GMP for Biopharmaceuticals - Online Training Recording
Regulatory Requirements and Practical Implementation
Course No. 23034
Speakers
Dr Marcel Günther
Regierungspräsidium Tübingen
Dr Matthias Leitritz
Rentschler Biopharma
Dr Ewoud van Tricht
Kantisto
Stephan Löw
CSL Behring
Friederike Wedelich
Regierungspräsidium Tübingen
Target Group
This course is advisable to people who
are involved in regulatory inspections,
work in quality units at biotech companies,
implement GMP in biotech production,
are responsible for GMP requirements pre-approval phases.
Objectives
This Education Course concentrates on regulatory and practical requirements regarding biopharmaceutical production. From clinical phases to routine manufacturing practical examples and case studies will facilitate the implementation of GMP in your daily business.
The course will treat the topics of routine inspection from regulatory bodies and customers, quality assurance and quality control as well as in laboratory and production.
Speakers from manufacturing, laboratory, consultancy, and authority will show their expectations as well as their experiences in GMP implementation.
Background Good Manufacturing Practice (GMP) is a fundamental regulatory framework designed to ensure that medicinal products are consistently produced and controlled according to quality standards. GMP plays a particularly critical role for biopharmaceuticals - therapeutics derived from living cells or biological processes - given their inherent complexity, variability and sensitivity compared to traditional small-molecule drugs.
Unlike chemically synthesised medicines, biopharmaceuticals such as monoclonal antibodies, recombinant proteins, vaccines and nucleic acid-based therapies are produced using living systems. This introduces unique challenges, including biological variability in raw materials, the susceptibility of production processes to subtle changes, and the risk of contamination by adventitious agents. GMP regulations mitigate these risks by requiring robust systems that safeguard product quality, safety, and efficacy throughout the manufacturing life cycle.
Regulatory authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the International Council for Harmonisation (ICH) have established guidelines that set global expectations. For example, EMA Annex 2 addresses GMP specifically for biologics. Both industry and the authorities must prepare for new and anticipated changes in regulatory guidelines. Compliance with these guidelines is a legal requirement and a means of ensuring patient safety.
Ultimately, GMP in biopharmaceutical manufacturing ensures that complex biological products reach patients with the highest level of assurance regarding their safety, purity, and therapeutic effectiveness. GMP is the backbone of quality systems in the biopharmaceutical industry, balancing regulatory compliance with innovation to support the delivery of life-saving medicines worldwide.
Programme
GMP Guidelines for Biopharmaceuticals – a Brief Summary
Relevant international regulations
European biotech guidance
Recent developments & possible impacts
GMP Requirements Applying to Biotechnological Investigational Medicinal Products (IMPs of Clinical Phases I-III & APIs for use in IMPs)
EU regulations & guidances
Examples of national regulations
State-of-the-art manufacturing for clinical phases
Development of Biopharmaceuticals – GMP, Regulatory Aspects and Inspection & Audit Experiences
EU and US guidances related to clinical trials GMP/CMC incl. Annex 13 update
CDMO considerations on specifications
Inspection and audit experiences “pre-approval”
Development, Qualification and Validation of Process Analytics for Biopharmaceuticals
Analytical Quality by Design (AQbD)
Guidelines ICH Q14, USP <1220>, ICH Q2(R2), USP <1033>
Method development, qualification and Validation
Phase-dependent approach
Link to Critical Quality Attributes (CQAs)
GMP Inspections in Biopharmaceutical Production
Inspections of biopharmaceutical companies
Focus & discussion points during inspections
Clean room classes for biotech facilities
Open vs. closed processing
Single- vs. multi-purpose equipment
Cell banking activities
Inspector’s experience, examples of observations
Process Transfer from Development to Commercial Production from a Quality Perspective
Definition and types of Transfers
Specific quality considerations for transfers
Transition from “development” to “Commercial”
GMP-compliant Process Development and Validation for Biopharmaceuticals
Upstream and Downstream Processing (USP and DSP)
Process validation (Stage 1–3)
Quality by Design (QTPP, CQAs, CPPs, CMAs, design space)
Equipment qualification (URS, DQ, IQ, OQ, PQ)
Process Performance Qualification (PPQ) and Continued Process Verification (CPV)
Surveillance of qualification & validation, calibration and maintenance
Self inspections & auditing
Phase-dependent Strategy and Post-Approval Changes for Biopharmaceutical Development (Phase I–III)
Early versus late phase requirements
Transition towards GMP expectations
Post-approval lifecycle Management
State-of-the-art Biotechnological Manufacture (Bacteria, Yeast, Mammalian Cells) and Cell Banking Activities - Part 1
Reasons for cell banking
Where does GMP start?
Characterisation of cell banks
Storage of cell banks
State-of-the-art Biotechnological Manufacture (Bacteria, Yeast, Mammalian Cells) and Cell Banking Activities - Part 2
Overview of a typical biotech process
Requirements on production areas, raw materials and equipment
Specialities on biotech products
Fill and finish
mRNA Technology – Principles, Manufacturing and Regulatory Perspective
COVID vaccines: Viral and mRNA vaccines
Modular principle of mRNA-based vaccines and mRNA vaccine manufacturing
Regulatory perspective on mRNA products
Application process for updating the MIA
GMP challenges for new biological products
Annex 1 – Impact on the Manufacturing of Biopharmaceuticals
Annex 1: What is the Annex 1 and why has it been revised?
Key principles of the revised Annex 1
Impact on facility, equipment, personal, raw materials, QRM, CCS, …
Case Study: Implementation in the daily business
Further Information
Technical Details To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your Needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
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