with other agents in drug products Less likelihood
More informationMethod Validation Studies How GLP Interacts With Guidance Documents
Method Validation Studies How GLP Interacts With Guidance Documents Steven S. Kuwahara ROBERT GEORGE YOUNG/GETTY IMAGES GLP Forum addresses topics of interest associated with good laboratory practices.
More informationThe Use of Pharmaceutical Stability Tools in Medical Device Stability Programs
Global SYNTHES Institute of Validation Technology Forum on Stability Programs The Use of Pharmaceutical Stability Tools in Medical Device Stability Programs Laure L. Larkin MSc. CPP. Synthes USA 1 The
More informationGUIDELINE FOR THE STABILITY TESTING
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 GUIDELINE FOR THE STABILITY TESTING OF NON-PRESCRIPTION (OTC)
More informationDraft regional guidelines on stability testing of active substances and pharmaceutical products
Regional Committee for the EM/RC53/12 Eastern Mediterranean August 2006 Fifty-third Session Original: Arabic Agenda item 17 Draft regional guidelines on stability testing of active substances and pharmaceutical
More informationScientific and Regulatory Perspectives on Measuring Protein Aggregation of Biotechnology Products
Scientific and Regulatory Perspectives on Measuring Protein Aggregation of Biotechnology Products Ashutosh Rao, Ph.D. Chief, Laboratory of Applied Biochemistry Division of Biotechnology Review and Research
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 informationWHO GUIDELINE Stability testing of active pharmaceutical ingredients and finished pharmaceutical products
WHO GUIDELINE Stability testing of active pharmaceutical ingredients and finished pharmaceutical products 1. Introduction 1.1 Objectives of these guidelines 1.2 Scope of these guidelines 1.3 General principles
More informationQBD BIOLOGICS: REGULATORY PERSPECTIVE. 8Jun2015 Mark Alasandro
QBD BIOLOGICS: REGULATORY PERSPECTIVE 8Jun2015 Mark Alasandro Acknowledgements Thomas Little Dilip Choudhury Curt Monnig Others Outline Regulatory Perspective Building a QbD based Infrastructure Regulatory
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 informationImpurities from degradation of Drug Substances
Impurities from degradation of Drug Substances REFERENCE 1. ICH - IMPURITIES IN NEW DRUG SUBSTANCES - Q3A(R2) 2. ICH - IMPURITIES IN NEW DRUG PRODUCTS - Q3B(R2) 3. ICH - VALIDATION OF ANALYTICAL PROCEDURES:
More informationStability testing is required for
FOCUS ON... ANALYTICS Outsourcing Stability Testing Discussions with Contract Laboratories by Maribel Rios Stability testing is required for all biopharmaceutical drug products to detect all changes in
More informationRasha Sayed Salama, MD, PhD, UAE
GaBI Scientific Meetings 10 October 2018, Le Meridien Dubai, United Arab Emirates 2nd MENA Stakeholder Meeting on Regulatory Approval, Clinical Settings, Interchangeability and Pharmacovigilance of Biosimilars
More informationFDA S GUIDANCE FOR INDUSTRY ANDAS: STABILITY TESTING OF DRUG SUBSTANCES AND PRODUCTS
FDA S GUIDANCE FOR INDUSTRY ANDAS: STABILITY TESTING OF DRUG SUBSTANCES AND PRODUCTS 02-December-2014 San Diego, CA Kim Huynh-Ba Executive Director PHARMALYTIK Kim.huynhba@pharmalytik.com Overview Stability
More informationBioProcess Technology Consultants, Inc. Helping Clients De-Risk Biopharmaceutical Development Since 1994
, Inc. Helping Clients De-Risk Biopharmaceutical Development Since 1994 Who We Are The biopharmaceutical and biotherapeutic development experts We are a team of results-oriented professionals assisting
More informationVICH Topic GL3. Step 7 (after revision at step 9) GUIDELINE ON STABILITY: STABILITY TESTING OF NEW VETERINARY DRUG SUBSTANCES AND MEDICINAL PRODUCTS
European Medicines Agency Veterinary Medicines and Inspections London, 19 February 2007 Doc. Ref.EMEA/CVMP/VICH/899/99-Rev.1 VICH Topic GL3 Step 7 (after revision at step 9) GUIDELINE ON STABILITY: STABILITY
More informationDrug Product Comparability: Using Process and Product Knowledge for Successful Comparability Exercises
Drug Product Comparability: Using Process and Product Knowledge for Successful Comparability Exercises Jamie Moore Head, Late Stage Pharmaceutical Development CMC Strategy Forum July 18-19, 2016 Many Reasons
More informationBioProcess Technology Group. Helping Clients De-Risk Biopharmaceutical Development Since 1994
Helping Clients De-Risk Biopharmaceutical Development Since 1994 Who We Are The biopharmaceutical and biotherapeutic development experts We are a team of results-oriented professionals assisting clients
More informationEconomic Impact of Single-Use Bioreactors
Economic Impact of Single-Use Bioreactors Rick Stock 2012 BIO International Convention BioProcess Theater Presentation Upstream Processing Boston, MA June 19th, 2012 BioProcess Technology Consultants www.bptc.com
More informationSTABILITY: STABILITY TESTING OF NEW VETERINARY DRUG SUBSTANCES (REVISION)
VICH GL3(R) (QUALITY) January 2007 Revision at Step 9 For Implementation at Step 7 STABILITY: STABILITY TESTING OF NEW VETERINARY DRUG SUBSTANCES (REVISION) Recommended for Adoption at Step 7 of the VICH
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 informationFOOD AND DRUGS AUTHORITY
G H A N A FOOD AND DRUGS AUTHORITY GUIDELINES FOR STABILITY TESTING OF ACTIVE PHARMACEUTICAL INGREDIENTS AND FINISHED PHARMACEUTICAL PRODUCTS Document No: FDA/DRI/DER/GL-STP/2013/07 Date of First Adoption:
More informationCOMMERCIAL PRODUCT STABILITY
COMMERCIAL PRODUCT STABILITY Being Responsible for your Tweener, Senior Citizen and Hospice Stage Products Melissa Lambert Global Head Stability in Quality & Compliance Management, R&D Director Quality
More information1.1. Overview of Drug Stability Studies
1.1. Overview of Drug Stability Studies Everything made by human hands is known to deteriorate and pharmaceutical product is no exception to it. Degradation is a phenomenon where certain measurements of
More informationANNEX V ASEAN GUIDELINES ON STABILITY STUDY AND SHELF-LIFE OF HEALTH SUPPLEMENTS
Association of South East Asian Nations (ASEAN) ANNEX V ASEAN GUIDELINES ON STABILITY STUDY AND SHELF-LIFE OF HEALTH SUPPLEMENTS Disclaimer: This document is provided for information purpose only and subject
More informationPhase Appropriate Method Validation
Phase Appropriate Method Validation Aryo Nikopour Irvine, California January 12, 2017 The Southern California Pharmaceutical Discussion Group (SCPDG) of AAPS OUTLINE What is Validation Guidelines Method
More informationAnnex 10. Stability testing of active pharmaceutical ingredients and finished pharmaceutical products. Introduction and background
Annex 10 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products Introduction and background The guidance on Stability testing of active pharmaceutical ingredients and
More informationFurther Stability Considerations
Further Stability Considerations Radhika Rajagopalan, Ph.D., Team Leader Chemistry Division 2 Office of Generic Drugs, FDA FDA-GPhA Workshop June 4, 2013 1 Agenda Common considerations Q1D Bracketing 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 informationComparability to establish Biosimilarity
Comparability to establish Biosimilarity CMC Strategy Forum Europe 2014, Sorrento, Italy Jan Visser, Head Global Analytical Characterization & Bioanalytics Sandoz Biopharmaceuticals, Hexal AG, Germany
More informationOutline. Opportunities Overview of ASAP Areas of Application ASAP Proposal to Regulators Summary
Outline Opportunities Overview of ASAP Areas of Application ASAP Proposal to Regulators Summary Opportunities n Provide cost benefits and possible alternate methods for demonstrating product stability
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 informationR&D of Biological Products. Rochapon Wacharotayankun, Ph.D., R.Ph.
R&D of Biological Products Rochapon Wacharotayankun, Ph.D., R.Ph. Topic Biological products research and development Process development Product development Novel antigens and Novel excipients Quality
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 informationRoadmap of stability studies for Biosimilarproduct development. Head Biotech Stelis Biopharma
Roadmap of stability studies for Biosimilarproduct development Dr. Rashbehari Tunga Head Biotech Stelis Biopharma 1 Index Introduction Regulatory guideline related to stability Summary of stability requirement
More informationIntroduction regarding aggregate/particle issues in biopharmaceuticals. Yasushi Shikata Eisai Co., Ltd.
Introduction regarding aggregate/particle issues in biopharmaceuticals Yasushi Shikata Eisai Co., Ltd. Activities at biopharmaceutical committee of JPMA Basic question regarding aggregate/particle Pharmaceutical
More informationPerformance by Design: Engineering Functionality into Biopharmaceutical Products
Performance by Design: Engineering Functionality into Biopharmaceutical Products Susan Dana Jones, Ph.D. Cambridge Healthtech Institute Peptalk Overcoming Expression Challenges Session San Diego, CA January
More informationGUIDELINES ON THE STABILITY DATA REQUIRED FOR REGISTRATION OF STOCK REMEDIES IN SOUTH AFRICA
GUIDELINES ON THE STABILITY DATA REQUIRED FOR REGISTRATION OF STOCK REMEDIES IN SOUTH AFRICA Issued by the Registrar: Act No. 36 of 1947, Private Bag X343, Pretoria 0001 Republic of South Africa Tel. (**27
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 informationApplying a Knowledge-Based Approach to Pharmaceutical Supply Chain Temperature Control Management
May 1-3, 2012 Javits Center New York, NY Applying a Knowledge-Based Approach to Pharmaceutical Supply Chain Control Management Arminda O. Montero Program Manager, Distribution QA Global Pharmaceutical
More informationManual 055 Commercial Stability Testing For Formulated Products. This procedure applies to all drug products. The procedure covers:
1 Purpose Manual 055 Commercial Stability Testing For Formulated Products The intent of this procedure is to provide to manufacturing and primary packaging sites the principles of a stability program.
More informationEVALUATION FOR STABILITY DATA
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE EVALUATION FOR STABILITY DATA Q1E Recommended for
More informationRegulatory Consideration for the Characterization of HOS in Biotechnology Products
Regulatory Consideration for the Characterization of HOS in Biotechnology Products Maria Teresa Gutierrez Lugo, Ph.D. OBP/CDER/FDA 5 th International Symposium on Higher Order Structure of Protein Therapeutics
More informationBioProcess. Product Stability Testing. Developing Methods for New Biologics and Emerging Markets. by Maribel Rios. M ay BioProcess International
BioProcess S P E C I A L R E P O R T Product Stability Testing Developing Methods for New Biologics and Emerging Markets by Maribel Rios PHOTO COURTESY OF NOVARTIS AG (WWW.NOVARTIS.COM) M ay 2014 12(5)
More informationStrategies for IND Filing Success: Chemistry, Manufacturing and Controls
Strategies for IND Filing Success: Chemistry, Manufacturing and Controls October 21, 2016 Presented by: Sharon Ayd, Ph.D., MBA Chief Scientific Officer and SVP, Pharmaceuticals document contains proprietary
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP)
The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use London, 17 December 2003 CPMP/QWP/122/02, rev 1 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) GUIDELINE
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 informationReview and highlight existing guidance documents that address pharmaceutical stability and supply chain issues. 3.) Solution
Translating the Requirements of Thermal Cycling / Excursion Guidelines Through the Use of a Comprehensive Risk Management Matrix for Time and Temperature Sensitive Pharmaceutical Products Curtis Strother,
More informationCONSIDERATIONS FOR DEVELOPMENT OF A LYOPHILIZED BIOSIMILAR
CONSIDERATIONS FOR DEVELOPMENT OF A LYOPHILIZED BIOSIMILAR A Case Study The patents for a number of parental biologic formulations are destined to expire in the United States between 2016 and 2027. Some
More informationEarly Development Best Practices for Stability- Regulatory Perspective
Early Development Best Practices for Stability- Regulatory Perspective IQ Workshop, Feb. 4-5, 2014, Washington, D.C. Ramesh Sood, Ph.D. Division Director (Acting) Office of New Drug Quality Assessment
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 informationApplication of ASAP in Early API and Formulation Development
Application of ASAP in Early API and Formulation Development Fenghe Qiu, Ph.D. Boehringer Ingelheim Pharmaceuticals, Inc. Science of Stability, Connecticut, Oct 12-14, 2015 FDA requirement on stability
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 informationStability Testing for Pre-Clinical and Early Phase Clinical Drug Products
Microrite, Inc. brings you this unique learning experience in Stability Testing for Pre-Clinical and Early Phase Clinical Drug Products; Part of Microrite s step-by-step webinar series. Stability Testing
More informationStability Report. Stability profile of. BIWG 98 SE tablets 40 mg SR of 133. This stability report comprises 133 pages.
Stability Report Stability profile of BIWG 98 SE tablets 40 mg Number SR 2001-01-04-01 Date Page 00. 00. 0000 1 of 133 Responsible Company Successful Pharma KG Biberach This stability report comprises
More informationANDAs: Stability Testing of Drug Substances and Products- Industry Perspective
GPhA/FDA FALL TECHNICAL CONFERENCE ANDAs: Stability Testing of Drug Substances and Products- Industry Perspective Nick Cappuccino, Jr., Ph.D., Vice President Scientific Affairs, Dr. Reddy s Laboratories,
More informationTranslational Pharmaceutics : a unique platform to accelerate early oncology development
Translational Pharmaceutics : a unique platform to accelerate early oncology development Lisa Clarke-Lens, Associate Director, Oncology Services Quotient Clinical Clinical Operations in Oncology Trials
More information1225 Eye Street NW, Ste. 400 Washington, DC 20005
1225 Eye Street NW, Ste. 400 Washington, DC 20005 30 June 2005 EMEA Biologics Working Party Secretariat Attention: Linda Olsson European Medicines Agency 7 Westferry Circus Canary Wharf London E14 4HB
More informationIntroduction to CMC Regulatory Affairs
Introduction to CMC Regulatory Affairs Bharathi Mamidipudi Regulatory Affairs Consultant II Syner-G Pharma Consulting, LLC Northeastern University, Boston November 10, 2016 My Background Experience ~4
More informationChapter -1. Importance of Stability Indicating Analytical Methods for Analyzing Organic Impurities in Active Pharmaceutical Ingredients
Chapter -1 Importance of Stability Indicating Analytical Methods for Analyzing Organic Impurities in Active Pharmaceutical Ingredients 1.1 Introduction and importance of stability indicating analytical
More informationPharmacist Rana Musa Al-ali (Malkawi) MSc (Pharmaceutical Quality Assurance) Registration Department/JFDA
Pharmacist Rana Musa Al-ali (Malkawi) MSc (Pharmaceutical Quality Assurance) Registration Department/JFDA 1 2 ND MENA Regulatory Conference On Bioequivalence, Biowaivers, Bioanalysis, Dissolution & Biosimilars
More informationDevelopment of stability indicating studies for pharmaceutical products: an innovative step
Review Article Development of stability indicating studies for pharmaceutical products: an innovative step Gunjan Rao 1, Anju Goyal 2,* Bhopal Nobel s Institute of Pharmaceutical Sciences, Udaipur, Rajasthan
More informationDEPARTMENT OF AGRICULTURE, FORESTRY & FISHERIES STABILITY
DEPARTMENT OF AGRICULTURE, FORESTRY & FISHERIES STABILITY This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Stock Remedies. It represents
More informationThe importance of interchangeability in the procurement of medications: Biosimilar case
The importance of interchangeability in the procurement of medications: Biosimilar case ALIMS Congres, Kragujevac, November 6, 2015 Prof. Borut Štrukelj, PhD Brief CV Current position: professor, Pharmaceutical
More informationCalendar. The Clear Solution to Reach the Global Biopharma Audience. INTERNATIONAL
The Clear Solution to Reach the Global Biopharma Audience yvdavyd/getty Images & blackred/e+/getty Images 2017 EDITOrial Calendar Editorial Coverage Special Themed Issues January Biopharma Outlook for
More informationFormulation Aspects in Biosimilar Development. Kedar S. Gokhale, PhD. Lupin Ltd. (Biotech)
Formulation Aspects in Biosimilar Development Kedar S. Gokhale, PhD. Lupin Ltd. (Biotech) Typical Protein Formulation Components of a protein formulation Active Ingredient Buffer Tonicity modifier Stabilizer
More informationRegulatory perspectives on setting relevant specifications in early development and throughout product life cycle
Regulatory perspectives on setting relevant specifications in early development and throughout product life cycle Ashutosh Rao, R. Ph., Ph.D. Principal Investigator/Product Quality Reviewer Division of
More informationCONSEQUENCES OF SAMPLE AGE ON BIOTHERAPEUTIC HIGHER ORDER STRUCTURE: INSIGHTS FROM NATIVE ION MOBILITY-MASS SPECTROMETRY METHODS
COSEQUECES OF SAMPLE AGE O BIOTHERAPEUTIC HIGHER ORDER STRUCTURE: ISIGHTS FROM ATIVE IO MOBILITY-MASS SPECTROMETRY METHODS Richard Kerr ORISE Post-Doctoral Fellow US FDA, Division of Pharmaceutical Analysis
More informationMAXIMIZING THE VALUE OF CLINICAL TRIALS DATA: A COLLABORATIVE FRAMEWORK FOR DATA STANDARDS GOVERNANCE FROM DATA DEFINITION TO KNOWLEDGE MANAGEMENT
MAXIMIZING THE VALUE OF CLINICAL TRIALS DATA: A COLLABORATIVE FRAMEWORK FOR DATA STANDARDS GOVERNANCE FROM DATA DEFINITION TO KNOWLEDGE MANAGEMENT PharmaSUG Single Day Event Using Standards, Even for Non-Standard
More information参考資料. Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products. Draft
参考資料 1 2 3 4 5 Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products Draft 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 Table of contents 1.
More informationJoint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products
Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products Table of contents 1.Introduction...2 2.Scope...3 3.Discussion...4 3.1. Chemistry, manufacturing, and controls...4
More informationDevelop an Effective Stability Strategy for Product Distribution
Develop an Effective Stability Strategy for Product Distribution Donnie Pulliam, MBA Manager, Global Stability Biogen Research Triangle Park, NC, USA Outline I. Build the Product Distribution Model on
More informationIntelligent Disulfide Bond Analysis
Intelligent Disulfide Bond Analysis Why Study Disulfide Bonds? Save Money by making cell cultures more efficient! Regulations Process Control Higher Quality biotherapeutics Efficacy Protect from Competition
More informationInnovative regulatory thinking to advance pediatric product development:
Innovative regulatory thinking to advance pediatric product development: Prequalification's efforts to address immediate need as guidance to aid long term development progresses Dr. John Gordon WHO Consultant
More informationGuidance for Industry ANDAs: Stability Testing of Drug Substances and Products
Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this
More informationGuidance for Industry
Guidance for Industry Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation
More informationChallenges in the cgmp Manufacturing of hescs: Lessons Learned from Monoclonal Antibodies
Challenges in the cgmp Manufacturing of hescs: Lessons Learned from Monoclonal Antibodies ISCT 2011 Annual Meeting Rotterdam, The Netherlands May 18 21, 2011 BioProcess Technology Consultants www.bptc.com
More informationGuidance for Industry Q3B(R2) Impurities in New Drug Products
Guidance for Industry Q3B(R2) Impurities in New Drug Products U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics
More informationJoint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products
1 2 3 17 January 2013 EMA/CHMP/13099/2013 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 Joint MHLW/EMA reflection paper on the development of block copolymer micelle Agreed by Nanomedicines
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 informationAuthor's personal copy
AAPS PharmSciTech ( # 2015) DOI: 10.1208/s12249-015-0334-9 Meeting Report Strategies of Bringing Drug Product Marketing Applications to Meet Current Regulatory Standards Yan Wu, 1 Anita Freed, 2 David
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 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 informationCorso di Laurea Magistrale in Chimica e Tecnologia Farmaceutiche E25. Fabbricazione Industriale dei Medicinali 4 CFU Prof.
Sezione di Tecnologia e Legislazione Farmaceutiche Maria Edvige Sangalli Corso di Laurea Magistrale in Chimica e Tecnologia Farmaceutiche E25 Fabbricazione Industriale dei Medicinali 4 CFU Prof. Andrea
More informationStability and Characterization of Protein and Peptide Drugs
Stability and Characterization of Protein and Peptide Drugs Case Histories Edited by Y. John Wang Scios Nova, Inc. Mountain View, California and Rodney Pearlman Genentech, Inc. South San Francisco, California
More informationCase Study: A Phase-Driven Approach to the Development and Lifecycle Management of Potency Assays. Spring in New England!!!
Case Study: A Phase-Driven Approach to the Development and Lifecycle Management of Potency Assays CASSS Bioassays 2016: Scientific Approaches & Regulatory Strategies Session Potency Assays: Cell-based
More informationAnalysis of Protein Biopharmaceuticals
Analysis of Protein Biopharmaceuticals Comprehensive cgmp Services at Every Stage of Drug Development Amazing where you can go At Solvias, we work closely with you Solvias provides comprehensive services
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 informationPreclinical Drug Development
Preclinical Drug Development A guidance prepared by From a 2004 NIH Summit Workshop: A major reason for the tremendous cost of drug development is the high rate of drug candidate failure during clinical
More informationStability and Shelf Life of Combination Products. John McMichael FDA/CDRH
Stability and Shelf Life of Combination Products John McMichael FDA/CDRH Combination Products Regulations under 21 CFR 4.4(b) provides that combination product manufacturers may meet the requirements of
More information