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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