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

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)

• 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

• 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

• 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 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

• 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

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

• 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

• 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

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

• 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.

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