Good manufacturing practice

Breaking Ground in Prostate Cancer: BriaCell Announces Lead Prostate Cancer Candidate Bria-Pros+, Initiates GMP Manufacturing

Retrieved on: 
Tuesday, February 6, 2024
Prostate cancer, Investigational New Drug, Cytokine, Immunotherapy, SITC, Clinical trial, NK, Society, Patient, IND, Good, Death, TSX, Allele, NKT, Therapy, Vaccine, Good manufacturing practice, HLA, Cancer, GMP, BCT

We are enthusiastic about commencing GMP manufacturing for our prostate cancer clinical candidate, continuing our efforts at transforming targeted cancer therapy via the introduction of potent personalized cellular cancer vaccines,” stated Dr. William V. Williams, BriaCell’s President and CEO.

Key Points: 
  • We are enthusiastic about commencing GMP manufacturing for our prostate cancer clinical candidate, continuing our efforts at transforming targeted cancer therapy via the introduction of potent personalized cellular cancer vaccines,” stated Dr. William V. Williams, BriaCell’s President and CEO.
  • “The successful development of this first candidate showcases our capacity to create novel cancer immunotherapies and advance them towards clinical application.
  • BriaCell genetically engineers cancer cell lines to produce cytokines and co-stimulatory factors that significantly increase immune stimulation compared to the unmodified (parent) cancer cell lines.
  • According to 2024 Cancer Facts & Figures , prostate cancer is projected to be the most common cancer among men in 2024.

National Resilience and Taiwan Bio-Manufacturing Corporation Announce Groundbreaking Partnership in Biomanufacturing Innovation

Retrieved on: 
Monday, February 5, 2024
Science, Other Science, Biotechnology, Pharmaceutical, Other Manufacturing, Health, Health Technology, Manufacturing, Partnership, Economy, CGMP, Good manufacturing practice, Government, CDMO, Patient, Good, Laboratory, Dicarboxylic acid, Automation, Vaccine, Doctor of Philosophy, Engineering, Workforce, Organization, Management

National Resilience, Inc. (Resilience), a technology-focused biomanufacturing company dedicated to broadening access to complex medicines, and Taiwan Bio-Manufacturing Corporation (TBMC), proudly announce a groundbreaking joint venture which aims to transform the biomanufacturing industry.

Key Points: 
  • National Resilience, Inc. (Resilience), a technology-focused biomanufacturing company dedicated to broadening access to complex medicines, and Taiwan Bio-Manufacturing Corporation (TBMC), proudly announce a groundbreaking joint venture which aims to transform the biomanufacturing industry.
  • However, large-scale biomanufacturing processes have struggled to keep pace with the ability to produce these new, complex therapies.
  • Recognizing this gap, Resilience and TBMC will join forces to provide an effective path forward for the efficient production of next-generation treatments.
  • In return, Resilience becomes an equity shareholder of TBMC, fostering a close partnership to develop advanced manufacturing technologies for complex modalities and drive innovation in the industry.

Entos Pharmaceuticals Launches GMP Clinical Manufacturing Facility in Carlsbad, California

Retrieved on: 
Thursday, January 25, 2024
Biotechnology, Health, Genetics, Pharmaceutical, Clinical Trials, Eye, Facility, Plasmid, PLV, DNA, Multimedia, GMP, Good manufacturing practice, Infection, IND, Medication, COVID-19, Myenteric plexus, Messenger, Vaccine

Entos Pharmaceuticals (Entos), a clinical-stage biotechnology company developing genetic medicines with its proprietary Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, today announced the launch of its new Good Manufacturing Practices (GMP) manufacturing facility in Carlsbad, California.

Key Points: 
  • Entos Pharmaceuticals (Entos), a clinical-stage biotechnology company developing genetic medicines with its proprietary Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, today announced the launch of its new Good Manufacturing Practices (GMP) manufacturing facility in Carlsbad, California.
  • View the full release here: https://www.businesswire.com/news/home/20240125096146/en/
    Entos Pharmaceuticals GMP Manufacturing Facility; Photo credit: Sean Hawkins, Facility Manager
    The state-of-the-art facility features 20,000 square feet of dedicated manufacturing space, including a lipid formulation production suite with additional suites dedicated to mRNA and plasmid DNA manufacturing.
  • “The successful commissioning of the site, followed by GMP batch manufacturing, exemplifies the potential of our facility.
  • The launch of this new Entos facility is a key step in the company’s global manufacturing strategy as it looks to establish a future manufacturing site in Edmonton, Alberta, Canada, to enable the commercial manufacturing of emerging transformative medicines for Entos and its valued partners.

Thermo Fisher Scientific Receives GMP approval from the Italian Medicines Agency (AIFA) for its Manufacturing facility of RNA-Based Products in Monza, Italy

Retrieved on: 
Friday, January 19, 2024
Biotechnology, Manufacturing, Other Health, Health, Pharmaceutical, Oncology, Research, Other Manufacturing, Infectious Diseases, Science, Clinical Trials, Patient, Syringe, RNA, Thermo Fisher Scientific, Good manufacturing practice, Cancer, Monza, GMP, Therapy, Vaccine, LNP

Thermo Fisher Scientific, the world leader in serving science, has received Good Manufacturing Practice (GMP) approval from the Italian Medicines Agency (AIFA) allowing the company to manufacture RNA-based products at its Monza, Italy site.

Key Points: 
  • Thermo Fisher Scientific, the world leader in serving science, has received Good Manufacturing Practice (GMP) approval from the Italian Medicines Agency (AIFA) allowing the company to manufacture RNA-based products at its Monza, Italy site.
  • The approval and associated certification support increased accessibility to novel therapies for patients with difficult to treat conditions, marking a significant achievement within the Thermo Fisher Scientific network and for Italy as a whole.
  • “RNA technology is being explored for a variety of modalities, including rare diseases and cancer which have limited treatment options,” said Dan Herring, General Manager, Advanced Therapies, Pharma Services at Thermo Fisher Scientific.
  • With more than 30 years of experience manufacturing sterile injectables, biologics, and advanced therapies, Thermo Fisher has the capabilities and expertise required to help customers accelerate development and increase access to therapies for patients globally.

Labelmaster Announces Distribution Partnership with CurTec

Retrieved on: 
Wednesday, January 17, 2024
Other Transport, Food, Beverage, Trucking, Manufacturing, Rail, Maritime, Retail, Air, Transport, Pharmaceutical, Software, Supply Chain Management, Logistics, Technology, Agriculture, Natural Resources, Health, Packaging, Chemicals, Plastics, Powder, Waste management, UV, Food and Drug Administration, HDPE, UN, Good manufacturing practice, GMP, Safety, FDA, Dust, Certification

Labelmaster , the leading provider of products, services and technology for the safe and compliant transport of dangerous goods (DG) and hazardous materials (hazmat), today announced it has expanded its packaging business by offering a robust assortment of CurTec high-performance plastic containers, drums and pails .

Key Points: 
  • Labelmaster , the leading provider of products, services and technology for the safe and compliant transport of dangerous goods (DG) and hazardous materials (hazmat), today announced it has expanded its packaging business by offering a robust assortment of CurTec high-performance plastic containers, drums and pails .
  • As a premier North American distributor for CurTec, Labelmaster now offers the broadest assortment of UN-certified containers, which are designed to securely fill, store, and transport a wide variety of hazmat solids and powders.
  • Click here to see the CurTec packaging solutions available from Labelmaster.
  • “Labelmaster is committed to addressing the increasingly complex supply chain needs of dangerous goods shippers by providing a wide range of innovative packaging,” said John Glaser, director, packaging development, Labelmaster.

CORBEVAX®, A COVID19 VACCINE DEVELOPED BY BIO E-INDIA BASED ON THE RBD PROTEIN ANTIGEN TECHNOLOGY FROM TEXAS CHILDREN'S HOSPITAL CENTER FOR VACCINE DEVELOPMENT, RECEIVES WORLD HEALTH ORGANIZATION EMERGENCY USE LISTING APPROVAL

Retrieved on: 
Monday, January 22, 2024
COVAXIN, World Health Organization, Texas Children's Hospital, UNICEF, COVID19, Tropical medicine, Dean (education), EUL, Medicine, DRS, CVD, BCM, National academy, Baylor College of Medicine, UN, RBD, Baylor University, GMP, Good, CDSCO, Dean, WHO, Safety, COVID-19, Hospital, Biomedical Research, Good manufacturing practice, Nobel Peace Prize, Alum, Vaccine, DCGI, SARS-CoV-2, National school, Biology

HOUSTON, Jan. 22, 2024 /PRNewswire/ -- Texas Children's Hospital announces today that Biological E's CORBEVAX®, a traditional, recombinant protein-based COVID-19 vaccine has received World Health Organization (WHO) approval under Emergency Use Listing (EUL). CORBEVAX® is developed and commercialized by Biological E Limited, an established global vaccine supplier based in Hyderabad, India, using Pichia pastoris yeast strain expressing Receptor Binding Domain (RBD) protein of SARS-CoV-2 engineered by Texas Children's Hospital Center for Vaccine Development (CVD) and Baylor College of Medicine (BCM),

Key Points: 
  • "The recombinant yeast strains enable production of the RBD protein which can be further utilized by vaccine researchers globally to develop & manufacture effective and low-cost vaccines.
  • By providing access to the yeast strains via non-exclusive licensing, we continue our mission to support global vaccine accessibility and availability."
  • Biological E subsequently developed large scale manufacturing technology for production of the RBD protein complying with Good Manufacturing Practices (GMP) as well as testing & characterization suitable for use as vaccine antigen.
  • The RBD protein was then used as an antigen and formulated with optimized adjuvants (Alum and CpG1018) to develop a COVID-19 candidate vaccine.

CGI and Körber announce global partnership to enable pharmaceutical and life sciences clients to improve production operations

Retrieved on: 
Monday, January 22, 2024
Lykke, Senior, Research, GIB, Health, Partnership, Cancer, Good manufacturing practice, TSX, Safety, MES, Software, CGI, Organization, Fine chemical

The global partnership is designed to help clients increase efficiency, accuracy, and safety in pharma products and enhance decision-making through access to real-time data.

Key Points: 
  • The global partnership is designed to help clients increase efficiency, accuracy, and safety in pharma products and enhance decision-making through access to real-time data.
  • "CGI works side-by-side with clients to transform data into actionable insights to drive smart, sustainable and resilient operations," said Tim Hurlebaus President, U.S. Commercial & State Government operations and global executive sponsor for CGI's health and life sciences business.
  • Our partnership with Körber complements our offerings portfolio, enabling us to deliver innovative new services and solutions to support the needs of our pharma and life sciences clients."
  • "In our global client insights research , pharma and life sciences executives said optimizing operations is their top business priority.

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

Retrieved on: 
Tuesday, January 16, 2024
Global Rights, Partnership, CGMP, Exosome, Good manufacturing practice, Sale, Quality, CMO, Doctor of Philosophy

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.

ITM Appoints Dr. Mark Harfensteller as Member of its Executive Board

Retrieved on: 
Tuesday, January 16, 2024
Engineering, Patient, Head, Industrial organization, Institute of technology, CFO, Knowledge, CBO, Science, NOVA, Good manufacturing practice, Cancer, GMP, Good, Mechanical, Quality of life, Supervisory board, ITM, CNL, Actinium-225, Therapy, Doctor of Philosophy, Research and development, Research, Pleasure, Societas Europaea, Radionuclide, ITM Group of Institutions, Mechanical engineering, Growth, Management

Garching / Munich, Germany, January 16, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the appointment of Dr. Mark Harfensteller to its Executive Board.

Key Points: 
  • Garching / Munich, Germany, January 16, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the appointment of Dr. Mark Harfensteller to its Executive Board.
  • Since 2016, he has held the position of Chief Operating Officer (COO) and Managing Director of ITM Medical Isotopes GmbH, a subsidiary of ITM SE.
  • As a Societas Europaea (“SE”) entity, ITM SE is governed by a two-tier board structure consisting of an Executive Board and a Supervisory Board, in which the latter oversees the Executive Board.
  • Under this framework, the Executive Board is comprised of members of the management team, while the Supervisory Board is generally controlled by shareholders.

Ziel Microbial Control Solution for Cannabis Receives EU GMP Certification

Retrieved on: 
Tuesday, January 9, 2024
Entrepreneurship, RF, European, European Medicines Agency, Radio frequency, Radiation, SAN, Radio, RFX, Good manufacturing practice, GMP, EMA, Ammunition Design Group, Conference, Apple, Cannabis, Certification

SAN FRANCISCO, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Ziel’s Radio Frequency (RF) technology received Good Manufacturing Practice (GMP) certification in the European market for the control of microbial pathogens in cannabis flower.

Key Points: 
  • SAN FRANCISCO, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Ziel’s Radio Frequency (RF) technology received Good Manufacturing Practice (GMP) certification in the European market for the control of microbial pathogens in cannabis flower.
  • “We are delighted that our radio frequency technology has received the first EU GMP approval for microbial control,” says Arthur de Cordova, CEO and Co-Founder of Ziel.
  • With this first GMP certification, Ziel’s technology now provides cultivators and post-harvest processors seeking to produce within the EU, or export to the EU, a clear, streamlined pathway for integrating a microbial control step into their operations.
  • Ziel introduced its next generation cannabis microbial control solution, the RFX, in November 2023 at the MJBiz Conference in Las Vegas.