Manufacturing

Review of SUT Adoption in Biopharma Manufacturing

The evolution of therapeutic modalities drives the adoption of single-use technologies.

Why Are Pharmaceutical Companies Reluctant to Adopt Cloud Technologies?

Despite its understandable hesitancy, the pharma industry is facing a need for more widespread adoption of cloud-based solutions.

Automating the Future of Fill/Finish

Given the criticality of fill/finish processes, it is clear that automation is the next technological step.

CO2 Incubators

July 01, 2024

The VIOS family of incubators are known for optimal cell growth conditions and minimal contamination risk.

NIPTE Strategy Aims to Mitigate US Pharma Supply Chain Risk

July 01, 2024

The US currently relies heavily on imports from China and other overseas nations for APIs needed to manufacture drug products of critical importance to US patients.

Kite to Evaluate Cellares’ Manufacturing Platform for Wider Use

June 27, 2024

No timetable was given for the length of the planned evaluation or when data would be available, but Kite intends to use the information to expand its manufacturing options.

Novo Nordisk Aims to Invest $4.1 Billion to Expand Manufacturing Capacity in US

June 27, 2024

This $4.1 billion investment to build a second fill/finish manufacturing facility in Clayton, N.C., boosts Novo Nordisk's current 2024 investments in production to $6.8 billion.

Sarepta’s Elevidys for Duchenne Muscular Dystrophy Gets Expanded FDA Approval

June 26, 2024

Sarepta Therapeutics received expanded approval from FDA for Elevidys in the treatment of DMD in non-ambulatory patients as ell as ambulatory patients.

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

June 25, 2024

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

USP and African Institutions Provide Free Access to Pharma Production Resources

June 24, 2024

A new initiative will advance access to quality medicines and vaccines in Africa.

CordenPharma and WACKER Consortium Enters Pandemic Readiness

June 20, 2024

The companies have completed the expansion and qualification phase and now enter a stand-by phase for five years.

Thermo Fisher Opens New Building at Wisconsin GMP Lab

June 19, 2024

The $58 million investment has resulted in a 72,000-square-foot facility with a dedicated LC–MS space and molecular suites and will bring as many as 350 new jobs onto the campus.

FDA Approves Immunoglobulin Therapeutic to Treat Primary Immunodeficiencies

June 18, 2024

Yimmugo, which was introduced in Europe at the end of 2022, could be on the market in the US within months.