Latest Headlines
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AES Clean Technology Sets New Standards For Cleanliness And Efficiency In cleanrooms with The Launch Of Its CleanLock Module
4/16/2024
AES Clean Technology, a leading provider of high-performance cleanroom facilities, has launched its CleanLock Module™ today. This revolutionary airlock solution enhances cleanliness, speed, and efficiency in cleanroom project execution.
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Imugene And Kincell Bio Announce Strategic Manufacturing And Process Development Partnership
4/16/2024
Imugene, Ltd. (“Imugene”)(ASX: IMU) and Kincell Bio, LLC (“Kincell”), announce a strategic manufacturing and process development partnership, which includes the sale of Imugene’s North Carolina Current Good Manufacturing Practice (CGMP) manufacturing facility and the transfer of process and analytical development activities to Kincell.
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Ascend Acquires GMP Manufacturing Capacity In Alachua, Florida; Enters Long-Term Partnership With Beacon Therapeutics For Clinical And Commercial AAV Production
4/9/2024
Ascend Advanced Therapies (Ascend), a total solutions gene therapy development partner, has acquired the CMC team and site in Alachua, Florida from Beacon Therapeutics (Beacon). The transaction brings an operational good manufacturing practice (GMP) facility, process and analytical development capabilities, and additional experts to the Ascend team. It also includes a long-term partnership with Beacon to continue manufacturing its products for clinical and commercial use, securing product supply for Beacon and enabling it to focus on clinical development.
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CDMO Kindeva Drug Delivery Installs First Syntegon Versynta microBatch Filling System In North America
4/9/2024
Syntegon today announced the sale of its newly developed Versynta microBatch production cell to its first U.S. customer. Kindeva Drug Delivery will use Versynta microBatch to further expand its suite of aseptic fill-finish contract development and manufacturing (CDMO) capabilities meeting the latest global pharmaceutical regulations and trends. Kindeva is a leading global CDMO that develops and manufactures products across a range of routes of administration including injectable, pulmonary, nasal, transdermal, and intradermal delivery.
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John Witkowski Appointed President & CEO Of Solesis
4/9/2024
Solesis, a leader in the custom design, development, and manufacturing of textile- and polymer-based healthcare solutions for the medical device and biopharmaceutical industries, is pleased to announce that John Witkowski has been appointed as the new President & CEO, effective immediately. In this role, Witkowski is responsible for developing the strategic priorities for Solesis and executing world-class business operations to support customers and drive long-term, sustainable growth.
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Honeywell Announces Upcoming Webinar and Conference Schedule
3/19/2024
Visit us at Booth 17 to learn more about our unified manufacturing operations platform and how it accelerates innovation and increases efficiency, quality, and compliance.
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Manufacturing Gene Therapy For Early-Onset Metachromatic Leukodystrophy
3/19/2024
AGC Biologics received U.S. Food and Drug Administration (FDA) clearance at the company’s Milan site to begin commercial manufacturing for the lentiviral vector and genetically modified cell drug product (DP) of Orchard Therapeutics’ Lenmeldy™ (atidarsagene autotemcel), a hematopoietic stem cell (HSC) gene therapy for the treatment of pre-symptomatic late infantile, pre-symptomatic early juvenile and early symptomatic early juvenile metachromatic leukodystrophy (MLD).
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Pluri Selected As CDMO By Remedy Cell For Cell-Derived Cell-Free Drug Manufacturing
3/14/2024
Pluri Inc. (Nasdaq:PLUR) (TASE:PLUR) ("Pluri" or "the Company"), a leading biotechnology company that transforms cells into solutions, today announced that its CDMO division (PluriCDMO™) has signed a manufacturing agreement with Remedy Cell Ltd, an innovative, biopharmaceutical company developing stem cell-derived, cell-free therapeutics for complex fibrotic conditions.
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AES Clean Technology Appoints New Vice President Of Engineering
2/22/2024
AES Clean Technology, a leading provider of high-performance modular cleanroom facilities, has appointed Chris Barbieri as Vice President of Engineering.
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WuXi Advanced Therapies Receives FDA Approval To Manufacture Iovance’s AMTAGVI™ (lifileucel) For Advanced Melanoma
2/20/2024
WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, today announced that the U.S. Food and Drug Administration (FDA) has approved its Philadelphia site to begin the analytical testing and manufacturing of AMTAGVI for Iovance, which received FDA accelerated approval of its Biologics License Application (BLA) on February 16, 2024.