PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
News|Articles|November 7, 2019
Rentschler Biopharma to Launch US Center of Excellence
Author(s)Pharmaceutical Technology Editors
The new addition will also launch a single-use bioreactor for the 93,000-ft2 facility.
Advertisement
Rentschler Biopharma, a Germany-based contract development and manufacturing organization (CDMO), announced it is opening a center of excellence in Milford, MA, to expand its US footprint. The new addition will also launch a single-use bioreactor for the 93,000-ft2 facility, according to a Nov. 6, 2019 Rentschler press release.
The new XDR-500 bioreactor is equipped with a working volume of 100–500 L, downstream process capabilities of 2–8 g/L, and is part of the state-of-the-art GMP facility suite concept, according to the release. The system is set to be client-ready in mid-2020.
Additionally, the company is planning on adding a separate building to the site for large-scale and single-use manufacturing, and lab capacity for new modalities.
Dr. Jesús Zurdo, senior vice-president, Innovation and Venture Partnerships at Rentschler, will present the company’s clinical and commercial manufacturing capabilities at BIO-Europe from Nov. 11–13 in Hamburg, Germany.
Source:
Advertisement
Related to this article
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.
AI can turn medical device risk management into a continuous signal.
Sanofi will transfer 20 mature medicines and three manufacturing sites to Cheplapharm for a 26.4% equity stake, closing by Q3 2027.
On PharmTech.com this week, coverage of upcoming events continued, experts continued to discuss the use of AI in pharma, and validation in oral solid dosage product production was emphasized.
Christy Owings, Thermo Fisher, on why early supply chain partnership and site visits prevent costly eCOA and clinical trial delays.
This article explores the historical use of silicone oil in the performance of primary drug product packaging; design of experiment test results for selection of the cleaning agent and CCPs; assessment of visible residue limits and Fourier-transform infrared spectroscopy surface analysis; and setting health-based exposure limits for silicone oil using a non-uniform distribution model, and a previously published permitted daily exposure.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
Driving Quality Culture to Manage Risk: Lessons from an FDA Inspection Response
2
FDA's IND Pilot Puts CMC Review First
3
Mature Medicines Divestment Signals Shift in Manufacturing Strategy
4
Successful Internal Audit Planning and Execution
5