Cellectar Biosciences has announced a partnership with the Centre for Probe Development and Commercialization (CPDC) to establish manufacturing capacity ahead of the company’s NCI-supported Ph II trial of CLR 131.
The FDA is still in “the early stages” of overseeing 503B outsourcing facilities, but efforts continue as concerns surround the oversight of drug compounders, according to a recent report by the US Government Accountability Office (GAO).
Ideal Cures has added a fourth manufacturing location at Sikkim in India to meet the demand of its local customers and to expand its global customer base.
Plans to build a five-story biomanufacturing plant in Ireland could be shelved following the clinical failure of Pfizer's proposed cholesterol-lowering candidate bococizumab.
A written quality agreement between a sponsor and a contract manufacturer can facilitate compliance with cGMP, the US FDA says in its finalised guidance.
The acquisition of a stick sachet packaging line from Merz expands Almac Group’s MHRA/FDA-approved UK commercial packaging facility to meet the growing demand for specialist packing solutions.
Continuous manufacturing and sterile production innovations have dominated requests to participate in the US FDA’s Emerging Technology programme, the Agency says.
Larger CMOs are likely to be better for commercial manufacturing but small players offer niche services and agility for lower volumes, say Symbiosis and Idifarma.
Thermo Fisher Scientific has provided Rutgers’ researchers with hot-melt extrusion tech to support development of continuous manufacturing for drug production.
Saneca Pharma will invest in its manufacturing site in Slovakia to service a five-year agreement supplying the Menarini Group with controlled release pellets.
Analysts suggest a Trump presidency won’t have a material impact on contract research organizations – though a shake-up in trade policy could complicate the larger, global pharmaceutical industry.
Pfizer has earmarked two sites in the UK for closure, including an ex-Hospira aseptic plant in London it says would need ‘significant investment’ to remain open.
Adents and Microsoft have introduced a new platform that allows contract manufacturing organizations (CMOs) to leverage data generated during the serialization process.
Increasing demand for reduced particle loads in pharmaceutical containers has driven Datwyler to build a CHF 100m plant making elastomer components for injectable drug delivery systems.
Smaller drugmakers are shifting away from generics and towards niche new molecules says Recipharm, which has expanded a small-scale API facility to feed demand.
Agilent Technologies has contracted the original creators of its RapidFire 365 High-throughput Mass Spectrometry System to further develop new applications.
South Korea is a key opportunity for biopharma services firms says Thermo Fisher, reporting its third quarter which saw it up capabilities in the region.
Almac Group’s Diagnostics business will engage with pharma to validate the link between its immune response assay and checkpoint inhibitor based therapy.
A newly opened training centre in Leeds, UK will help fulfil demand for skilled workers in the drug production space, says the head of process manufacturing.
CMC Biologics and IDT Biologika have added Cerbios-Pharma SA and Oncotec Pharma Produktion GmbH to the companies’ PROVEO Partnership – a strategic collaboration for manufacturing antibody drug conjugates (ADCs).
Danaher Corporation will further extend its presence in the life sciences space through the acquisition of separations and purification firm Phenomenex.
AstraZeneca will supply Toprol-XL to Aralez Pharmaceuticals Trading for at least 10 years after selling the US rights to the off-patent beta blocker for $175m.
Germany’s Merck has opened a bioprocessing collaboration centre in Songdo, Incheon - the latest investment supporting the burgeoning Korean biopharma industry.
UK-based contract manufacturers are benefitting from the weak pound following the country’s referendum in June, but the long-term impact of Brexit is still unknown.
Lonza and Boehringer-Ingelheim dominate the consolidated biologics CMO space but disposable technologies and improved yields are beginning to change this, says PharmSource’s Jim Miller.
Economics, regulatory inexperience and a lack of technical skills are holding back drug industry adoption of continuous manufacturing says CMAC industrial director, Craig Johnston.
Alcami has announced its first to market Protect Your Brand™ offering, which it said will support companies looking to implement a backup supply option.
Being geographically close to customers reduces excipient costs and timelines says Colorcon, as it prepares to open the doors at its first South American production plant.
