Manufacturing

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.

Yposkesi is building its second commercial facility for cell and gene therapy manufacturing at its campus on Corbeil-Essonnes, France.

Optima has teamed up with the Robert-Bosch-Krankenhaus and Heidelberg University to develop a unit for decentralized, automated production of CAR-T cell therapies.

Novavax’s COVID-19 vaccine is 90.4% effective and maintains efficacy when administered with an influenza vaccine.

The CGT Catapult has formed a consortium aimed at advancing the technology development and lowering costs of cell and gene therapy manufacturing.

The vaccine is now authorized for ages 12 and older in European Union member states and the UK.

VIVEbiotech has opened its new lentiviral vector manufacturing facilities in Spain, expanding capacity for lentiviral vectors for use in cell and gene therapies.

AGC Biologics has partnered with BioNTech to further supply plasmid DNA starting material from its Heidelberg, Germany, facility for the Pfizer-BioNTech COVID-19 vaccine.

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

The Module Type Package standard is now supported in Emerson’s DCS and PLCs.

Currently, PNI offers a Genetic Medicine Toolkit, including its GenVoy LNP delivery platform and NanoAssemblr microfluidic-based nanoparticle manufacturing platform, for the development of genetic medicines.

The emergence of new biotherapeutics is both the driver and result of innovative drug development technologies.