Dr Rainer Gnibl
GMP Inspector
Referent:innen
Georg Göstl
Takeda Manufacturing Austria
Dr Kerstin Brack
Charles River Laboratories Germany
Zielsetzung
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
Hintergrund
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.
Zielgruppe
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.
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.
Programm
Gesamtes Programm als PDF herunterladen
ECA/BioPhorum - Introduction and Organisational of the Joint Conference
Raw Material Management with United States Pharmacopeial Standards for Cell Therapy
Dr Minkyung Kim, APAC
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
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
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)
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
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.
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
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
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
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
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
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
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
Alexander Bartes, Roche
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