Dr. Markus Fido

How to build knowledge about raw materials?
Dr Markus Fido, VelaLabs, Austria

  • Overview Raw Materials and Excipients
  • Test Methods and Analysis
  • Importance for Development and Manufacturing


Dr Christoph Mück

Special materials in special products – biological excipients/raw materials in biopharmaceuticals
Dr Christoph Mück, AGES, Austria

  • Overview
  • Active substance and excipients combinations
  • Stability
  • Regulatory framework


Sergio Fracchia

Raw and starting materials in the ATMP arena: differences and similarities with biologicals
Sergio Fracchia, Novartis, Switzerland

  • 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


Dr Don Singer

Are Pharmacopeial Monograph Criteria Sufficient for Raw Material Specifications?
Dr Don Singer, USP, USA

  • 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


Dr Annick Gervais

EBE Concept paper on management of raw materials for biologicals
Dr Annick Gervais, UCB, Belgium

  • 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


Marieke van Dalen

Quality and regulatory aspects of biological extraction products
Marieke van Dalen, Aspen Oss, The Netherlands

  • 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


Dr Don Singer

Importance of a Quality Relationship with a Raw Material Supplier – Industrial Point of View
Dr Don Singer, USP, USA

  • 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


Ralf Klein

Virus risk minimisation strategies for biopharmaceutical products
Ralf Klein, Virusure, Austria

  • Basic strategies for understanding and controlling virus risk
  • Historical incidents of contamination in biopharmaceutical products
  • Lessons learned in how best to control the risk


Dr Cornelia Bodinet

Testing of Raw Materials for Herbal Medicines
Dr Cornelia Bodinet, Schaper & Brümmer, Germany

  • 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


Dr Johannes Reich

Detection of pyrogenic contaminations in raw materials
Dr Johannes Reich, MicroCoat Biotechnology, Germany

  • Methods for endotoxin and pyrogen detection in raw materials
  • Test-interference during raw material testing
  • How Endotoxin Recovery (LER)  and the importance of raw material testing


Christina Weiß

Testing of Raw Materials - Experiences of a Contract Lab
Christina Weiß, Labor LS, Germany

  • Actual tendencies in testing of raw materials
  • Reasons for suitability and routine testing
  • Water - a special kind of raw material


Jennifer Purdie

How to mitigate and control risks related to raw materials, components and excipients – case studies
Jennifer Purdie, Eli Lilly, USA

  • 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.


Dr Don Singer

Interactive Discussion: Organizational cultures and strategies for microbiological control of raw materials
Dr Don Singer, USP, USA


Dr Ingrid Mecklenbräuker

Reduced Testing of Raw Materials and Excipients
Dr Ingrid Mecklenbräuker, Novartis, Switzerland

  • Microbiological Acceptance Criteria
  • Classification
  • Microbiological Characteristics
  • Test Frequency
  • OOE limits
  • Examples


Dr GerdcJilge ECA’s new Guidance “Analytical Procedure Lifecycle Management”
Dr Gerd Jilge, Boehringer Ingelheim, Germany