Outsourcing

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.

Catalent will manufacture a mRNA-based COVID-19 vaccine for clinical trials and potential commercialization.

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

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

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.

Private equity firm, Ampersand Capital Partners, has made a majority investment into contract packaging organization (CPO), Tjoapack.

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.

The guidance document describes the agency’s temporary policy for the compounding of drugs during the COVID-19 pandemic.

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

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.

More sustainable and functional packaging protects temperature-sensitive 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.

Risk assessments, audits, and good communication between sponsor and supplier are key elements of supplier oversight.

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

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

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.

Understanding of scale-up parameters and use of process analytical technology are important to meet demand for larger batch sizes.

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.

Assays can provide a useful tool in determining the potential toxicity of drugs throughout the development cycle.