Manufacturing

ADMA will now have the ability to produce Bivigam at an expanded capacity with the same manufacturing scale, while using the same equipment, release testing assays, disposables, and labor force.

AkesoBio’s expanded manufacturing capacity, enabled by the addition of another Cytiva FlexFactory platform, will be used to meet current and future market needs in China as well as worldwide.

In addition to the traditional FOYA category awards, ISPE recognized two facilities for operational agility during the COVID-19 pandemic.

With a $5 million grant from DARPA, DNA Script and Moderna will develop a prototype for rapid mobile manufacturing of vaccines and therapeutics as part of the DARPA’s Nucleic Acids On-Demand World-Wide program.

Samsung and TG Therapeutics have expanded their 2018 contract manufacturing deal for the supply of TG’s ublituximab, an investigational anti-CD20 monoclonal antibody.

DCAT’s annual bio/pharmaceutical development and manufacturing business event, DCAT Week, will take place virtually from July 12–16, 2021, with the in-person even postponed to March 20–24, 2022 in New York City.

Design for a new BMS multi-product cell therapy manufacturing site in Leiden is underway, with construction to start later in 2021.

Vertex and CRISPR have amended their collaboration agreement to include the development, manufacture, and commercialization of CTX001, an investigational CRISPR/Cas9-based gene editing therapy for sickle cell disease and transfusion-dependent beta-thalassemia.

Post-inspection report reveals nine sanitary and process problems at Bayview, Md., facility.

CalAmp's new sensor for cold-chain applications provides visibility for shipping vaccines.

Pending a completed FDA inspection, Emergent BioSolutions halts manufacture of vaccine drug substance at Maryland facility.

CordenPharma’s expansion will include the addition of new production lines which will be merged into the lipid manufacturing process in April 2021.

Sartorius has expanded in the United Kingdom with the relocation to a new facility in Havant, Hampshire, for downstream processing equipment.

The new Abzena facility will initially include four modular suites with up to two 2000-L bioreactors, followed by the addition of two more 2000 L suites.

The ATMPS and Ori Biotech collaboration aims to improve visibility and reporting of cell and gene therapy manufacturing through a pre-integrated data solution.

Catalent’s new mammalian cell culture suites in Madison, Wis. use single-use bioreactor systems for CGMP clinical and commercial manufacturing.

The China National Medical Products Administration has given the company the green light to begin manufacturing commercial supply of its approved anti-PD-1 antibody, tislelizumab, at its biologics facility in Guangzhou, China.

The UK's National Horizons Centre has been confirmed as a National Training Centre that will deliver on-site advanced therapies and vaccine manufacturing specific training.

Biopharmaceutical companies and contract manufacturers respond to changing demand dynamics for upstream bioprocessing capacity.

A series of minute virus of mice spiking studies were performed with a monoclonal antibody product and small-scale AEX membrane adsorbers to evaluate a range of critical processing conditions.

The adoption of single-use technologies in fluid-handling systems helps streamline downstream bioprocessing operations.

Breakthroughs in analytics and alternatives to traditional freeze drying promise to reshape biological development and the cold chain.

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.

AstraZeneca has released the results of its primary analysis of the Phase III trial data evaluating its 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.

A growing pipeline of gene therapy candidates aimed at treating neurodegenerative diseases has prompted new guidance.

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

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.

With funding from the federal government, Merck will expand capacity to produce J&J’s COVID-19 vaccine.