CMC Academy Afternoon

During the COVID19 crisis and in the winter of 2022/23, the industrial drug supply was discussed in detail in public. In addition to the actual efficacy and therapy concepts, the production and quality of the products are also at stake. Supply bottlenecks, impurities, storage temperature, etc. dominated the public debate for quite some time.

The material, chemical-pharmaceutical basis of active ingredients and excipients is central to this, and is referred to here in simplified terms as Chemistry, Manufacturing & Controls (CMC).

The production of many new active ingredients is now based on biotechnology. This requires special knowledge and procedures. Kaiserslautern University of Applied Sciences at the Pirmasens site has already been dedicated to this special academic training since 2012 and 2017, respectively, with the Applied Pharmacy and Industrial Pharmacy degree programs.

At the workshop, possible needs on the part of industry - keyword shortage of skilled workers - will be discussed, but also the improvement of academic biotech CMC training. And it is about new impulses and thought-provoking impulses for the associated teaching and research tasks.

The workshop is aimed primarily at experts and decision-makers from the pharmaceutical industry and the public sector, as well as all those interested in the topic. Participants will not incur any costs.

We kindly ask you to send an informal registration by e-mail to dekanat-alp@hs-kl.de.

Program

13:00 - Welcome address
Greeting by Prof. Dr.-Ing. Hans-Joachim Schmidt (President Kaiserslautern University of Applied Sciences) and others
13:15 - Megatrends in the pharmaceutical industry
Dr. Andreas Brutsche (Vice President Corporate Development, Midas Pharma GmbH)
13:40 - Biotech CMC – The Process is the Product
Can the current mantra of regulatory process focus be dissolved? How and with what biopharmaceuticals are manufactured has important consequences for teaching and applied research.
Prof. Dr. Peter Groß (Pharmaceutical Biotechnology, HSKL)
14:00 - From drug substance to drug product
The best drug substance cannot develop its effect if it does not reach its site of action in the body. This requires complex formulation technologies. The knowledge and skills required for this are taught in the subject of pharmaceutical technology.
Prof. Dr. Stefan Scheler (Pharmaceutical Technology and Biopharmacy, HSKL)
14:20 - Qualified training for employment in the pharmaceutical industry
In addition to scientific fundamentals, employees in the pharmaceutical industry must also have knowledge in regulatory affairs, compliance as well as organization. Building on a scientific degree, competencies and skills are deepened through comprehensive product understanding and knowledge of processes related to the quality of pharmaceuticals.
Prof. Dr. Astrid Schaly (Pharmaceutical Analytics, HSKL)
14:40 - Interchangeability of biosimilars at the pharmacy level
Implementing the interchangeability of biologicals/biosimilars at pharmacy level as a cost containment tool in the regulatory process architecture led to massive criticism. The presentation explains the positions of the individual stakeholders: Physicians, pharmacists and patients, pharmaceutical industry and their associations, as well as EMA and GBA.
Prof. Dr. Niels Eckstein (Reg. Affairs, HSKL)
15:00 - Coffee break and snack
15:30 - Discussion tables
Topic 1: What does a qualified university education in the CMC of biopharmaceuticals need? What are the requirements of academia, industry and authorities? What are the legal hurdles to be overcome? What resources and study models are needed?
Topic 2: What research approaches in the field of CMC of biopharmaceuticals and technological focus in education are needed? Keyword: Industry-oriented teaching and production technology center.
Topic 3: Innovations in regulation: automatic substitution of biosimilars, generics law, reorganization of directives and regulations.
16:30 - Get together
Exhibition of posters, opportunities for exchange on networking projects.
17:30 - End of the event