Manufacturing

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.

Smart packaging opens doors to new products for diagnosis and treatment of eye problems.

Continuus Pharmaceuticals is building the first GMP facility using integrated continuous manufacturing technology for end-to-end production of small-molecule APIs and finished dosage forms.

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

TurboFil’s CrimpTech Series includes semi- and fully automatic machines.

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.

USP is collaborating with Phlow to build a new lab that will develop test methods and standards to facilitate broader adoption of continuous manufacturing.

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

In a pandemic, genetic vaccines offer several advantages over traditional approaches.

A digital system makes real-time inventory, production, distribution, and shipping information readily accessible.

Integrated, paperless data systems can improve efficiency and quality.

The need for real-time monitoring and control has spurred the development of new analytical tools.

AstraZeneca has announced that the mass rollout of its COVID-19 vaccine has begun via the COVAX initiative.

The rapid and efficient delivery of innovative treatments through the COVID-19 pandemic has demonstrated the value of collaborations within the bio/pharma industry.

The COVID-19 pandemic is pushing more companies to adopt just-in-time practices, but success demands careful upfront risk assessment and planning.

More work is needed to ensure the rising demand for cell and gene therapy manufacturing capacity and required skilled workforce can be met in Europe.

Distribution of the first one-dose vaccine for COVID-19 to start in early March.

Currently, the facility manufactures products for oral diabetes treatment and will be expanded to increase capacity for these products.

The expansion, to be completed in April 2021 aims to increase the CDMO’s viral-vector production capacity in Spain.

Understanding difficulties that can occur during manufacture and resolving them quickly can improve oral solid-dosage drug production.

Aprecia's compression-free 3DP manufacturing platform and Glatt’s multiparticulate technologies offer solutions to pharmaceutical dosage design challenges.

The second phase of the Myford facility expansion in California will add upstream and downstream processing suites.

The deal expands Wavelength’s drug substance manufacturing footprint and its API CDMO business.

Through the agreement, Catalent will manufacture LUPKYNIS (voclosporin), Aurinia’s drug for the treatment of adult patients with lupus nephritis, at its pharmaceutical softgel center of excellence in St. Petersburg, FL.

Cascade began production on new facilities to manufacture APIs for clinical and commercial GMP production.

The companies have expanded their existing partnership to include 40 Million Doses of COVID-19 vaccine for South Korea.

The acquisition will integrate drug substance, drug product, and clinical testing capabilities under Quotient.

Integration of Brooks Life Sciences BioStore III automated storage and inventory monitoring solution with Cytiva’s Chronicle software will improve traceability, process control, and monitoring capabilities.

Collaboration between equipment suppliers and users is leading to innovation and optimization in biopharmaceutical manufacturing.

Labeling, printing, and on-dose tagging technologies provide a multi-layered approach to anticounterfeiting for pharmaceuticals.