Manufacturing

Celonic will manufacture CvnCoV at its facility in Germany.

The partnership will combine Cold Chain Technologies thermal packaging with B Medical Systems’ stationary refrigeration solutions for temperature-critical pharmaceuticals.

The company has entered into an agreement with the African Vaccine Acquisition Trust for the supply of 220 million doses of its single-shot COVID-19 vaccine for the African Union’s 55 member states beginning in the third quarter of 2021.

EMA has approved the manufacturing of drug product for BioNTech’s COVID-19 vaccine, BNT162b2, at BioNTech’s manufacturing site located in Marburg, Germany.

The agency’s human medicines committee has approved new manufacturing sites for COVID-19 vaccines.

The companies will aim to establish clinical and commercial supply agreements for Plus Therapeutics’ RNL-liposome drug product at the appropriate stage of development.

The fund will focus on emerging life science companies with novel platforms and methods to improve therapeutic outcomes and those with technologies that support science research, development, and manufacturing.

After releasing US Phase III trial data for AZD1222, more questions have been raised with AstraZeneca concerning potentially outdated information that could provide an incomplete view of efficacy.

To maintain business continuity and employee safety during the pandemic, many companies have begun tracking and maintaining records of employee health information.

The new facility, which is expected to be operational by spring 2025, will feature 8 x 20,000-L bioreactors with the potential to add further 24 x 20,000-L bioreactors based on market demand.

Romaco, supplier of processing and packaging equipment, has acquired STE Tecpharm, S. L., a Spanish manufacturer of processing technology.

Using the capabilities of Pharma Waldhof, one of Aceto’s facilities in Düsseldorf, Germany, the company plans to provide customers with access to raw materials, tested products for pharmaceutical cell culture applications, and cell culture media ingredients.

Under an expanded agreement with J&J, Catalent Biologics will increase manufacturing capacity at its Anagni, Italy, site to accommodate the large-scale commercial supply of Janssen’s COVID-19 vaccine.

The transaction is set to close during the first half of 2021 and is expected to enhance drug substance and drug product capabilities for WuXi.

The companies will use capacity at IDT previously reserved for Takeda’s dengue vaccine candidate, TAK-003, to manufacture Janssen Pharmaceutical’s single-shot COVID-19 vaccine.

Many biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.

Extrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.

Lonza will provide a manufacturing suite at its facility in Houston, TX, for the clinical and commercial production of AdCOVID, Altimmune’s single-dose intranasal vaccine candidate.

WuXi will produce SARS-CoV-2 s-proteins for BioVaxys’ COVID-19 vaccine candidate, BVX-0320, and for its Covid-T immunodiagnostic program.

Smart packaging opens doors to new products for diagnosis and treatment of eye problems.

Continuus Pharmaceuticals is building the first GMP facility using integrated continuous manufacturing technology for end-to-end production of small-molecule APIs and finished dosage forms.

Currently, supporters of the plan include the governments of Germany, Norway, and Ethiopia; Wellcome and the Bill and Melinda Gates Foundation; the World Economic Forum; and WHO, Gavi, and UNICEF.

This agreement enhances GSK’s investment in cell and gene therapy manufacturing in the UK for clinical trials.

TurboFil’s CrimpTech Series includes semi- and fully automatic machines.

The investments are expected to double Thermo Fisher’s manufacturing capacity while creating more than 1500 jobs at 11 manufacturing sites in the Americas, Europe, and Asia.

The expansion plans to increase Vectura’s DPI dosage form development, specifically its unit dose and multi-dose inhalers, and integrated device design and manufacturing for customer programs.

Rokote Laboratories Finland, an academic spin-out located in Finland, is working to develop a nasal spray vaccine against COVID-19 based on research from the University of Helsinki and the University of Eastern Finland.

The expansion will allow Ashland to focus on clinical study projects and commercialization activities.

USP is collaborating with Phlow to build a new lab that will develop test methods and standards to facilitate broader adoption of continuous manufacturing.

Manufacturing of the vaccine will take place at Baxter’s fill/finish sterile manufacturing facilities located in Bloomington, IN.