Manufacturing roundup: Canada to invest $58M+ into 'critical' medicines manufacturing; FDA to accept apps for CMC pilot

23 Mar 2023
endpts.com
Executive ChangeCell Therapy
Canada’s government will invest $58.6 million over five years to support the Canadian Critical Drug initiative and 350 jobs. The initiative plans to boost the R&D and manufacturing sector in the province of Alberta and is spearheaded by the not-for-profit Applied Pharmaceutical Innovation (API), which helps life science companies in the commercialization phase. The funding will help push forward a new 40,000 square foot manufacturing site in Edmonton to produce “critical” medicines, but the specific products were not immediately announced. The facility, once completed, will be able to produce 70 million doses annually. The funds will also go toward upgrading API’s existing R&D facility in Edmonton as well as other R&D programs and clinical trial support. “This project will transform our ability to produce critical medicines through strengthened research and manufacturing systems that will result in economic and health benefits to Canadians while protecting them for years to come,” said the Canadian Minister of innovation, science and industry François-Philippe Champagne, in a release . The FDA will be opening applications on April 1 for its chemistry, manufacturing and controls (CMC) development and readiness pilot program. The program, which was announced last year, will expedite CMC developments under an IND application when necessary. The FDA is applying the program to certain CBER- and CDER-regulated products that have accelerated development timelines. The pilot looks to explore the use of both science and risk-based regulatory approaches. Those that are accepted into the pilot will be able to discuss CMC development strategies and goals with an FDA review staff as well as have other follow-up discussions. Cliningen will be divesting Europe-based contract manufacturer Lamda Laboratories, which will be picked up by the CMDO Adragos Pharma. Lamda will continue to provide services under a pharmaceutical development services agreement. The financial details of the agreement were not disclosed. The divestment also comes after Clinigen had agreed to sell Proleukin (aldesleukin) a treatment for adults with metastatic renal cell carcinoma and metastatic melanoma to Iovance Biotherapeutics. No other details on the deal with Adragos were disclosed. “The agreement to divest Lamda Laboratories is part of a considered review of our strategic direction and represents the next natural step in this journey. We are pleased to have found in Adragos Pharma a trusted partner to build on the success story of Lamda and take it to the next level,” said David Bryant, interim CEO of Clinigen. The cell therapy CDMO Cellipont has netted a debt investment from the healthcare investment company OrbiMed to finance its manufacturing facility in The Woodlands, TX. While the funding was not disclosed, the 76,000-square-foot facility will be able to manufacture CAR-T, IPSC and MSC cell therapies, among others. The project broke ground last November and will be constructed in several phases. Cellipont CEO Deborah Wild said in a release that the facility will open sometime in 2023. “Once completed, Cellipont will be uniquely positioned to offer technically superior, highly-responsive outsourced contract development and GMP manufacturing services to innovative cell therapy companies. OrbiMed understands our vision, has a unique portfolio of life science companies, and was the ideal partner for Cellipont in this journey,” Wild said. The North Carolina-based CDMO Alcami has promoted Ken Morgan to the role of CFO, taking over for Eric Evans, who will be retiring this year after 40 years. Morgan himself has over 25 years of experience in the industry and joined Alcami in 1997 when it was known as AAIPharma and has served in various financial roles within the CDMO.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
-
Drugs
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.