Raw Materials, Excipients and APIs Used for Biological Medicinal Products
21/22 November 2023, Neuss, Germany
Course No. 21153
Speakers
Dr Rainer Gnibl
GMP Inspector
Georg Göstl
Takeda Manufacturing Austria
Objectives
This European Joint Conference is dedicated to quality and regulatory aspects of raw materials, excipients and APIs used for biological medicinal products. The following topics will be addressed:
Biological Raw Materials in Pharmacopoeias
GMP requirements for raw materials – Guidances
Supplier Relationships and Qualification
Quality Control aspects of Biological Raw Materials
Risk management and control of Biological Raw Materials, components and excipients
Raw Materials for ATMPs
Background
Raw materials (RM), excipients and other products used in the manufacture of biological medicinal products must be well understood in terms of their role in the manufacturing process. Especially in a GMP-regulated environment, these raw materials, components and excipients require thorough control with regard to their consistent quality. Therefore, all critical quality attributes should be known and appropriate risk mitigation and control strategies should be established. Since there is currently less written guidance on risk-based management of biological raw materials, European Pharmaceutical Enterprises, EBE, has prepared a concept paper entitled “Management and Control of Raw Materials Used in the Manufacture of Biological Medicinal Products.” But other approaches can also be helpful - a look at Annex 1 for products that need to be sterile or have a low bioburden claim. Or the QbD approaches for consistent quality of products.
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)
R&D
from biopharmaceutical companies, ATMP developers and manufacturers as well as vaccine producers.
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.
Presentations / Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
ECA/BioPhorum - Introduction and Organisational of the Joint Conference
Raw Material Management with United States Pharmacopeial Standards for Cell Therapy Dr Minkyung Kim, APAC
Regulatory Framework of raw materials and advanced therapies
Risk based qualification programs for raw materials
USP raw material Standards
QbD Approach to Registration of Raw Materials Isabelle Lequeux, BioPhorum
The BioPhorum approach to the registration of raw materials will be presented
The approach is based on Quality by Design principles, and especially a mature approach to define quality for raw materials, including the use of risk assessment
The approach not only allows future flexibility of sourcing of raw materials but also regulatory submissions of higher quality
This presentation is an introduction to the next three BioPhorum presentations.
Protein A Resin Addendum - Direct Application of QbD Approach for Registration of Material Changes to Enable Innovation and Process Efficiency Fabien Rousset, Sartorius
The presentation will summarize the in-depth risk assessment performed by Protein A resin subject matter experts (supplier and end-users in the biomanufacturing industry)
The systematic approach of the risk assessment allows the definition of the critical material attributes of the Protein A resins and of the controls that need to be in place should manufacturers take the opportunity to increase process efficiency by using more performing resins
A proposal is also put forward for regulatory notification of the change, for rapid implementation
Application of QbD Approach to Define Requirements for Changing Sterilization Method for Single-Use Systems from Gamma to X-Ray Dr Samuel Dorey, Sartorius Stedim Biotech
The presentation will summarize the in-depth risk assessment performed by single use system, plastic and radiation experts (suppliers and end-users)
The systematic approach of the risk-assessment allowed for the definition of the critical material attributes of the drug substance holding containers and of the controls that need to be in place for the manufacturers to accept X-ray sterilized containers. The main body of controls will come from the suppliers’ validation and regulatory package and as such the recommendations can also be used by suppliers to ensure adequacy of their assessment of the Change
A proposal is also put forward for global regulatory notification, based on initial feedback from FDA and EMA
Establishing a Unified Approach for Critical Materials in Cell and Gene Therapy Andrew D. Schaefer, Eurofins
The presentation summarizes the in-depth work performed to identify critical quality attributes and proposed standard release testing for recombinant endonuclease and polymer-based transfection reagents
These materials are both used ubiquitously in cell and gene therapy, there is a lack of defined release test criteria throughout the pharmacopeial and regulatory landscape. Without a common test standard there is lack of consistency across suppliers, risk in the supply chain and potential can slow down drug development
This forum of industry professionals set out to propose those release criteria based on the critical material attributes and work carried out using the QbD model.
The team have generated a unified core set of criteria and standard test methods. A common testing standard would have multiple benefits including consistency across suppliers, protection of supplier intellectual property (IP), and facilitation of drug development
Quality and Regulatory Aspects of Biological Extraction Products Dr Edwin Kellenbach, Biochemi Oss B.V.
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
Inspector’s Requirements on Biological (Raw) Materials Dr Rainer Gnibl, GMP/EMA Inspector Government of Upper Bavaria
Focus: ATMPs & biotech products
Requirements on suppliers
Receipt & incoming goods testing
Bank systems
Traceability
Developing a Bio-equivalent Heparin, Decoupled from the Food Chain: Nice to Have or Must Have? Dr Leendert J. van den Bos, Consultant for GlycoTherapeutics BV
Recent progress made in obtaining bioengineered Heparin
Comparing these compounds with the heparins currently on the market.
Could these bioengineered heparins serve as a replacement bio-equivalent to the existing products?
What is the trend with other therapeutics from animal origin?
Quality and Regulatory Aspects of Plasma-Derived Products – A QP’s Perspective Georg Göstl, Takeda
Regulatory Background
Limitations of starting materials
Specific Issues during manufacturing
Certification by the Qualified Person
Potential Issues when using plasma-derived products as excipient
Microbiological Safety - Regulators Aspects and Authority Expectations Jan-Oliver Karo, PEI, German Federal Agency for Vaccines and Biomedicines
Viral Contamination Risk Control Strategies for Biological Raw Materials used in Biomanufacturing Dr Kerstin Brack, Charles River Laboratories
Regulatory aspects in viral safety of biological raw materials used in the manufacturing process of biologics
Viral risk identification and mitigation strategies
Considerations for viral safety of biological raw materials used in ATMP production
Rapid Microbiological Control of Raw Materials with an Automated, Non-destructive Rapid Microbial Detection System Johannes Oberdörfer, RMB
Introduction to the Growth Direct System – hardware and methodology
Raw material and excipient testing – range of application
Case studies and real-world samples – results, evaluations and feasibilities
Endotoxin Detection in Raw Materials Anthea Darius, Microcoat Biotechnology
Testing typical raw materials of drug product formulations
Hot spike and sample hold time experiments
Mitigation of low endotoxin recovery
Mycoplasma Real-Time PCR: Generic Method Validation of T-Cell Culture Alexander Bartes, Roche
This training/webinar cannot be booked. Send us your inquiry by using the following contact form.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
Testimonials
Seminar Programme as PDF