Programme

	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
	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
	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
	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
	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
	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
	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
	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
	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
	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
	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
	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.
	Interactive Discussion: Organizational cultures and strategies for microbiological control of raw materials Dr Don Singer, USP, USA
	Reduced Testing of Raw Materials and Excipients Dr Ingrid Mecklenbräuker, Novartis, Switzerland Microbiological Acceptance Criteria Classification Microbiological Characteristics Test Frequency OOE limits Examples
	ECA’s new Guidance “Analytical Procedure Lifecycle Management” Dr Gerd Jilge, Boehringer Ingelheim, Germany