The delivery technologies and development solutions provider Catalent Pharma Solutions today announced it has completed a $5.5m expansion program at its 200,000+ square foot Philadelphia, PA.
Pharma must brace itself for production scheduling clashes and cost challenges ahead of next year’s Falsified Medicines Directive (FMD) says PharmSource.
KBI will provide services to ReForm to further develop and validate its biologic formulation platform and in turn, will gain access to ReForm’s proprietary excipient technologies.
The synthetic DNA provider Twist Bioscience Corporation has completed a private placement of $50m to advance its proprietary, silicon-based DNA Synthesis Platform.
CMAB Biopharma has raised $34m in Series B financing to upgrade its GMP facilities – and has entered into collaboration agreements with “several” biopharma clients, says CDMO.
At DCAT Week, contract manufacturing and development companies from across the globe shared updates and news – from multi-million dollar investments to new business structures and areas of focus.
Abzena has completed a remodeling of its new antibody-drug conjugate (ADC) GMP manufacturing suite, which will support customers progressing drug development programs from research into clinical trials.
Grand River Aseptic Manufacturing has purchased a new lot of land to expand its manufacturing capabilities as growth in the market drives demand, says CEO.
Thermo Fisher Scientific says its proposal to move manufacturing and R&D operations from Ashford, Kent to existing sites in Mexico, China and Denmark was a “very difficult decision.”
PCI Pharma Services has validated its former Millmount site to help Ireland’s ‘thriving pharma community’ comply with Europe’s Falsified Medicines Directive.
A lack of generic competition for Pfizer’s contraceptive Depo-Provera has influenced Amphastar’s decision to prioritise its pre-filled syringe version, says executive.
Zelluna Immunotherapy has partnered with the CDMO MasSTherCell to develop its T-cell receptor (TCR) adoptive cell therapy platform with clinical trials expected to begin in 2019.
Partnering with CMOs makes sense for emerging biotechs, says Ardelyx exec James Kanter, who relies on networking and clear communication guidelines to manage third-party relationships.
CDMOs continue to take on a larger role supporting sponsors in the pharmaceutical industry, though new technology and changing requirements could shift the models in which they operate.
The US FDA warnings sent to Chinese and Hong Kong-based firms are the latest examples of OTC makers struggling to comply with pharmaceutical standard GMP.
Grand River Aseptic Manufacturing (GRAM) has purchased a new syringe filler to help meet "the rising demand" for parenteral development and manufacturing services.
The FDA is seeking legal action against a 503B registered outsourcing facility, which is in the process of requesting an emergency hearing to file a restraining order against the agency.
Only marketing authorisation holders, and not CMOs or third-party logistic providers, will be able to report to the European Hub for serialisation compliance, says drug database coordinator EMVO.
BioDuro has acquired Molecular Response LLC and its translational oncology research platform, which includes a biobank of more than 100,000 viable tumor specimens.
A clash between Storm Emma and Arctic temperatures over Ireland has forced the closure of two Takeda sites in Dublin, and Jazz Pharmaceuticals’ Athlone facility.
Regulus Therapeutics has entered into an oligonucleotide synthesis collaboration with STA Pharmaceuticals for research and mid-scale non-GMP/cGMP manufacturing.
CordenPharma has revamped its executive leadership team, Recipharm has named the head of its new global development organization, and several new CEOs have been appointed.
Lonza has increased its encapsulation capacity and invested in highly potent active pharmaceutical ingredient (HPAPI) services at a facility in Tampa, Florida.
Avid Bioservices has been selected to manufacture a commercial drug substance for Enzyvant, a subsidiary of Roivant Sciences, which is developing a therapy to treat Farber disease.
Avid Bioservices expects new contractual commitments in the coming weeks and months after raising more than $20m and completing its transition to a dedicated CDMO, says CEO.
Scientist.com is working to implement an improved contractual landscape ahead of GDPR implementation in May, in order to ensure global compliance among sponsors and CROs.
