Latest Headlines
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Sano Chemicals Announces First-In-Class Fungicidal Agent To Begin Phase 1 Clinical Trials
2/12/2024
Sano Chemicals announced the start of a Phase 1, first-in-human clinical trial, of Occidiofungin, a new chemical entity under development as a treatment to cure recurrent vulvovaginal candidiasis (RVVC).
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CDMO Alcami Adds New Sterile Fill/Finish Line And Two Lyophilizers At South Carolina Drug Manufacturing Facility
2/9/2024
Alcami Corporation ("Alcami"), a leading contract development and manufacturing organization (CDMO), today announced the strategic expansion of its sterile fill/finish manufacturing capacity with the addition of a new sterile fill/finish line with isolator and two lyophilizers at its existing Charleston, SC manufacturing campus. The new state-of-the-art, fully automated GMP sterile filling line offers the flexibility to fill liquid and freeze-dried vials under isolator technology to minimize the potential for contamination, providing the capacity and scalability for clinical and commercial needs and is fully integrated with the company's network of formulation development, packaging / labeling, lab services and pharma storage and services facilities.
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CURIS System And AST Unite To Redefine Aseptic Fill-Finish Processing Technology
2/5/2024
CURIS System, an innovator in advanced decontamination technology, and AST, a leader in aseptic fill-finish processing technology, today announced a groundbreaking partnership. This collaboration marks a significant step forward in the pharmaceutical manufacturing industry, as the two companies combine technology to revolutionize the biodecontamination of aseptic fill-finish isolators using CURIS's disruptive vapor decontamination technology.
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Novo Holdings To Acquire CDMO Catalent Pharma Solutions For $16.5 Billion
2/5/2024
Catalent, Inc. (NYSE: CTLT), a leader in enabling the development and supply of better treatments for patients worldwide, and Novo Holdings, a holding and investment company that is responsible for managing the assets and wealth of the Novo Nordisk Foundation, today announced that they have entered into a merger agreement under which Novo Holdings will acquire Catalent in an all-cash transaction that values Catalent at $16.5 billion on an enterprise value basis.
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Aseptic Excellence: Microbiological Validation Seminar Announced For March 14th In Austria
2/2/2024
Aseptic manufacturing for pharmaceutical and biopharmaceutical products is being regulated and standardized as this practice continues to grow in the industry. With the publication of EU Annex 1 in Europe, there are strict guidelines to assure compliance of the aseptic process.
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Cleanroom Leader AES Clean Technology Announces New Vice President Of Construction
2/1/2024
A leading provider of high-performance cleanroom facilities, AES Clean Technology, has announced the appointment of John Costalas to its senior leadership team as Vice President of Construction.
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VersaMix Multi-Shaft Mixer Ideal For Viscous Formulations
1/31/2024
Capable of processing viscous solutions, dispersions, suspensions, and emulsions with viscosities in the hundreds of thousands of centipoise, the ROSS line of VersaMix Multi-Shaft Mixers is built for longevity, speed and efficiency. The ROSS VMC-100, pictured below, is designed for vacuum operation up to 29.5”Hg and supplied with interchangeable 100-gal mix cans, each fabricated with a 50-psig ASME-code stamped jacket for heating/cooling via glycol. The custom electro-hydraulic system is engineered to fully raise the motor drive in 15 seconds.
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AustinPx Partners With Microsize On KinetiSol® Technology
1/31/2024
AustinPx, a contract development and manufacturing organization (CDMO) specializing in bioavailability enhancement of orally delivered small molecule drug candidates, and Microsize, a leading active pharmaceutical ingredient enhancement CDMO, today announced the strategic partnership to accelerate the commercial application of AustinPx’s KinetiSol® Technology platform. The collaboration will enable AustinPx’s clients to manufacture their late-phase clinical and commercial KinetiSol drug product intermediate at Microsize’s purpose built, FDA-inspected facility.
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Kite Receives U.S. FDA Approval of Manufacturing Process Change Resulting in Reduced Median Turnaround Time for Yescarta® CAR T-cell Therapy
1/30/2024
Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has approved a manufacturing process change resulting in a shorter manufacturing time for Yescarta® (axicabtagene ciloleucel). With this approval, Kite’s median turnaround time (TAT) in the U.S. is anticipated to be reduced from 16 days to 14 days. Median TAT is defined as time from leukapheresis, when a patient’s T cells are collected, to product release; manufacturing is
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AbbVie Announces $223 Million Investment For New Biologics Manufacturing Facility In Singapore
1/29/2024
AbbVie (NYSE: ABBV) strengthened its manufacturing capabilities by breaking ground Thursday on a new US$223 million (S$301 million) expansion of its Singapore manufacturing facility. This new investment will add more than 100 jobs and new biologics manufacturing capacity to AbbVie's global network.