Small Batches - Live Online Training Special Handling and Production

Small Batches - Live Online Training

Course No 21275

This course is part of the GMP Certification Programme "ECA Certified Biotech Manager". Learn more.

All times mentioned are CET.

Costs

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Eduard Ayuso, Dinamiqs
Dr Constanze Blume, BioNTech
Dr Karin Cooke, Gen-Plus
Dr Markus Dachtler, DiHeSys
Markus Grüll, Autolus
Thorsten Häfner, PSM

Objectives

The training deals with the special features production and quality control of small and very small batches down to batch size 1. The pharmaceutical industry is increasingly faced with the following questions how these products can be economically manufactured and economically. The seminar provides answers to these questions and a precise overview of authorization issues, regulatory environment, manufacturing methods approaches, quality control through to the details from the transition from pre-clinical to commercial stage.

Background

While constant efforts are being made to increase the production of many medicinal products, this is not possible for all of them, as various further developments, such as improved diagnostics or personalized medicine, as well as economic constraints and the diversification of production for different target markets are leading to ever smaller batches down to a batch size of 1 in the case of patient-specific products. Due to developments in recent years and the increasing number of new personalized medicines, the issue of small batches with a worst-case batch size of 1 has become more important. The EDQM, the FDA and other institutions are attempting to create uniform regulations for personalized products with new draft guidelines. However, batch size is rarely considered.

The influence of batch size on the manufacture of a product is immense and affects several areas and should be considered at an early stage. These changes require new concepts in the areas of analysis, filling, production planning and processing and much more.

Target Group

Employees in development, production and quality control of small batches, personalized medicine, specific ATMPs, contract manufacturing and testing.

Technical Requirements

We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Robotic Application in aseptic Contract Filling for Small Batches of ATMPs
Thorsten Häfner
  • Latest system concepts
  • Case Study: Advantages for product and employee protection with a focus on ATMPs
Small Batch Filling - the Path from Phase 1 to commercial Product
Thorsten Häfner
  • Challenges in product developments in clinical trials
  • Case Study: Clinical Phase to commercial filling – Lessons Learned & Best Practices
Personalized Medication – Part 1
Dr Markus Dachtler
  • Digital printing in HealthCare
  • Printing technologies for personalized medication via 2D- and 3D-printing
  • Use of 2D and 3D printers in pharmacies
Personalized Medication – Part 2
Dr Karin Cooke
  • Manufacturing of intermediates for 2D and 3D printing
  • QC in 2D and 3D printing (release, stability and IPC)
  • Case study 1: 2D printed ODF containing Midazolam with personalized dosing
  • Case study 2: 3D printed tablet (polypill)
The Journey of the first UK CAR-T Product from pre-clinical to commercial Stage
Markus Grüll
  • Transition from R&D to GMP
  • Conducting a global ATMP trial during COVID
  • Buildout of own commercial GMP manufacturing site
  • Pathway to Commercialisation under RMAT (FDA), ILAP (UK) and PRIME (EU) programmes
Manufacturing viral Vectors for rare Disorders
Dr Eduard Ayuso
  • How to manage process development with time and budget limitations: a platform Approach
  • Analytical development, qualification of methods and product specifications
  • Small but specialized fill & finish operations
mRNA-based Medicines - Regulatory and CMC Aspects
Dr Constanze Blume
  • Platform approach – how to use for traditional and individualized products
  • BioNTainer – decentralized manufacturing concept for pandemic preparedness and clinical material (Rwanda and Australia)

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