Manufacturing

Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.

Recent CDMO partnerships include COVID-19 collaborations, manufacturing partnerships, service agreements, and a strategic alliance expansion.

The expansion in Le Mans, France will support growth in clinical and commercial manufacturing.

Sterling Pharma Solutions and OncoTEX have entered into a clinical development agreement for the manufacturing of OncoTex’s novel platinum-resistant oncology drug candidate, OxaliTEX, for use in clinical trials.

Lonza plans to invest approximately CHF 850 million (US$936 million) to build new state-of-the-art mammalian manufacturing facilities at its Visp, Switzerland, and Portsmouth, NH, sites.

Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.

Catalent has acquired Promethera Biosciences’ cell therapy manufacturing subsidiary, which includes a 32,400 ft2 facility in Gosselies, Belgium.

AMRI will increase R&D and manufacturing capabilities for orphan and rare disease products.

Vaccine development is inherently challenging; however, in light of the COVID-19 pandemic, innovations have been prioritized, leading to accelerated development processes.

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

Demand for recombinant microorganism-based cell culture supplements is rising on the back of lower contamination risk.

As downstream bioprocessing improvements continue, efforts are underway to integrate downstream processes into continuous operations.

A best practices approach to pharma’s most challenging-to-inspect container.

Packaging materials, kit design, and cold-chain handling should be optimized for each study.

Vetter and Rentschler Biopharma have announced the strengthening of their strategic alliance.

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

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.