Raw Materials, Excipients and APIs Used for Biological Medicinal Products Jointly organised by ECA Academy, BioPhorum, and APIC

Raw Materials, Excipients and APIs Used for Biological Medicinal Products

Neuss, Germany

Seminar Nr. 20316

 

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Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Janmeet Anant, EMD Milipore
Dr Andy Bailey, ViruSure
Dr Annika Böhm, MicroCoat Biotechnologie
Amandine Calvet, Boehringer Ingelheim
Marieke van Dalen, Aspen Oss B.V.
Dr Markus Fido, MFi Bio-Consulting
Dr Jörg Hoernschemeyer, F. Hoffmann-La Roche
Benjamin Jequier, Takeda
Sidonie Karlsson, Amniotics
David Keen, Ecolab
Solène Le Maux, EDQM
Dr Ingrid Mecklenbräuker, Novartis Pharma Stein
Dr Radha Tirumalai, Consultant, formerly USP
Christine Weiß, Labor LS

Zielsetzung

This European Joint Conference is dedicated to quality and regulatory aspects of raw materials, excipients and APIs used for biological medicinal products. The following topics will be addressed
  • Biological raw materials in Pharmacopoeias
  • GMP requirements for raw materials – Guidances
  • Supplier relationships and qualification
  • Quality control aspects of biological raw materials
  • Risk management and control of biological raw materials, components and excipients
  • Raw Materials for ATMPs

Hintergrund

Raw materials (RM) and other products used in the manufacture of biological medicinal products need to be well understood with respect to their role in the manufacturing process. In particular in a GMP-regulated environment these raw materials, components as well as excipients require a thorough control regarding consistent quality. Therefore, all critical quality attributes should be known and appropriate risk mitigation and control strategies should be established. As there are currently no written industry guidelines available dedicated to a risk-based biological raw materials management approach the European Pharmaceutical Enterprises, EBE, has developed a concept paper entitled “Management and Control of Raw Materials Used in the Manufacture of Biological Medicinal Products“ in which the principles of such a risk-based approach is outlined.

Zielgruppe

This conference will be of significant value to
  • Laboratory Managers
  • Quality control Managers
  • Analytical scientists
  • Senior laboratory staff
  • QA Units
  • Qualified Persons (QPs)
  • R&D
from biopharmaceutical companies, ATMP developers and manufacturers as well as vaccine Producers.

This conference also addresses employees of contract labs being involved in development of methods, control testing and Quality Assurance as well as staff from regulatory affairs departments.

Presentations / Certificate / Hygiene Measures

The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.

On site, we will implement the necessary and required hygiene measures in close co-operation with the hotel. If infection rates and/or travel restrictions generally do not permit an on-site event, will be postponed or offered live online. In this case, you will be informed in due time.

Programm

BioPhorum Raw Materials Strategic Framework
Benjamin Jequier, Takeda
  • Background and importance of branch solutions
  • Standard definitions, a common understanding of raw material requirements and the importance of regulatory, quality and supply chain linkages
Are Pharmacopeial Monograph Criteria Sufficient for Raw Material Specifications?
Dr Radha Tirumalai, Merck, formerly USP
  • Microbiological criteria for many raw materials are not globally harmonized
  • Scientists use pharmacopeial criteria as a rule or they customize criteria. There are risks and benefits to using pharmacopoeial criteria for specifications
  • A practical and appropriate approach to raw material microbiological specifications will be discussed
Industry Proposal for Second Sourcing of Critical Materials
Isabelle Lequeux, BioPhorum
  • Importance of second sourcing
  • The Use of QbD and ICH Q12 tools and principles to enable second sourcing
Qualification of Direct Materials – Process of Initial and Ongoing Qualification of Suppliers. A Case Study 
Dr Joerg Hoernschmeyer, F. Hoffmann-La Roche
  • Qualification process of direct material suppliers
  • Regulatory prerequisites and requirements
  • Initial and ongoing qualification of direct materials for use in pharmaceutical preparations
  • Risk evaluation and management process of materials and suppliers
Importance of a Quality Relationship with a Raw Material Supplier – Industrial Point of View
David Keen, Ecolab
  • Robust medicinal products for patients depend on a robust supply chain
  • Microbiological quality of raw materials require control for assurance in the supply chain
  • Different origins of raw materials lead to different risk management approaches
  • Suppliers must have control to ensure quality and safety attributes are met
  • Alignment of supplier-customer expectations leads the way to quality
Quality and Regulatory Aspects of Biological Extraction Products
Marieke van Dalen, Aspen Oss
  • Quality considerations for biological extraction products (APIs)
  • Naturally sourced products Heparin and hCG
  • Regulatory aspects for biological extraction products
  • Can single guidelines cover both biotech and extraction products?
European Pharmacopoeia Chapter on Raw Materials for ATMPs
Solène Le Maux, EDQM
  • Presentation of texts relevant for raw materials used for biological medicinal products available in the European Pharmacopoeia
  • Focus on the general chapter Raw materials of biological origin for the production of cell-based and gene therapy medicinal products (5.2.12)
  • Update on the activities of the European Pharmacopoeia in this field
Raw Material & Excipients for ATMPs – Analytics & Specifications
Dr Markus Fido, MFi Bio-Consulting
  • Special considerations & new knowledge/requirements
  • Test methods, analytical tools and acceptance criteria
  • Characterization for selected compounds and materials
  • Prerequisites for process development & manufacturing
Personal Experience of Biological Raw Material Sourcing for an Early Stage ATMP and Considerations for Later Clinical Stage Development
Sidonie Karlsson, Amniotics
  • Raw materials of human origin: quality requirements and sourcing
  • Biological raw materials in early clinical phases (and the importance of choosing correctly early during process development)
  • Comparability of biological raw materials and second source suppliers
Approach to Media Fingerprinting Testing of Cell Culture Media
Amandine Calvet, Boehringer Ingelheim
  • Possibilities to achieve a simpler, more accurate ID testing for media
  • Qualifying of across suppliers
Virus Risk Minimisation Strategies for Biopharmaceutical Products
Andy Bailey, ViruSure
  • Basic strategies for understanding and controlling virus Risk
  • Historical incidents of contamination in biopharmaceutical products
  • Lessons learned in how best to control the risk
Endotoxin Testing in Raw Materials with Focus on Lipids
Dr Annika Böhm, MicroCoat Biotechnology
  • Importance of endotoxin testing in raw materials
  • Lipid nanoparticles and interference in Endotoxin Analytics
  • Case Studies
Microbiological Testing of Raw Materials - Experiences of a Contract Lab
Christine Weiß, Labor LS
  • Actual tendencies in testing of raw materials
  • Challenges during testing
  • Case Studies
Risk-Based Microbiological Testing of Active Ingredients and Excipients
Dr Ingid Mecklenbräuker, Novartis
  • Microbiological acceptance criteria
  • Classification
  • Microbiological characteristics
  • Test frequency
  • OOE Limits
  • Examples

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