Manufacturing

The acquisition of uniQure’s Lexington, Mass., manufacturing operations will boost Genezen’s late-phase and commercial gene therapy development and manufacturing services.

The increased demand for biopharmaceutical products is increasing the demand for lyophilization innovations and services.

HCPs are major process-related impurities that must be monitored throughout biologics production for clearance.

This collaboration aims to support and accelerate clinical development of advanced and novel technologies.

Webinar Date/Time: Thu, Jul 25, 2024 11:00 AM EDT

The ROSS Model HSM-405SC-25 Inline High Shear Mixer features a built-in workbench and is designed for production floors that require flexibility.

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

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.

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.

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

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

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

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

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.

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

Nadia Sellami, PhD, global segment lead for gene and cell therapy at PacBio, talks about long-read sequencing for cell and gene editing in a video interview.

John Bertagnolli, vice-president of Commercial Operations at Selkirk Pharma, discusses considerations when building and scaling up pharmaceutical facilities, including contamination control and aseptic processing challenges.

Ecolab Life Sciences and Repligen have launched a new affinity resin, DurA Cycle, for large-scale biologics manufacturing.

Key information is needed for excipients and their potential impact on continuous manufacturing processes.

Leveraging automation advancements can help improve efficiency in aseptic processing and speed up commercialization of critical drug products.

Syngene's new production platform offers rapid protein synthesis with lower risk.

The completed expansion at AGC Biologics'Copenhagen, Denmark, site, doubles the company's single-use bioreactor capacity for mammalian-based services.

Syntegon will expand its processing and packaging by acquiring the Spanish equipment supplier.

USP and FDA publish reports detailing drug shortage numbers and challenges through 2023.