With this email we would like to share some of the latest developments in the industry and provide an outlook of some of our key activities. If you would like to receive this update straight to your inbox, please feel free to sign up to our monthly newsletter.
Industry News
An Audit of Pharmaceutical Continuous Manufacturing Regulatory Submissions and Outcomes in the US
In a recent article in the International Journal of Pharmaceutics, June 2022, the authors discuss the regulatory risks that some pharmaceutical companies see with the adoption of continuous manufacturing.
A FDA self-audit of U.S. regulatory submissions, however, found no substantial barriers for continuous manufacturing (CM) applications concerning manufacturing process changes or pre-approval inspections. CM applications experienced faster approval and market entry compared to traditional batch processes, indicating potential benefits in reduced regulatory hurdles and quicker revenue generation.
News at Just - Evotec Biologics
Regulatory Affairs Experts Ensure First-In-Human Success
Discover how the Regulatory Affairs team at
Just – Evotec Biologics collaborates with FIH partners to take their biopharmaceutical candidates into the clinic for the first time.
In this insightful interview, Petra Cavallaro, Head of Regulatory Affairs CMC Biologics, explains how her team ensures successful IND or IMPD applications by overseeing regulatory strategies and compliance for biologics products.
On-demand Webinar
Discover the secrets to exceptional first-in-human project management with Rebecca Hernandez, Global Head of Project Management.
In this insightful webinar Rebecca shares how the Project Management Office (PMO) collaborates closely with clients and internal team members to deliver top-notch project management support for FIH partners.
Winner at the CDMO Leadership Awards 2025
We feel honored to have been selected as a winner in the biologics category of Outsourced Pharma’s CDMO Leadership Awards. Jon Gunther, VP Business Development, took part in the celebration in New York and was thrilled to receive the award. A big thank you to our customers who made this win possible!
Upcoming Conferences
- BioTrinity, London, UK | 1 - 2 April
- Anglo Nordic Life Science Conference XXI, London, UK | 3 April
- Swiss Biotech Day 2025, Basel, Switzerland | 5 - 6 May
- Pharma Manufacturing Conference 2025, Middlesbrough, UK | 7 May
- BIO Korea, Seoul, South Korea, | 7 - 9 May
- Convergence Forum 2025, Chatham, MA | 8 - 9 May
- New Horizons in Biologics & Bioprocessing, Copenhagen, Denmark | 3 June
- BOS Basel 2025, Basel, Switzerland | 11 - 12 June
- BIO International Convention, Boston, MA | 16 - 19 June
We are looking forward to meeting you there!
Reach out to us at info@evotec.com to set up a meeting.
