Quality Management in Manufacturing of Biopharmaceuticals

4 rating based on 560 ratings. 560 students

Quality Management in Manufacturing of Biopharmaceuticals

Three days on manufacturing biopharmaceuticals & quality aspects

4 rating based on 560 ratings. 560 students

GMP & GDP training for pharma & biotech

Language(s):

3 days in total

 2.590 ex. VAT

Registration ends in 183 days.

The upcoming start date of this training is guaranteed.

What you'll learn

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

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. 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
Course content

LectureDay
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 study
1
Purification survey of unit operations and process integration

1
LectureDay
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
LectureDay
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

Course dates

Start dateEnd dateVenuePriceStatus
26-11-202428-11-2024Van der Valk Breukelen 2.590 ex. VATRegister

Language

  • Dutch secondary spoken language
    Some lectures/lessons may be in the secondary language. The primary language remains the dominant spoken/written language during the training.
  • English spoken language

General information

Learning form:Classroom
Times:The course starts at approx. 9:30 am and ends at approx. 5:30 pm
Venue(s):
Start dateVenueRegister

26-11-2024

Van der Valk Breukelen

Register

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

Quality Course modules

This module is part of a series called: Quality Management in Pharma and Biotech. This series is designed to give participants an in-depth understanding of the QP’s role and responsibilities. See the other modules in this series below.

4.1 560  2.590 ex. VAT
4.1 455  2.590 ex. VAT
4.3 617  3.225 ex. VAT
3.7 343  2.280 ex. VAT
Quality Management in Manufacturing of Biopharmaceuticals thumbnail
 2.590 ex. VAT

Registration ends in 183 days.

The upcoming start date of this training is guaranteed.

This training includes:

Training certificate

Lunch buffet

Course dinner

15 Lectures

Training 5 people or more?

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