Contract Manufacturing, Biopharmaceutical Production

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.

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.

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.

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

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.

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.

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.

The huge potential of biopharma is presenting an important epoch for outsourcing partners that can support the development and manufacture of biologics in an efficient way.

Contract partners must help innovators, especially smaller and virtual companies, consider manufacturability as early as possible in development. This requires focusing on technical and operational performance, as well as cost.

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

The need for manufacturing speed inspires contract manufacturers to explore advanced processing technologies.

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

Karen Flynn rejoins Catalent as president of biologics operations; regional presidents named for US and Europe.

The acquisition expands Charles River’s scientific capabilities in cell therapy development.

New training facilities, laboratories, packaging, gene therapy manufacturing, and biologics manufacturing highlight Thermo Fisher Scientific expansions.

Fujifilm Diosynth Biotechnologies will add a new building, including gene therapy laboratories, to its facility in College Station, TX.

Lonza, through its Ibex Solutions, will now cover preclinical and clinical development and manufacturing for a significant portion of Genmab’s pipeline.

Biotechnology company, Avacta Group, and clinical-stage oncology-focused biotech, ADC Therapeutics, have entered into a collaboration and option agreement focused on the development of potent Affimer-drug conjugates.