Contract Manufacturing, General

The early success seen on the market for approved cell and gene therapies poses both technical and manufacturing challenges for pipeline candidates on the road to commercialization.

Contract service providers offer vital services to bio/pharma companies of all sizes. Establishing an effective working relationship and managing operations are key to avoiding compliance issues.

Sterling Pharma Solutions has signed a deal with Moleculin Biotech to support the development of WP1122, a potential COVID-19 treatment.

Catalent has unveiled plans to invest in a European center of excellence for clinical biologics formulation development and drug product fill/finish services at its facility in Limoges, France.

The acquisition will give the CDMO additional clinical filling options in Europe, which is expected to come online in 2021.

The new facility in Grand Rapids, MI, is part of the CDMO’s aggressive expansion plan.

Demand for custom drug delivery solutions is increasing and bringing forth an exciting period of valuable, innovative development opportunities.

The COVID-19 pandemic has created a rise in demand for R&D and a shift in focus for some contract organizations.

Cambrex has invested in an expansion of its flexible manufacturing facility in Sweden, which will increase the company’s flexible drug substance manufacturing capacity.

Cobra Biologics has signed a supply agreement to provide GMP manufacturing for AstraZeneca’s AZD1222 COVID-19 vaccine candidate.

CordenPharma announces expansion of lipid excipients supply for coronavirus vaccine scale up.

Agreements with the PolyPeptide Group and AGC Biologics will scale up production of the Novavax Matrix-M adjuvant.

The companies have entered into a manufacturing agreement for the fill finish supply of lenzilumab for the potential treatment of COVID-19.

CordenPharma and Moderna extended a strategic manufacturing services agreement for the supply of lipid excipients to be used in Moderna’s vaccine against SARS-CoV-2.

Advent manufactured the vaccine doses for the Phase 2/3 clinical trial.

HHS announces $354 million in funding for private industry to manufacture generic drugs in the US from raw materials to finished product.

Vibalogics is contracted to manufacture Janssen's COVID-19 candidate vaccine at its GMP-accredited facility in Cuxhaven, Germany.

Hitachi Chemical Advanced Therapeutics Solutions and apceth Biopharma entered into long-term development and manufacturing services agreements for the clinical and commercial supply of multiple bluebird bio therapies.

CMO Evonik begins capacity expansion of APIs and intermediates at its sites in Dossenheim and Hanau Germany to increase EU supply security for drug products.

FDA approved hydroxychloroquine sulfate for emergency use as a treatment for some hospitalized patients with COVID-19.

Fujifilm allocates production volumes for COVID-19 treatments in 2021 at its Denmark facility.

The goal of the collaboration is to manufacture up to one billion does per year of mRNA-1273, Moderna’s vaccine against the novel coronavirus.

Catalent and Johnson & Johnson announce joint investment and tech transfer to prepare for rapid scale-up and segregated cGMP commercial manufacturing capacity.

Wavelength Pharmaceuticals expanded production of APIs for certain pharmaceutical products needed to manage respiratory critical care patients in the COVID-19 pandemic.

Catalent Biologics increased capacity at its Bloomington, IN Facility.

The company will build an additional commercial-scale, contract manufacturing facility for viral vectors and gene therapies near its existing site in Carlsbad, CA.

Civica Rx plans redundant manufacturing capacity to relieve and prevent shortages of generic, sterile injectable drugs.

Considering the potential interaction of a drug with the delivery device early on in in development is integral to achieving the best combination.

The new molecules entering the development pipeline are bringing forth exciting challenges in drug delivery.

Civica Rx plans redundant manufacturing capacity to relieve and prevent shortages of generic, sterile injectable drugs.