In batch production, efficient exception management means reducing the time required to identify, review, and resolve process exceptions. Incorporating review by exception functionality within manufacturing execution system (MES) software can streamline biopharmaceutical product release.
Oncologist Stephen Hahn has been nominated for the top post, following the appointment of Brett Giroir as acting commissioner.
In a statement, Janet Woodcock MD, director of FDA’s Center for Drug Evaluation and Research, highlighted the agency’s efforts to enhance the efficiency of postmarket drug safety surveillance.
Scientists from the University of Texas Medical Branch in Galveston and Profectus BioSciences of New York have developed the candidate quadrivalent VesiculoVax vaccine, an investigational vaccine that protected monkeys against four types of hemorrhagic fever viruses endemic to overlapping regions in Africa.
The new addition will also launch a single-use bioreactor for the 93,000-ft2 facility.
The companies plan to promote and manufacture Maverick, an emergency-use, cartridge-based auto-injector.
The transaction is expected to be finalized in early 2020.
GE Healthcare Life Sciences will supply Akeso Pharmaceuticals with the FlexFactory platform to accelerate production of antibody drugs in the Guangzhou region.
Through the agreement, Samsung will provide flexible business terms while offering full regulatory support and improved batch release from small to large scale.
The technology is set to heighten the company’s GPEx expression platform through the utilization of a glutamine synthase knock-out Chinese hamster ovary cell line.
The company will invest $24 million into its Inchinnan, Scotland, site to expand global bioproduction capabilities with additional large-volume liquid manufacturing capacity for cell-culture media.
Schott will combine its adaptiQ platform with West’s Ready Pack system.
The winners were announced during day one of CPhI Worldwide.
FDA report says drug shortages are underappreciated and patients pay a price.
Several factors must be considered when reformulating APIs for pediatric, geriatric, and other specialty patient populations.
Despite preparative work by the bio/pharma industry, any Brexit scenario will result in regulatory implications and increased costs.
After years of discussions around pricing, UK governmental bodies and Vertex have finally reached an agreement on cystic fibrosis treatments.
Companies are facing a huge undertaking to be able to complete risk evaluations of all medicines containing chemically synthesized APIs by March 2020.
On the last day of CPhI Worldwide (Thursday Nov. 7, 2019), several experts will examine the potential role of three-dimensional printing within medicines, particularly in light of the shift in the industry from volume to value.
Avantor’s Senior Vice-President of Business Development and Commercial Operations (Claudia Berrón) will be presenting trends in raw material data mining and sharing within biopharma on the last afternoon of CPhI Worldwide (Thursday Nov. 7, 2019).
On Wednesday Nov. 6, 2019, Dr. Derek Duncan from Lighthouse Instruments will summarize the current state of container closure integrity testing (CCIT) in the bio/pharma industry and will outline a framework for the development of a holistic testing strategy.
Contract development and manufacturing organization (CDMO), Sterling Pharma Solutions, has revealed its investment of $1.5 million into a phased expansion of its facility based in North Carolina, United States.
A number of experts will be examining investment opportunities within the evolving cell and gene therapy sector, in a panel discussion on Wednesday morning (Nov. 6, 2019) during CPhI Worldwide in Frankfurt, Germany.
Swiss-based company, BioVersys, has been granted funding worth up to $8.92 million by CARB-X to support the development of anti-virulence small molecule drugs that disarm bacteria, which could offer a paradigm shift in antimicrobial resistance (AMR) therapy.
The second part of CPhI’s annual report has projected that the biologic manufacturing capacity of Europe will exceed that of the United States by 2023, as a result of the rising number of commercially approved biologics.
Dassault Systèmes has announced the completion of its acquisition of Medidata Solutions, which will connect the 3DEXPERIENCE platform with a clinical trial platform and opens up virtual twin experiences for healthcare.
Intertek has announced that it has expanded its center of excellence for biopharmaceutical services in Manchester, United Kingdom, to support the development of biologics and gene therapies.
According to the third part of the CPhI annual report, a lack of cell and gene expertise may be a drag factor on the sector and a spike in biological therapeutics development is driving bio demand in China.
Start-up company, SeraNovo, has revealed that it has signed a license agreement with Carna Biosciences to expand the existing collaboration and jointly develop an oral formulation of Carna’s kinase inhibitor with increase bioavailability.
Published on Oct. 29, 2019, the study focuses on the multidrug-resistant bacterium Pseudomonas aeruginosa (P. aeruginosa) and how it can be used to develop new and sustainable antibiotic treatments.