CGMP

Kindeva Drug Delivery Launches New Analytical Services Global Business Unit

Retrieved on: 
Wednesday, January 31, 2024

Kindeva Drug Delivery (Kindeva), a global leader in drug-device combination products, announced the expansion of its analytical services capabilities — launching a new global business unit offering integrated and stand-alone analytical support to the wider pharmaceutical, biopharmaceutical, and medical device sector.

Key Points: 
  • Kindeva Drug Delivery (Kindeva), a global leader in drug-device combination products, announced the expansion of its analytical services capabilities — launching a new global business unit offering integrated and stand-alone analytical support to the wider pharmaceutical, biopharmaceutical, and medical device sector.
  • For more than half a century, Kindeva has developed significant knowledge, experience, and expertise working on inhaled, injectable, and transdermal drug delivery development programs and cGMP commercial supply.
  • Additionally, Kindeva has built deep expertise and capability in cGMP analytical services supporting its product development and supply partners.
  • In addition to increasing Kindeva’s global analytical footprint, Kindeva’s recently opened 32,000-square-foot state-of-the-art laboratories in Woodbury, Minnesota, will serve as the central hub for its expanded suite of stand-alone analytical services.

AustinPx Partners with Microsize on KinetiSol® Technology

Retrieved on: 
Wednesday, January 31, 2024

KinetiSol is an innovative technology that utilizes frictional and shear energies to generate amorphous solid dispersions (ASD) in seconds, without the use of solvents.

Key Points: 
  • KinetiSol is an innovative technology that utilizes frictional and shear energies to generate amorphous solid dispersions (ASD) in seconds, without the use of solvents.
  • “AustinPx is excited to partner with Microsize, a like-minded client centric CDMO, on the commercial enablement of our KinetiSol Technology,” said Elizabeth Hickman, chief business officer of AustinPx.
  • The KinetiSol Technology is projected to be available at Microsize for GMP production by the end of 2024.
  • “Microsize is pleased to onboard such a powerful technology that has been shown to outperform alternative ASD technologies,” said TJ Higley, chief executive officer of Microsize.

Vivodyne Appoints Elliot Menschik, M.D., Ph.D., as Chief Technology Officer

Retrieved on: 
Wednesday, January 31, 2024

Vivodyne , a biotech that accelerates the successful discovery, design, and development of human therapeutics, today announced the appointment of Elliot Menschik, M.D., Ph.D., to the company’s Board of Directors and to the executive role of Chief Technology Officer (CTO).

Key Points: 
  • Vivodyne , a biotech that accelerates the successful discovery, design, and development of human therapeutics, today announced the appointment of Elliot Menschik, M.D., Ph.D., to the company’s Board of Directors and to the executive role of Chief Technology Officer (CTO).
  • Dr. Menschik brings more than 25 years of industry experience as a serial entrepreneur, startup investor, executive, Board director and educator.
  • View the full release here: https://www.businesswire.com/news/home/20240130194401/en/
    Prior to joining Vivodyne, Dr. Menschik was part of the founding leadership team at Resilience, a biomanufacturing partner to therapeutics companies where he was Chief Digital Officer.
  • "We’re very excited to have Elliot join Vivodyne as our CTO.

Tobin Scientific Achieves Key Quality Milestone: ISO 9001 Certification

Retrieved on: 
Tuesday, January 30, 2024

BILLERICA, Mass, Jan. 30, 2024 /PRNewswire/ -- Tobin Scientific proudly announces the attainment of ISO 9001 certification, a significant step in its ongoing commitment to quality and operational excellence.

Key Points: 
  • BILLERICA, Mass, Jan. 30, 2024 /PRNewswire/ -- Tobin Scientific proudly announces the attainment of ISO 9001 certification, a significant step in its ongoing commitment to quality and operational excellence.
  • This achievement reflects the stringent quality standards consistently upheld across Tobin Scientific's expanding cGMP facilities.
  • As the first certification of its kind within their network, it establishes a benchmark for the level of quality and excellence that Tobin Scientific is committed to in its comprehensive cGMP operations.
  • The attainment of the ISO 9001 certification from the British Standards Institution stands as a testament to Tobin Scientific's robust quality management systems and its proficiency in seamlessly incorporating complex regulatory requirements into its operational processes.

NightHawk’s Scorpius BioManufacturing Subsidiary Awarded Multimillion- Dollar Contract with a Publicly Traded Biotech Company to Support its Phase 2 Clinical Program

Retrieved on: 
Thursday, January 25, 2024

Scorpius has multiple clients with Orphan Drug Designations from the FDA, and our San Antonio facility is especially well-suited to advance these important programs.

Key Points: 
  • Scorpius has multiple clients with Orphan Drug Designations from the FDA, and our San Antonio facility is especially well-suited to advance these important programs.
  • This new client, needing biologic manufacturing for a Phase 2 clinical program under cGMP guidelines, will benefit from Scorpius' comprehensive services in process development, bioanalysis, and manufacturing.
  • The client, transitioning from a large CDMO, chose Scorpius to assist in this Phase 2 program based on our adaptability, dedicated service, and commitment to meeting project timelines.
  • With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing.

CellVax Therapeutics Announces FDA Clearance of IND Application for FK-PC101, a Novel Personalized Cancer Immunotherapy

Retrieved on: 
Monday, January 29, 2024

FK-PC101 is CellVax's novel personalized cancer immunotherapy intended to treat prostate cancer patients who have a high risk of recurrence after prostatectomy.

Key Points: 
  • FK-PC101 is CellVax's novel personalized cancer immunotherapy intended to treat prostate cancer patients who have a high risk of recurrence after prostatectomy.
  • It consists of patient's own tumor cells which are collected during surgery, then modified in the laboratory.
  • Fernando Kreutz, CEO at CellVax, stated, "We are thrilled to receive FDA clearance of our FK-PC101 IND.
  • The trial, CELLVX-230, is a randomized, multicenter, open-label study of irradiated autologous cellular vaccine in men with high-risk prostate cancer post-radical prostatectomy.

Thermo Fisher Scientific Unveils Industry’s First Off-the-Shelf Validated Software Solution to Automate Cell Therapy Manufacturing Workflows

Retrieved on: 
Wednesday, January 17, 2024

To optimize clinical manufacturing processes for innovators developing breakthrough cell therapies, Thermo Fisher Scientific today announced the launch of the Gibco™ Cell Therapy Systems (CTS™) Cellmation™ Software , a first-of-its-kind automation solution designed to connect and integrate workflows across multiple Thermo Fisher Scientific cell therapy instruments while enabling cGMP compliance.

Key Points: 
  • To optimize clinical manufacturing processes for innovators developing breakthrough cell therapies, Thermo Fisher Scientific today announced the launch of the Gibco™ Cell Therapy Systems (CTS™) Cellmation™ Software , a first-of-its-kind automation solution designed to connect and integrate workflows across multiple Thermo Fisher Scientific cell therapy instruments while enabling cGMP compliance.
  • View the full release here: https://www.businesswire.com/news/home/20240117931916/en/
    Gibco Cell Therapy Systems (CTS) Cellmation Software digitally connects instruments from across Thermo Fisher’s cell therapy portfolio to streamline and automate manufacturing.
  • By establishing an automated workflow across multiple stages of cell therapy manufacturing, CTS Cellmation Software helps enable traceability, repeatability and 21 CFR Part 11 compliance with secured data connectivity.
  • At present, CTS Cellmation Software connects core Thermo Fisher Scientific cell therapy instruments, including solutions from our Gibco CTS portfolio.

Kindeva Drug Delivery Acquires Summit Biosciences, a Specialized Nasal Drug Development and Manufacturing Organization

Retrieved on: 
Thursday, January 18, 2024

Kindeva Drug Delivery (“Kindeva”), a global leader in drug-device combination products, announced today that it has acquired Summit Biosciences Inc. (“Summit”), an intranasal drug-delivery contract development and manufacturing organization (CDMO), from its founding family shareholders.

Key Points: 
  • Kindeva Drug Delivery (“Kindeva”), a global leader in drug-device combination products, announced today that it has acquired Summit Biosciences Inc. (“Summit”), an intranasal drug-delivery contract development and manufacturing organization (CDMO), from its founding family shareholders.
  • Established in 2009, Summit has an extensive track record of innovation in the unit dose nasal spray market.
  • “Nasal drug delivery is becoming a preferred dosage format for a growing number of indications, as it allows users to non-invasively administer medications in an acute or emergency setting,” said Kindeva CEO Milton Boyer .
  • “Summit brings a differentiated understanding of how to effectively formulate drugs for nasal delivery and the capability to manufacture them at commercial scale.

Alcami Opens New Advanced Pharma Storage and Services Facility in Central North Carolina

Retrieved on: 
Wednesday, January 24, 2024

DURHAM, N.C., Jan. 24, 2024 /PRNewswire/ -- Alcami Corporation ("Alcami"), a leading contract development and manufacturing organization (CDMO), today announced the opening of its new 65,000 ft² state-of-the-art Pharma Storage and Services operations facility in Garner, North Carolina close to the Research Triangle Park biotech and pharma hub.

Key Points: 
  • - Ambient storage now open for shipments, with stability storage, aliquoting and cold storage phasing in later in 2024
    DURHAM, N.C., Jan. 24, 2024 /PRNewswire/ -- Alcami Corporation ("Alcami"), a leading contract development and manufacturing organization (CDMO), today announced the opening of its new 65,000 ft² state-of-the-art Pharma Storage and Services operations facility in Garner, North Carolina close to the Research Triangle Park biotech and pharma hub.
  • The new central North Carolina facility, now accepting client pallets for ambient/controlled room temperature storage, adds to the company's network of GMP storage facilities across North America.
  • Part of the company's intentional strategy to strengthen its pharma storage and services business with key locations to streamline operations for biotech and pharma clients, the site will phase in stability storage and aliquoting, followed by cold storage later this year.
  • "As pressures intensify to outsource GMP storage of biopharmaceutical materials and products for cost savings that can fuel clients' R&D and other projects, our new RTP pharma storage and services facility is well-positioned to fill this previously unmet market demand," said Laurent Boer, President, Alcami Pharma Storage and Services.

HDT Bio Receives $749,000 EZBAA Contract and Partners with BARDA Under Project NextGen's Enabler's Program

Retrieved on: 
Tuesday, January 23, 2024

Through this partnership, HDT Bio has received a $749,000 contract, which will support proof-of-concept studies for on-demand manufacturing and release processes that use HDT Bio's LION™ formulation for RNA vaccine production.

Key Points: 
  • Through this partnership, HDT Bio has received a $749,000 contract, which will support proof-of-concept studies for on-demand manufacturing and release processes that use HDT Bio's LION™ formulation for RNA vaccine production.
  • The Project NextGen Enabler's program aims to advance next generation vaccine and therapeutics technologies, including the development of innovative cGMP manufacturing of vaccines that decrease costs, speed production, increase efficacy, and improve access.
  • "We are honoured to collaborate with BARDA through the receipt of this award under the Project NextGen Enabler's program.
  • The funding will also support development of novel microfluidic mixing chips that enable automated, rapid-release, assay-free preparation of vaccines.