Biological Raw Materials, Excipients and APis - An ECA, EBE and APIC Joint Conference

20-21 November 2018, Düsseldorf/Neuss, Germany

Course No. 16847

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Speakers

Dr Cornelia Bodinet, Schaper & Brümmer, Germany
Marieke van Dalen, Aspen Oss, The Netherlands
Sergio Fracchia, Novartis, Switzerland
Dr Annick Gervais, UCB, Belgium,
Dr Ralf Klein, ViruSure
Dr Gerd Jilge, Boehringer Ingelheim, Germany
Dr Ingrid Mecklenbräuker, Novartis Pharma Stein, Switzerland
Dr Christoph Mück, Austrian Agency for Health and Food Safety (AGES)
Jennifer Purdie, Eli Lilly, USA
Dr Johannes Reich, MicroCoat Biotechnologie, Germany
Dr Don Singer, United States Pharmacopoeia/ GSK
Christine Weiß, Labor LS, Germany

Objectives

This European Joint Conference is dedicated to quality and regulatory aspects of raw materials used for biological medicinal products. The following topics will be addressed

  • Biological Raw Materials in Pharmacopoeias
  • GMP requirements for raw materials – Guidances
  • The EBE Concept paper on management of raw materials for biologicals
  • Quality Control aspects of Biological Raw Materials
  • Risk management and control of Biological Raw Materials, components and excipients
  • Regulatory aspects, change management and life cycle approach for Biological Raw Materials
In this conference the new EBE Concept paper on management of raw materials for iologicals will be introduced and discussed.

Background

Raw materials (RM) 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.

Target Group

This conference will be of significant value to

  • Laboratory managers
  • Quality control managers
  • Analytical scientists
  • Senior laboratory staff
  • QA Units
  • Qualified Persons (QPs)
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.

Programme

Overview of new materials and excipients – dedicated for material income

  • Overview of new materials and excipients
  • Material income control & product specific or method-related
  • Everything parts with raw material – defined use for manufacturing and quality control
  • Selected methods for raw material release (case study)
Raw and starting materials in the ATMP arena: differences and similarities with biologicals
  • Definition of ATMPs and major differences between ATMPs and Biologicals
  • Starting and raw material: definitions, differences and regulatory landscape
  • Impact of raw and starting materials on ATMP process manufacture and final product quality attributes
  • Example of starting materials and implications in process development, manufacturing and filing
  • Raw materials: differences and similarities between ATMPs and biologicals
  • Human derived materials: a special reagent used in ATMP production
  • Overview
  • Active substance and excipients combinations
  • Stability
  • Regulatory framework
Raw and starting materials in the ATMP arena: differences and similarities with biologicals
Are Pharmacopeial Monograph Criteria Sufficient for Raw Material Specifications?
  • 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
EBE Concept paper on management of raw materials for biologicals
  • Effective management and control of raw materials – minimum requirements from a quality regulatory and business perspective
  • The EBE Concept paper – purpose, structure and content
  • Background information related to raw materials regulatory requirements and industry challenges
  • Key principles to consider in setting up a risk-based RM management approach and control strategy
  • Examples
Quality and regulatory aspects of biological extraction products
  • Quality considerations for biological extraction products (APIs)
  • Naturally sourced products Heparin and hCG
  • Key differences between extracted products and biotech
  • Pros and cons of current (draft) guidance for extracted products
  • Consequences for industry
Importance of a Quality Relationship with a Raw Material Supplier – Industrial Point of View
  • 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
Virus risk minimisation strategies for biopharmaceutical aw materials
  • Basic strategies for understanding and controlling virus risk
  • Historical incidents of contamination in biopharmaceutical products
  • Lessons learned in how best to control the risk
Interactive Discussion:
Organizational cultures and strategies for microbiological control of raw materials

Testing of Raw Materials for Herbal Medicines
  • Requirements for the pharmaceutical quality of herbal medicinal products and raw materials of plant origin
  • Natural microflora of plants and medicinal herbal drugs
  • EP acceptance criteria for the microbiological quality (EP 5.1.8, 5.1.4)
  • Testing procedures (EP 2.6.31)
  • Antimicrobial pre-treatment of herbal raw materials
Detection of pyrogenic contaminations in raw materials
  • Methods for endotoxin and pyrogen detection in raw materials
  • Test interference during raw material testing
  • Low Endotoxin Recovery (LER) and the importance of raw material testing
Testing of Raw Materials - Experiences of a Contract Lab
  • Actual tendencies in testing of raw materials
  • Reasons for suitability and routine testing
  • Water - a special kind of raw material
How to mitigate and control risks related to raw materials, components and excipients – case studies
  • Varying risks to patient safety, depending on their use in the process and the nature of the component
  • Residual concentrations of raw materials in the final drug product - particular concern with respect to patient safety
  • A phase appropriate control strategy - development and update during process development
  • Implementation of risk assessments and subsequent control strategies for residual raw materials for new bioproducts.
Reduced Testing of Raw Materials and Excipients
  • Microbiological Acceptance Criteria
  • Classification
  • Microbiological Characteristics
  • Test Frequency
  • OOE limits
  • Examples

ECA's new Guidance "Analytical Procedure Lifecycle Management"

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This course is part of the GMP Certification Programme "ECA Certified API Production Manager" Learn more

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