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The new Pharmaceutical Center of Excellence from Nelson Labs offers state-of-the-art chemistry manufacturing and controls (CMC) analytical testing support.
As part of its proposed acquisition, Gilead will add a potential best-in-disease treatment for second-line primary biliary cholangitis (PBC) to its liver portfolio.
The global pharmaceutical suspensions market is set to value $83.8 billion by 2032, due to the systems having key benefits such as supporting patient compliance.
Revisions for two proposed USP chapters recommend changes for rapid tests required for releasing sterile short-life products, as well as for rapid microbiological methods (RMM) for detecting contamination in these products.
Now conditionally approved in Europe for sickle cell disease and transfusion-dependent beta thalassemia, the CRISPR therapy offers eligible patients a functional cure.
The approach applied in the research on bioreactors represents a significant advancement over traditional methods, according to the researchers.
The collaboration between BioNTech SE and Autolus Therapeutics utilises manufacturing and commercial infrastructure, supporting a shared goal of advancing autologous CAR-T programmes towards potential market authorisation.
The drug formulation study offers promise for treating different respiratory tract infections using a single antimicrobial agent, a paper reports.
Phase III trials have found CFTR modulator vanzacaftor/tezacaftor/deutivacaftor (vanza triple) to be non-inferior to TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in improving cystic fibrosis lung function.
Driven by a rise in infectious diseases and advancements in digital technologies, increased demand for rapid microbiology testing is set to accelerate the market’s growth.
Investment in the US manufacturing facility will accelerate AstraZeneca’s ambition to make next-generation cell therapy a reality, the company asserts.
A paper has proposed how advanced manufacturing process technologies such as integrated continuous bioprocesses (ICB) could impact the future of deviation detection and control.
In its recent responses to FAQs relating to Annex 1, the European Medicines Agency (EMA) discusses bioburden guidelines for good manufacturing practice (CGMP) and good distribution practice (GDP).
The new identity of Suanfarma’s industrial brands signifies integration of its manufacturing sites as part of Suanfarma CDMO.
As part of its acquisition of Catalent, Novo Holdings plans to sell three Catalent fill-finish sites, supporting the growth of the European and US manufacturing capacity.
