The training will deal with the legal, policy, economic, social and ethical issues arising from the application of biotechnology techniques and the use of their methods and products in various sectors, such as medical, agricultural, etc. In an international and comparative perspective, after introducing to the fundamentals of biology, genetics, intellectual property and patent law, different regulatory systems for research and development using controversial biotechnology techniques, including human genetic modification and cloning, GMOs, CRISPR, etc., will be analyzed.

Mammalian cell culture plays a crucial role in the production of biopharmaceuticals, including monoclonal antibodies, recombinant proteins, and cell and gene therapies.Through a combination of theoretical learning and practical application, participants will gain the knowledge and skills necessary to optimize productivity, efficiency, and product quality in mammalian cell culture processes.

The new ICH guidelines Q14 and Q2(R2) give a new new on analytical life cycle management and analytical method validation. With the introduction of the Analytical Target Profile (ATP), the requirements for method validation and method transfer have changed. The new validation guideline ICH Q2(R2) is now additionally oriented towards new methods such as spectroscopy, bioassays and coupled techniques.

This CMC Masterclass offers an immersive exploration into the critical aspects of Chemistry, Manufacturing, and Controls (CMC) for biopharmaceuticals. This comprehensive program covers the full spectrum of biologics; from monoclonal antibodies to advanced therapies like nucleic acids and viral vectors as well as cell therapies.

For most frequent diseases such as hypertension or dyslipidemia good treatment exists already. Occasionally, new treatments emerge for old or new frequent challenges, such as vaccines against COVID-19 or drugs against obesity. To stay competitive, in 2023 the EU anounced a fundamental revision of its pharmaceutical legislation, including the duration of marketing exclusivity, unmet medical needs, incentives, clinical trials for rare/orphan & pediatric diseases, and cell & gene therapies.

Technology transfer is a critical process in biopharmaceutical manufacturing, facilitating the transfer of processes, technologies, and knowledge between development and manufacturing sites. Through a combination of theoretical learning and practical application, participants will emerge equipped with the knowledge and skills to excel in technology transfer projects and drive innovation in biopharmaceutical manufacturing.

The manufacturing of Antibody-Drug Conjugates (ADCs) is intrinsically complex and a strong chemistry, manufacturing and control (CMC) strategy is vital due to the complex nature of these therapeutics and history of failures at both early and late stages. This training encompasses a comprehensive understanding of the primary technical and regulatory (FDA and EMA) challenges