Q course - Module 4: Quality Management in Manufacturing of Biopharmaceuticals
Starting dates and places
placeVan der Valk Hotel Breukelen 26 Nov 2024 until 28 Nov 2024 |
Description
The training
Biopharmaceuticals are the next generation of medicines. As they originate from live cells, there are several quality concerns and significant technical challenges during development, manufacturing and testing. This module provides participants with a solid understanding of the production of biopharmaceuticals, and critical aspects to understand during development.
Target audience
Professionals in pharmaceutical, biotechnological and medical device industries, Professionals in institutions and Contract Research Organisations (CRO’s), Hospital pharmacists and Postgraduate students.
The course is aimed at (young) professionals in non-clinical and clinical development of new medi…
Frequently asked questions
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The training
Biopharmaceuticals are the next generation of medicines. As they
originate from live cells, there are several quality concerns and
significant technical challenges during development, manufacturing
and testing. This module provides participants with a solid
understanding of the production of biopharmaceuticals, and critical
aspects to understand during development.
Target audience
Professionals in pharmaceutical, biotechnological and medical
device industries, Professionals in institutions and Contract
Research Organisations (CRO’s), Hospital pharmacists and
Postgraduate students.
The course is aimed at (young) professionals in non-clinical and
clinical development of new medicinal products, production,
packaging, Quality Control, Quality Assurance or Regulatory Affairs
who are dealing with complex quality systems. The target audience
needs to gain an in-depth understanding of these systems to improve
quality management in their own organization. The course is an
international training program in English and requires, at minimum,
a Bachelor’s Degree level (HBO level in the Netherlands).
What is it about?
This three-day training provides insight into the development of biopharmaceuticals and how this relates to quality aspects. We will consider the critical steps of developing cell lines, upstream and downstream processes, and commercial production up to protein analysis. Stability, comparability, contamination and immunogenicity will be discussed, as they require special attention compared to API's of non-biological origin.
Course Structure
Expert knowledge and real-life case studies are combined to form
an ideal learning experience. Professionals from industry, academia
and national regulatory authorities will share their wealth of
experience and knowledge during the course.
The course is highly interactive. The program is offered as a
combination of self-study, theory, and practical case studies.
Learning goals
After having followed this course, you will be able to:
- Understand how biopharmaceuticals are produced and what the differences are between small and large (biopharmaceutical) molecules, including the key process units for cell line development, upstream and downstream processing and how they impact product quality.
- Apply critical process parameters (CPP) and critical quality attributes (CQA) for biopharmaceuticals to achieve a robust process.
- Understand how relevant test methods are best applied and what
their limitations are.
Results
After having followed this course, you will have:
- The knowledge to achieve a compliant QP release of biopharmaceutical products according to the appropriate expectations, including awareness of how process changes and small differences may impact quality and safety, including immunogenicity.
- Fundamental tools to achieve a robust manufacturing process and insight into how CPP’s and CQA’s are established using different approaches.
- Up-to-date information on relevant ICH guidelines and knowledge
where to find EMA and FDA guidance for biopharmaceuticals.
Content
- Introduction to biotechnology
- Upstream process development for biopharmaceutical products
- Cell line development and cell bank preparation
- Purification survey of unit operations and process integration
- Design of an industrial process for purification of biologicals
- Development, tech transfer and commercial production of monoclonal antibodies by cell culture
- Pathogen safety
- Protein analytics of biopharmaceuticals
- Critical attributes and comparability studies
- Quality challenges for Advanced Therapy Medicinal Products
- Biosimilars: a new class of licensed biotech products
- Immunogenicity and formulation of biopharmaceuticals
More Information
Go to
https://pcs-nl.com/product/kwaliteitsmanagement-in-farma-en-biotech/?lang=nl
for more information about the modules, the program, trainers,
pricing and registration.
Discount when following all four modules: 20%
Master and PhD students receive a discount of 25%
Prices exclude exam fees
Course leader
Drs. A.C.A.J. (Aad) van de Leur – Byondis
B.V.
Aad van de Leur is working at Byondis BV (formerly Synthon
Biopharmaceuticals BV). In his present function of COO he is
responsible for all Biopharmaceutical operational activities
including process development activities from cell line to Drug
Product development and related analytical development as well as
manufacturing and supply of IMPs with a focus on monoclonal
Antibodies and Antibody Drug Conjugates (ADCs).
Before starting at Byondis, he worked for over 23 years at
different Biotechnology departments at Diosynth and
Organon/Schering-Plough including Cell Culture and Purification
Development, Manufacturing and Project Management.
Do you want to register for this training, this is possible through our website: https://pcs-nl.com/product/quality-management-in-manufacturing-of-biopharmaceuticals-2/. Or send us an email at courses@pcs-nl.com.
PCS - The Practical Compliance Specialists since 1990
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