Leading the way on innovation and regulation in biomanufacturing

Today the CASSS CMC Strategy Forum Europe 2018 meeting in Noordwijk, the Netherlands, will conclude three days of productive discussions.

European Biopharmaceutical Enterprises (EBE) is delighted to have opened this meeting of biomanufacturing and CMC specialists from around the world with a half day satellite forum.

Biomanufacturing and the specific challenges posed by making biologic and living medicines are a key part of EBE’s work. Our members provide thought leadership, advocacy and guidance on best practices through our reflection, position and concept papers. The current focus of our work includes: the biopharmaceutical industry perspective on the control of visible particles in biotechnology-derived injectable drug products, and the quality aspects of antibody drug conjugates. We are also currently working on combination products containing medicines and devices as well as reflecting on the statistical methodology for the comparative assessment of quality attributes in drug development.

"Great scientific ideas only translate into medicines if you can reliably and repeatedly manufacture them to a specific quality and in the amounts needed to treat patients."

This is where chemistry, manufacturing and controls (CMC)  specialists come in – these are the people who make this whole process possible.

The second part of the forum provided insights regarding the specific challenges of making cutting edge science and patient-specific living medicines, of which CAR-T cells are an example. A complex series of steps, with extra tight controls, ensures that the white blood cells from patients are obtained, the necessary subgroup of white blood cells are isolated and modified to express the antigen receptors needed for the treatment of the patient’s condition, and ensures that ultimately each patient receives his or her own white blood cells in their modified state back.

The overall program of the conference (see here) focused on the following topics:

·     Updates from regulatory authorities around the world;

·     Complexity of combining drugs and devices;

·     Clinical relevance of specifications (for biological medicinal products);

·     Current and future approaches to enhanced development;

·     QbD (Quality by Design) and Design Spaces;

·     Prior knowledge regarding regulatory submissions.

This last topic, in particular, has been a key focus for EBE in 2017, including feedback from the EMA knowledge workshop, allowing for in depth discussions, and providing valuable input into our work.

Such meetings enable open discussions between biomanufacturing experts (including regulators) and are invaluable if we are to find appropriate solutions to making biological medicines of defined quality reliably and in the quantities required by patients.

With this meeting having gone by so fast, I can’t but already be excited for the next one!

For more detail on the work of the EBE working group on biomanufacturing see

Barbara Freischem

Barbara Freischem is Executive Director of the European Biopharmaceutical Enterprises (EBE), since July 2015. EBE...
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