Manufacturing

Aseptic spray drying offers a technology alternative to manufacture thermally stable vaccines.

The sensitivity of droplet digital PCR helps manufacturers detect Mycoplasma contamination in AAV-based gene therapy products.

Contract packaging organizations packaging biologic drugs for clinical trials use technologies that meet the unique requirements of each study.

Supply-chain visibility systems are proving their worth in the distribution of COVID-19 vaccines and may see broader use in the future.

Certain therapeutics, such as ophthalmics, must be provided as a sterile dosage form but can pose fill/finish challenges due to the small batch sizes required and the fact that the products used are difficult to fill and of high value.

Blow-fill-seal (BFS) technology presents an economical option for single-unit dose delivery of vaccines.

The latest news about biologics facilities includes various expansions, new locations, and acquisitions in the bio/pharmaceutical space.

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

The expansions will add peptide manufacturing capacity.

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.

The semi-automated TipFil Syringe Filler from TurboFil Packaging Machines provides accurate and consistent fills.

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.

Researchers from the United Kingdom, have identified a new additive manufacturing method that enables the 3D printing of medicine in highly porous structures.

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.

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.

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.

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

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.