Outsourcing

CDMO Yposkesi will increase its current gene therapy vector capacity through French government’s “Plan de Relance” scheme.

The companies will utilize the Cocoon Platform for clinical point-of-care manufacturing.

The companies have entered into an agreement to develop processes for a novel immunotherapy protein.

Centrient started production at its new statins API manufacturing unit in Toansa, India.

Vectura has signed an agreement with Incannex Healthcare for the pre-clinical development of IHL-216A, an inhaled drug product for the treatment of traumatic brain injury.

Thought and foresight into method development stages can ensure costly errors and delays are avoided later on.

VIVEbiotech has opened its new lentiviral vector manufacturing facilities in Spain, expanding capacity for lentiviral vectors for use in cell and gene therapies.

AGC Biologics has partnered with BioNTech to further supply plasmid DNA starting material from its Heidelberg, Germany, facility for the Pfizer-BioNTech COVID-19 vaccine.

MedPharm’s new facility for process development and small-scale manufacturing is in North Carolina, near its existing R&D center.

Automation offers benefits for sterile manufacturing in 503B outsourcing facilities.

Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and development time efficiencies.

The sensitivity of droplet digital PCR helps manufacturers detect Mycoplasma contamination in AAV-based gene therapy products.

Contract packaging organizations packaging biologic drugs for clinical trials use technologies that meet the unique requirements of each study.

Certain therapeutics, such as ophthalmics, must be provided as a sterile dosage form but can pose fill/finish challenges due to the small batch sizes required and the fact that the products used are difficult to fill and of high value.

Breakthroughs in analytics and alternatives to traditional freeze drying promise to reshape biological development and the cold chain.

Mass spectrometry and automation are growing in importance for protein characterization, but further improvements are still needed.

Executives that participated in the CPhI post-pandemic survey are predicting a push for repatriation of manufacturing globally.

Post-inspection report reveals nine sanitary and process problems at Bayview, Md., facility.

Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.

Following a manufacturing mix-up, J&J will extend its oversight at Emergent’s Maryland facility; AstraZeneca manufacturing to relocate.

Intensified and distributed manufacturing approaches create flexible, local capacity.

The availability of materials is a critical factor when it comes to vaccine capacity.

SGS is supporting Selecta Biosciences and Asklepios BioPharmaceutical with the Phase I dose-escalation trial of SEL-3999, an AAV8 vector capsid containing no transgene with ImmTOR.

Celonic will manufacture CvnCoV at its facility in Germany.

Stelis Biopharma has closed its Series B and Series C fundraise for US $195 million, which will be used to progress the company’s growth initiatives and help scale its business.