Public-registration training
Quality Management in Manufacturing of Biopharmaceuticals
Three days on manufacturing biopharmaceuticals & quality aspects
Quality Management in Manufacturing of Biopharmaceuticals
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
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
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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.
Previously organized by PAO Farmacie, now by PCS Academy.
Target audience
Professionals in pharmaceutical and biotechnological industries, Professionals in institutions and Contract Research Organisations (CRO’s), Hospital pharmacists and Post-graduate 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 manufacturing 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 and academia will share their wealth of experience and knowledge during the course.The course is 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.
- Understand the up-to-date information on relevant ICH guidelines and have the knowledge where to find EMA and FDA guidance for biopharmaceuticals;
- Apply the knowledge to achieve a compliant QP release of biopharmaceutical products according to the appropriate expectations.
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.
Contents
- 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 (ATMP)
- Biosimilars: a new class of licensed biotech products
- Immunogenicity and formulation of biopharmaceuticals
15 lectures in total. The program is subject to change. The final program will be sent to the participants approximately 1 week before the start of the training. No rights can be derived from this program.
Program - eLearning Component Lecture Sub-lectures Program - Day 1 Lecture Sub-lectures Day Welcome and introduction 1 Introduction to biotechnology: applications and elements of the biotechnological production process; quality and regulatory aspects 1 Upstream process development for biopharmaceutical products 1 Cell line development and cell bank preparation Theory and case study1 Purification survey of unit operations and process integration 1 Program - Day 2 Lecture Sub-lectures Day Design of an industrial process for purification of biologicals 2 Protein analytics of biopharmaceuticals: relevant assays and their principles 2 Development, tech transfer and commercial production of monoclonal antibodies by cell culture – Part 1 2 Development, tech transfer and commercial production of monoclonal antibodies by cell culture – Part 2 2 Program - Day 3 Lecture Sub-lectures Day Pathogen safety 3 Biosimilars: a new class of licensed biotech products 3 Quality challenges for Advanced Therapy Medicinal Products (ATMPs) 3 Critical attributes and comparability studies 3 Immunogenicity and formulation of biopharmaceuticals 3 Evaluation of the course 3 Start date End date Venue Price Status 21-11-2023 23-11-2023 Van der Valk Vianen € 2.590 ex. VAT Open for registration Need training sooner?Click here to get personal training options.
Aad van de Leur
Module Leader, Senior GMP Consultant & Trainer
Aad van de Leur
To start your registration, first select the start date of the training, then fill in the form below.
Register now!
Register for this training by clicking the button.Drag the table left or right to reveal all fields.Learning form: Classroom Times: The course starts at approx. 9:30 am and ends at approx. 5:30 pm Venue(s): Start date Venue Register 21-11-2023
Preparation: Preparation required: Yes Preparation details: Homework Exam: Includes exam: Yes Exam optional: Yes Re-examination possible: No Exam fee in course price: No Examination fee for each exam attempt: 350
€ 2.590 ex. VAT
Training certificate
Lunch buffet
Course dinner
15 Lectures
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