Contract Manufacturing, Biopharmaceutical Production

Evonik offers lipid nanoparticles for gene-based drug development and manufacturing.

The new super plant, being built in Incheon, South Korea, will have a total biopharmaceutical manufacturing capacity of 256,000 L.

The companies have formed a long-term manufacturing agreement to accelerate the global supply for Lilly’s COVID-19 antibody therapeutics.

The agreement will provide capacity for the manufacturing of AZD7442, currently being developed for the potential prevention and treatment of COVID-19, at Lonza's Portsmouth, NH site.

The investment at its Madison, WI, facility will expand MilliporeSigma’s capacity for high-potent active pharmaceutical ingredient production and allow for continuous flow manufacturing of ADCs.

The company is investing $130 million to add Phase III through commercial-scale manufacturing suites to its gene therapy campus in Harmans, MD.

Rapid scale-up to billions of doses requires collaborative, all-out efforts by innovators, their manufacturing partners, and the entire supply chain.

Cellular and gene therapy fields are currently on track for, if not already experiencing, a serious capacity crunch.

CDMO Avid Bioservices will provide development and drug substance manufacturing for Oragenics’ novel COVID-19 vaccine candidate, Terra CoV-2.

The company has made several moves in recent weeks to expand manufacturing capacity and cell line services.

Fujifilm Diosynth Biotechnologies’ North Carolina site will be used to manufacture Novavax’ NVX‑CoV2373 vaccine candidate for a Phase III clinical trial.

Catalent has unveiled investment plans to create a European center of excellence for clinical biologics formulation development and drug product fill/finish services.

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

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

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

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.

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.

But are innovations sufficient to increase adoption? CMOs are demanding better continuous bioprocessing options.

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

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.

Pre-clinical immunization studies of iBio’s SARS-CoV-2 VLP candidates are being performed by Texas A&M.

AzarGen’s biosimilar, made in iBio’s plant-based system, will be compared to the original molecule in pre-clinical studies.

Emergent BioSolutions will help develop and manufacture an oral vaccine candidate and will develop plasma-based antibody therapeutics.

Belgian-based bioprocessing provider, Univercells, has launched a CDMO, Exothera, that will support developers of cell and gene therapies through process development and production of viral vectors.

FDA issued a notice to drug compounders regarding the transition of licensure of biologics to the Public Health Service Act.

Catalent builds on its investment in cell and gene therapy development and manufacturing with the acquisition of MaSTherCell Global.

CDMOs and CMOs will continue to invest in biopharmaceutical services and facilities as the bio/pharmaceutical industry looks to biosimilars and personalized medicine.