Manufacturing

BioIVT opened new cleanroom manufacturing space, using Germfree’s technology to boost its capabilities for cell and gene therapy development.

The new additions to the company’s equipment at its early phase clinical manufacturing facility in Oregon will allow for cleaning, filling, capping, and sealing, and also detecting defects in drug products.

Manual and automated inspection technologies have their own advantages and limitations.

Freudenberg Medical has introduced custom single-use assemblies for silicone extrusion and molding for biopharma applications.

Webinar Date/Time: Thu, Aug 29, 2024 11:00 AM EDT

Innovative solutions are making personalized cell and gene therapies accessible to all.

The ROSS FDA-3500 dual shaft mixer is equipped with independently controlled drives and is designed to efficiently produce good turnover and impart shear to a viscous batch.

The NexGen Press 45 is the latest member of GEA Pharma & Healthcare’s NexGen Press line of tablet presses.

Syngene’s protein production platform uses a cell line and transposon-based technology licensed from Switzerland-based ExcellGene.

Scorpius Holdings is set to launch its first CGMP manufacturing campaign at its San Antonio, Texas, facility for mammalian cell culture in the 2024 third quarter.

BeiGene has opened its new $800 million Hopewell, NJ-based biologics manufacturing facility, which also houses the company's clinical R&D capabilities.

Univercells and the University of Pennsylvania are expanding their collaboration to evaluate certain bioreactors with the aim to scale up gene therapy manufacturing.

PluriCDMO, Pluri's newly launched CDMO division, has been selected by Kadimastem to manufacture two novel cell therapy product candidates.

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.

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.