Outsourcing

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.

Manja Boerman tapped as president of Cell & Gene Therapy for Catalent with retirement of Pete Buzy.

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.

Characterizing and controlling protein aggregation is vital to ensure safety and efficacy of a biopharmaceutical product. In this interview, important aspects of protein aggregation and the tools available to address this issue are discussed.

Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.

More sustainable and functional packaging protects temperature-sensitive drugs.

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.

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.

As compounds become more complex in nature and biological ingredients are more widely used, stability testing approaches must follow suit and provide flexibility for developers.

Contract service organizations can offer biopharma companies early insight into dangers that may hinder a drug’s later development.

Under the agreement, ERS Genomics will license its gene-editing technology to Aelian Biotechnoloy to support its commercial functional genomic screening platform.

The need for lyophilization services is growing as a burgeoning pipeline of new biologics matures.

How to adopt win-win strategies and understand quality agreements for complying with cGMP when building strategic relationships with pharmaceutical contract research organizations.

Technology and capacity investments create opportunities in the cell and gene therapy arena for CDMOs and biopharma alike.

As cell and gene therapies become more prominent, industry is seeking the expertise and capabilities of outsourcing partners to ensure success.

Contract partners must help innovator biotechs 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.

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.

Catalent’s FlexDirect service offers sponsors multiple delivery options from a single inventory.