Manufacturing

Complex formulations, personalized medicines, COVID-19 therapies, and sustainability goals are driving innovations in drug packaging.

Aprecia and Glatt investigate manufacturing technologies to widen the formulation design space for oral delivery.

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

Despite the COVID-19 pandemic, the industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.

Aber Instruments launched its new Futura neotf single-use biomass sensor for process fingerprinting for on-line monitoring and control of cell culture.

The European Medicines Agency and the European Centre for Disease Prevention have joined forces in a new initiative aimed at strengthening the post-marketing surveillance of COVID-19 vaccines in Europe.

ViroCell will supply viral vectors and gene modified cells, to academic and corporate clients, for translational cell and gene therapies going into clinical trials.

Moderna’s investments will double the formulation fill/finish and drug substance manufacturing of its vaccine to up to three billion doses in 2022 at various manufacturing sites.

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.

Avantor plans to increase its single-use manufacturing footprint by 30% and double its cleanroom space in the US and Europe.

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.

Sanofi will perform the fill/finish of up to 200 million doses of Moderna’s COVID-19 vaccine at its Ridgefield, NJ, facility starting in September 2021.

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

Lonza’s new complex will occupy 2000 m2 of the facility with six levels of manufacturing space and will provide room for future small-molecule technologies expansion.

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.

The decision comes from the US CDC Advisory Committee on Immunization Practices following the evaluation of data showing a rare adverse event involving blood clots in combination with low platelet counts within approximately one to two weeks following vaccination.

Executives that participated in the CPhI post-pandemic survey are predicting a push for repatriation of manufacturing globally.

Lipid production at Evonik’s Hanau, Germany, site was set up in eight weeks and met high-quality requirements, accelerating delivery time, which was originally set for mid-2021.

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

The collaboration will evaluate Nanoform’s fast dissolution nanoparticles in Aprecia’s ZipDose 3DP technology platform for buccal and oral drug delivery.

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.

The new facility, which will be Evotec’s first in Europe, will aim to offer capacity, flexibility, and quality for biotherapeutic development and manufacturing while utilizing technology that employs small, automated, highly intensified, and continuous bioprocessing operations inside autonomous cleanrooms.

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

The additional doses are a result of the European Commission’s expanded advance purchase agreement, which brings the total number of doses delivered to the EU to 600 million.

Material properties play a role in container closure integrity under frozen or cryogenic storage temperatures.

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

Drug product security requires anti-counterfeiting techniques such as authentication throughout the supply chain.