apceth Expands Further its GMP Manufacturing Business
apceth has announced the successful conclusion of a major GMP inspection that reinforces apceth's position as one for the worldwide leading developers and GMP manufacturers of cell and gene therapy products. The GMP inspection was conducted by the Bavarian State Authorities and the Germany regulatory agency Paul-Ehrlich-Institute (PEI).
The subject of the inspection were two innovative medicinal products, which are now included in apceth's GMP manufacturing license according to §13 of the German Medicines Act (AMG).
The first product is Agenmestencel-L, apceth's allogeneic next generation genetically modified mesenchymal stem cells (gmMSCs) for solid cancer. This successful GMP certification of the production process represents a crucial milestone in the development of apceth's allogeneic off-the-shelf product. The second product is a genetically modified ATMP product that apceth is manufacturing at clinical GMP grade for a client.
In addition, two new GMP cleanrooms for aseptic processing were approved and will be used for handling and genetic manipulation of various types of cell and gene therapeutics. The addition further extends the manufacturing capacity of apceth's 600 m2 state-of-the-art GMP facilities.
“This is a very positive development for apceth, one more step in the continuous expansion of our GMP services business and reflects our enduring success in the space. The expansion will ensure that we remain one step ahead of the manufacturing capacity demands of our current and new clients, as well as for our own therapeutic pipeline”, said Ulrike Verzetnitsch, apceth CTO and former Director of Production at Baxter and Takeda. “It is also testament to the expansion of our pipeline of next-generation cell therapies and the efficiency of our non-clinical and pharmaceutical development teams”, she added.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance