CGMP

InstantGMP Inc. Welcomes Insane Labz to Enhanced Manufacturing Excellence

Retrieved on: 
Tuesday, January 23, 2024

CARY, N.C., Jan. 23, 2024 /PRNewswire-PRWeb/ -- InstantGMP™, the leader in software systems that captures your manufacturing, inventory and quality data, is excited to announce its newest client, Insane Labz®, a renowned nutritional supplement company.

Key Points: 
  • Derek Mathis, Quality Manager of Insane Labz, shared, "InstantGMP PRO has revolutionized our manufacturing processes.
  • Initially relying on third-party co-packers, Insane Labz established its own manufacturing facility in 2014, demonstrating a commitment to producing high quality products in an FDA registered, cGMP certified facility.
  • InstantGMP PRO provides Insane Labz with an end-to-end integrated manufacturing/inventory/quality system that enables precise control over formulation, ingredient sourcing, manufacturing, testing, and product distribution.
  • Derek Mathis, Quality Manager of Insane Labz, expressed his enthusiasm for this software solution by stating, "InstantGMP PRO has revolutionized our manufacturing processes.

Pharmaceutical Compliance Audits: Adapting to Enhanced FDA Inspection Protocols, 2 Day Online Training Seminar

Retrieved on: 
Thursday, January 18, 2024

Factor US FDA compliance inspection emphasis into the company's audit preparedness and replicate key points for internal and supplier audits.

Key Points: 
  • Factor US FDA compliance inspection emphasis into the company's audit preparedness and replicate key points for internal and supplier audits.
  • Using the field tested techniques presented in this seminar, an internal and/or supplier audit can provide much the same early warnings as a real FDA compliance cGMP audit.
  • This seminar will provide test scripts and rationale for a 'model' for company internal and supplier audits.
  • It will describe a 'typical' US FDA inspection, and points to replicate with an internal audit or supplier audit.

Alcami Announces Acquisition of West-Coast Based Pacific Pharmaceutical Services

Retrieved on: 
Wednesday, January 17, 2024

DURHAM, N.C., Jan. 17, 2024 /PRNewswire/ -- Alcami Corporation ("Alcami"), a leading contract development and manufacturing organization (CDMO), announced today it has completed the acquisition of Pacific Pharmaceutical Services, Inc. ("PPS"), a preferred provider of cGMP pharma storage and services.

Key Points: 
  • DURHAM, N.C., Jan. 17, 2024 /PRNewswire/ -- Alcami Corporation ("Alcami"), a leading contract development and manufacturing organization (CDMO), announced today it has completed the acquisition of Pacific Pharmaceutical Services, Inc. ("PPS"), a preferred provider of cGMP pharma storage and services.
  • "The Pacific Pharmaceutical Services acquisition is part of our highly intentional strategy to supercharge the capabilities of our pharma storage and services business with locations that best serve biotech and pharma clients across the country," commented Bill Humphries, CEO of Alcami.
  • Combined with the acquisition, this additional expansion underscores Alcami's focus on its comprehensive pharma storage and services business.
  • Similarly, Alcami's extensive client base will have access to PPS' West Coast cGMP pharma storage capacity and support services, ensuring a seamless experience across the Alcami network of laboratory, pharma storage and manufacturing services.

ELEVAI Labs, Inc. Acquires Worldwide License Agreement for Proprietary Stem Cell Manufacturing Technology

Retrieved on: 
Tuesday, January 16, 2024

The licensing agreement grants Elevai a license to use INmune Bio’s proprietary “EMx” technology, developed by INmune Bio, Inc., CMO, Mark Lowdell, PhD, that enables Elevai to manufacture current Good Manufacturing Practice (“cGMP”) grade, human umbilical cord-derived mesenchymal stromal cells (hucMSCs) at a lower cost to Elevai than purchasing hucMSCs outright.

Key Points: 
  • The licensing agreement grants Elevai a license to use INmune Bio’s proprietary “EMx” technology, developed by INmune Bio, Inc., CMO, Mark Lowdell, PhD, that enables Elevai to manufacture current Good Manufacturing Practice (“cGMP”) grade, human umbilical cord-derived mesenchymal stromal cells (hucMSCs) at a lower cost to Elevai than purchasing hucMSCs outright.
  • Highlights of the Licensing Agreement:
    Innovative Manufacturing: The licensed “EMx” technology is a proprietary manufacturing process that entails specific know-how designed to efficiently produce cGMP grade hucMSCs.
  • The licensing agreement grants Elevai an exclusive license, to utilize “EMx” technology for the development and commercialization of licensed topical cosmetic applications.
  • In response to the license agreement, Jordan R. Plews, PhD, CEO of Elevai Labs, Inc. stated: "partnering with INmune Bio, Inc. aligns perfectly with our mission to pioneer innovative stem cell exosome products.

KBI Biopharma, Inc. and Argonaut Manufacturing Services, Inc. Forge Strategic Alliance to Support Global Biopharmaceutical Companies with Integrated Drug Substance and Drug Product Solutions

Retrieved on: 
Tuesday, January 16, 2024

KBI Biopharma, Inc. (KBI), a JSR Life Sciences company and cGMP contract development and manufacturing organization (CDMO), and Argonaut Manufacturing Services, Inc. (Argonaut), a cGMP contract manufacturing organization (CMO) serving the biopharmaceutical and diagnostics industries, today announced a strategic alliance offering biopharmaceutical clients with end-to-end drug substance and drug product manufacturing solutions.

Key Points: 
  • KBI Biopharma, Inc. (KBI), a JSR Life Sciences company and cGMP contract development and manufacturing organization (CDMO), and Argonaut Manufacturing Services, Inc. (Argonaut), a cGMP contract manufacturing organization (CMO) serving the biopharmaceutical and diagnostics industries, today announced a strategic alliance offering biopharmaceutical clients with end-to-end drug substance and drug product manufacturing solutions.
  • The arrangement provides a seamless integration of drug substance and drug product manufacturing by combining KBI’s leading drug development and biologics manufacturing services with Argonaut’s expertise in sterile fill-finish.
  • The alliance reinforces both companies’ commitment to support customers in bringing clinical and commercial therapies to patients quickly, safely, and efficiently.
  • “At KBI Biopharma, we have always been committed to delivering innovative solutions that accelerate the development and manufacturing of life-saving therapeutics.

PharmaTher Provides Update for Expected FDA Approval of Ketamine

Retrieved on: 
Wednesday, January 10, 2024

The assigned FDA approval goal date is still on track.

Key Points: 
  • The assigned FDA approval goal date is still on track.
  • Fabio Chianelli, CEO of PharmaTher, commented: “We believe 2024 will be a transformative year for PharmaTher with the expected FDA approval of ketamine having an assigned goal date for approval on April 29, 2024.
  • On October 10, 2023, the FDA published a compounding risk alert describing the potential risks associated with compounded ketamine products for psychiatric disorders, specifically from telehealth providers that provide in-home ketamine services.
  • Following the FDA approval and launch in the U.S., the Company will pursue international approvals to support the global demand for ketamine.

Xcell Biosciences Announces Collaboration with ElevateBio to Advance Technology Development for Cell and Gene Therapies

Retrieved on: 
Thursday, January 11, 2024

Xcell Biosciences, Inc. (Xcellbio), a platform technology company focused on cell and gene therapy applications, today announced a collaboration with ElevateBio, LLC (ElevateBio), through which the companies aim to explore novel approaches to improving therapeutic potency of cell and gene therapies.

Key Points: 
  • Xcell Biosciences, Inc. (Xcellbio), a platform technology company focused on cell and gene therapy applications, today announced a collaboration with ElevateBio, LLC (ElevateBio), through which the companies aim to explore novel approaches to improving therapeutic potency of cell and gene therapies.
  • As part of this collaboration, ElevateBio becomes the first member of Xcellbio’s beta program for its new AVATAR Foundry™ device.
  • In addition, Michael Paglia, Chief Technology Officer at ElevateBio’s BaseCamp®, has joined Xcellbio’s Scientific Advisory Board.
  • ElevateBio is a technology-driven company commercializing its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate the development of genetic medicines.

2024 Annual cGMP (Current Good Manufacturing Practices) Online Master Class

Retrieved on: 
Friday, January 12, 2024

DUBLIN, Jan. 12, 2024 /PRNewswire/ -- The "Annual GMP Master Class 2024" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Jan. 12, 2024 /PRNewswire/ -- The "Annual GMP Master Class 2024" training has been added to ResearchAndMarkets.com's offering.
  • cGMPs or Current Good Manufacturing Practices is a general encompassing term for the regulations that the control of all facets of life sciences manufacturing processes and facilities particularly pharmaceutical products.
  • This formal system of controls if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors.
  • Accordingly, the 'c' in cGMP stands for 'current,' requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations.

DEADLINE ALERT for SCYX, LICY, and FMC: The Law Offices of Frank R. Cruz Reminds Investors of Class Actions on Behalf of Shareholders

Retrieved on: 
Monday, January 8, 2024

LOS ANGELES, Jan. 08, 2024 (GLOBE NEWSWIRE) -- The Law Offices of Frank R. Cruz reminds investors that class action lawsuits have been filed on behalf of shareholders of the following publicly-traded companies.

Key Points: 
  • LOS ANGELES, Jan. 08, 2024 (GLOBE NEWSWIRE) -- The Law Offices of Frank R. Cruz reminds investors that class action lawsuits have been filed on behalf of shareholders of the following publicly-traded companies.
  • Investors have until the deadlines listed below to file a lead plaintiff motion.
  • Investors suffering losses on their investments are encouraged to contact The Law Offices of Frank R. Cruz to discuss their legal rights in these class actions at 310-914-5007 or by email to [email protected] .
  • The Law Offices of Frank R. Cruz, Los Angeles

ElevateBio to Highlight Growth of its Genetic Medicine Business Driven By Gene Editing and Manufacturing Partnerships at the 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 8, 2024

Chairman and Chief Executive Officer, David Hallal, will provide a business update at the 42nd Annual J.P. Morgan Healthcare Conference on January 8, 2024 at 9:30 am PT.

Key Points: 
  • Chairman and Chief Executive Officer, David Hallal, will provide a business update at the 42nd Annual J.P. Morgan Healthcare Conference on January 8, 2024 at 9:30 am PT.
  • Announced two transformative R&D collaborations with Moderna and Novo Nordisk to discover and develop gene editing therapeutics.
  • BaseCamp is ElevateBio’s genetic medicine process development and cGMP business enabling biopharmaceutical partners with its end-to-end capabilities.
  • Developed additional C-base editors for gene knock-outs in novel cell therapies and A-base editors for in vivo gene editing therapeutics.