ADCs: Requirements in terms of GMP and occupational safety

Dr. Richard Denk one of our valuable speakers.

Richard Denk is Head of Sales Containment at SKAN AG, which is based in Allschwil, Switzerland. In 2008 he established the panel of containment experts within ISPE Germany/Austria/Switzerland (DACH), which published the Containment Manual in November 2015. He is also an author for Maas & Peither GMP Publishing on the topics of containment and hygienic design, as well as one of the authors of the ISPE Oral Solid Dosage Baseline Guide. He has been focusing on the manufacture of highly active / highly hazardous substances for almost 20 years now, and also developed the Containment Pyramid for use in this area

He kindly sent us an article named ADCs: Requirements in terms of GMP and occupational safety, which he wrote in collaboration with Dr. Flueckiger from Roche.

Antibody-drug conjugates (ADCs) are a new generation of highly active pharmaceutical products used, among other things, in the targeted treatment of cancer. For health and safety reasons, most of these ADCs require containment down to the double or triple-di- git ng/m3 range.

Manufacturing ADCs is a new challenge, particularly in aseptic production. Isolators have been used successfully in this area for many years now. They are, however, also called upon to provide active personal protection. A contradiction in terms? At first glance, yes. While the aseptic process must be operated in positive pressure in accordance with Good Manufacturing Practice (GMP) requirements, personal protection isolators are typically operated in negative pressure in order to prevent the hazardous substance from escaping. Special seals on the isolator, innovative filter technology and a well-conceived pressure- cascade concept with active mouse holes make it possible to protect both product and personnel.”

Authors also states that ADCs are a new generation of highly active and hence extremely challenging substances in the pharmaceutical industry that call for state-of-the-art containment for their manufacture.

While the quantities manufactured in the initial phase of development are low, there is a significant risk of coming into contact with the product if suitable protective measures are not taken. Isolator technologies are suitable for handling ADCs safely, but require innovative solutions and safety precautions.

Take a look at the insights of this research and download full article here.

This year Dr. Richard Denk will be speaking on HPAPIs Summit about Containment Requirements for HPAPI with an OEL in small Ng/m3 range for OSD or BioTech Products like ADCs. Everyone will have opportunity to ask Dr. Richard and other speakers personally about business insides and future opportunities.

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