Manufacturing

GEA’s plug-and-produce skids are designed for multi-product pharmaceutical and biopharmaceutical separation.

NewAge Industries is adding cleanrooms at its Pennsylvania headquarters.

Sparx Therapeutics will build its first commercial manufacturing facility in Yangzhou, China, for antibody drug production.

Univercells Technologies and VectorBuilder to produce custom viral vectors for cell and gene therapies as well as vaccine applications.

Novasep and Exelixis have signed a manufacturing services agreement for the CGMP clinical manufacturing of a next-generation ADC candidate.

A new media panel, gene kit, and advanced resins that are now in Thermo Fisher Scientific’s gene therapy portfolio aim to reduce manufacturing costs and increase gene therapy viability.

Understanding the process and product goals is just the first step to a holistic approach to process development.

Help prevent contamination in a facility by zone.

The acquisition of Intermountain Life Sciences will double Cytiva’s capacity for buffers and liquid cell culture media at its manufacturing site in Logan, Utah.

The extended manufacturing agreement between Pinteon and Lonza enables future clinical production of PNT001, a novel Tau antibody therapeutic that targets Alzheimer's disease and traumatic brain injury.

Selexis and KBI Biopharma will use integrated services to advance Immatics’ TCR bispecifics drug development program to the IND stage.

New challenges in extractable and leachable studies for cell and gene therapy products.

Catalent expands capabilities for stem cell-based therapies with acquisition of RheinCell’s GMP-grade human iPSCs.

The industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.

HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.

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

Amgen’s greenfield facility near Columbus, Ohio to assemble and package vials and syringes is expected to be operational by 2024.

Thermo Fisher Scientific has introduced its new Quick to Clinic solution, which is designed to accelerate biologic drug development from discovery to the IND phase in a shortened period.

The Cell and Gene Therapy Catapult will establish offices and laboratories in Edinburgh, Scotland.

Genezen Laboratories has broken ground on a new current good manufacturing practice (CGMP)-compliant lentiviral vector production facility.

Reports of myocarditis and pericarditis following Pfizer-BioNTech and Moderna vaccinations prompts warnings.

SP Scientific Products’ SP Hull LyoStar 4.0 R&D freeze dryer supports rapid freeze-dry cycle development, optimization, and process scale-up.

The University of Birmingham has been confirmed as the third National Training Centre in the Advanced Therapies Skills Training Network (ATSTN) initiative

The European Commission has purchased an additional 150 million doses of Moderna’s COVID-19 vaccine for delivery in 2022.

EMA's recent positive opinion for a recombinant vaccine for rabbits developed using Algenex’s proprietary and patent protected Baculovirus vector-mediated expression platform, CrisBio, should push the full commercialization of the platform forward.

Ilya Pharma has been granted approval by the Swedish Medical Product Agency and Swedish Ethical Review Authority for initiation of a Phase II clinical trial of its ILP100 gene therapy.

CureVac’s first-generation COVID-19 vaccine candidate, CvnCoV, did not meet efficacy targets in a second interim analysis.

Recent analysis has shown that two doses of COVID-19 vaccines are highly effective against hospitalization as a result of infection with the Delta variant of COVID-19.

Horiba has joined a consortium aimed at accelerating the development of process analytical technologies for cell and gene therapy manufacturing

Sanofi’s new Pennsylvania facility expands production of Fluzone High-Dose Quadrivalent flu vaccine.