Spotlight on EBE’s Biomanufacturing Working Group

The European Biomanufacturing Enterprises (EBE) continues its spotlight series with a feature on our Biomanufacturing Working Group, which is meeting at the EBE headquarters today.

The objective of the working group is to elevate biotech manufacturing in the technical and quality arena and foster an enabling regulatory environment for the manufacturing of high-quality biological medicines.

One of the great benefits for members is the collaboration and the opportunities to learn from each other. As part of this, members have often hosted meetings at their respective biomanufacturing facilities to share best practices.

The Biomanufacturing Working Group will also play a key role in the upcoming Biological Raw Materials, Excipients and APis Conference, sponsored by EBE, ECA and APIC, which will be held 20-21 November in Dusseldorf. At the conference Dr Annick Gervais of UCB, Belgium will present EBE’s concept paper on management of raw materials for biologicals.

The working group frequently publishes concept papers or position papers that provide practical guidance for manufacturers aiming at an industry-aligned approach, and are used for, e.g. advocacy work with regulatory agencies. The group is about to issue a position paper on a risk-based approach for the identity sampling of biological drug substances.

EBE’s Working Group on Biomanufacturing is one of our five working groups including Advanced Therapies, Innovation and Funding, Biotherapeutics and Personalised Medicine, which offer companies a platform to shape policy and develop and communicate technical positions externally. We’ve already highlighted our Working Group on Personalised Medicines – now stay tuned for our next instalment!

2018-12-13T15:16:30+00:00November 7, 2018|