Good manufacturing practice

GenSight Biologics Reports Cash Position as of March 31, 2024, and Provides Business Update

Retrieved on: 
Thursday, April 4, 2024
Health, Neurology, Genetics, Pharmaceutical, Optical, Biotechnology, PIII, URD, Three-body problem, Patient, Good manufacturing practice, Health care, EAP, Acquisition, EMA, Risk, Chapter, GMP, MHRA, DS, ATU, AMF, Good, Phase, AAP, Ethics, FDA, Amendment, AAC, Medication, Pharmaceutical industry

GenSight Biologics ("GenSight Biologics" or the "Company") (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported its cash position as of March 31, 2024 and provided a business update.

Key Points: 
  • GenSight Biologics ("GenSight Biologics" or the "Company") (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported its cash position as of March 31, 2024 and provided a business update.
  • Once the AAC/AAP program resumes, the Company estimates that the cash runway would be extended to the end of Q1 2025.
  • GenSight successfully manufactured two Drug Substance (DS) batches of LUMEVOQ® meeting Good Manufacturing Practice (GMP) standards in September and November 2023.
  • As of March 31, 2024, GenSight Biologics’ number of outstanding shares was 78,370,724 ordinary shares.

Charles River to Perform Plasmid Production for Ship of Theseus

Retrieved on: 
Thursday, April 4, 2024
Research, Medical Devices, Genetics, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Diabetes, Neutropenia, CDMO, Psoriasis, Infertility, Cancer, MCB, Tissue, CRL, DNA, Pattern hair loss, HOX, Ship, Acquisition, Factorization of polynomials, Display resolution, GMP, Good manufacturing practice, Tecmar, Therapy, HQ, Vaccine

Charles River Laboratories International, Inc. (NYSE: CRL) and Ship of Theseus , a therapeutics company developing degradation-resistant homeobox (HOX) family biologics, today announced a Good Manufacturing Practice- (GMP) plasmid DNA contract development and manufacturing organization (CDMO) agreement.

Key Points: 
  • Charles River Laboratories International, Inc. (NYSE: CRL) and Ship of Theseus , a therapeutics company developing degradation-resistant homeobox (HOX) family biologics, today announced a Good Manufacturing Practice- (GMP) plasmid DNA contract development and manufacturing organization (CDMO) agreement.
  • Ship of Theseus will leverage Charles River’s premier expertise to manufacture GMP plasmid DNA to serve as the active drug substance for its lead candidate.
  • Charles River’s GMP plasmid DNA CDMO center of excellence based in Keele, United Kingdom will lead the collaboration, providing services that include plasmid DNA backbone generation, plasmid synthesis, GMP master cell bank (MCB) generation, pre-production evaluation, and GMP plasmid DNA manufacture including in-house release testing.
  • We trust the team’s decades of success developing, producing, and reliably delivering plasmid DNA and look forward to bringing our therapies to patients.” – Jeremy Elser, Founding CEO, Ship of Theseus

Charles River to Perform Plasmid Production for Ship of Theseus

Retrieved on: 
Thursday, April 4, 2024
Health, Medical Devices, Stem Cells, Genetics, General Health, Pharmaceutical, Biotechnology, Diabetes, Neutropenia, CDMO, Psoriasis, Infertility, Cancer, MCB, Tissue, CRL, DNA, Research, Pattern hair loss, HOX, Ship, Acquisition, Factorization of polynomials, Display resolution, GMP, Good manufacturing practice, Tecmar, Therapy, HQ, Vaccine

Charles River Laboratories International, Inc. (NYSE: CRL) and Ship of Theseus , a therapeutics company developing degradation-resistant homeobox (HOX) family biologics, today announced a Good Manufacturing Practice- (GMP) plasmid DNA contract development and manufacturing organization (CDMO) agreement.

Key Points: 
  • Charles River Laboratories International, Inc. (NYSE: CRL) and Ship of Theseus , a therapeutics company developing degradation-resistant homeobox (HOX) family biologics, today announced a Good Manufacturing Practice- (GMP) plasmid DNA contract development and manufacturing organization (CDMO) agreement.
  • Ship of Theseus will leverage Charles River’s premier expertise to manufacture GMP plasmid DNA to serve as the active drug substance for its lead candidate.
  • Charles River’s GMP plasmid DNA CDMO center of excellence based in Keele, United Kingdom will lead the collaboration, providing services that include plasmid DNA backbone generation, plasmid synthesis, GMP master cell bank (MCB) generation, pre-production evaluation, and GMP plasmid DNA manufacture including in-house release testing.
  • We trust the team’s decades of success developing, producing, and reliably delivering plasmid DNA and look forward to bringing our therapies to patients.” – Jeremy Elser, Founding CEO, Ship of Theseus

Teva and mAbxience Announce Strategic Global Licensing Agreement for Oncology Biosimilar Candidate

Retrieved on: 
Thursday, April 4, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, TEVA, Partnership, Business, Patient, CGMP, Good manufacturing practice, Business development, Doctor of Philosophy, Biosimilar, Fresenius (company), Teva, Generic drug

Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced they have entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications.

Key Points: 
  • Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced they have entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications.
  • Biosimilars show promising potential in providing more cost-effective alternatives to existing oncology therapies, thereby addressing a critical need in global oncology care.
  • The licensing agreement covers multiple global markets, including in Europe and the United States, signaling a major step in mAbxience’s global expansion strategy, and supports a key element of Teva’s Pivot to Growth strategy, announced in 2023, to expand its biosimilar pipeline through business development and strategic partnerships.
  • Under the terms of the licensing agreement, mAbxience will leverage its expertise in biosimilar development and its state-of-the-art, current Good Manufacturing Practice (cGMP)-approved facilities in Spain and Argentina, to develop and produce the biosimilar product.

NSF Marks Milestones in Personal Care for Athletes

Retrieved on: 
Thursday, March 21, 2024
General Sports, Sports, Natural Resources, Other Retail, Specialty, Cosmetics, Cannabis, Retail, CFL, Solvent, Health, Certification, Organization, Sport, Therapy, Dietary supplement, Risk, Senior ice hockey, National Hockey League, Public, Good manufacturing practice, LPGA, Ironman, Selective androgen receptor modulator, AFL, Growth hormone, CBD, Massage, Athlete, NHL, GMP, NSF, MLB, CCES, Diuretic, Former, USADA, Good, Sports medicine, NBA, PGA, THC, UFC, Steroid, NFL, NASCAR, Major League Baseball, Nursing

These certifications mark two major milestones: CBDHCC is NSF’s first client in the world to comply with NSF Guideline 527, which demonstrates the product formula meets strict limits and is free of unsafe levels of impurities and adulterants; it is also the first personal care product to earn NSF Certified for Sport® certification.

Key Points: 
  • These certifications mark two major milestones: CBDHCC is NSF’s first client in the world to comply with NSF Guideline 527, which demonstrates the product formula meets strict limits and is free of unsafe levels of impurities and adulterants; it is also the first personal care product to earn NSF Certified for Sport® certification.
  • "The spirit of clean athletic competition is something we all connect with,” said David Trosin, Senior Director, Global Certification at NSF.
  • NSF Certified for Sport® certifies dietary supplements, functional foods, cosmetics and personal care products to be free from substances banned by major sporting organizations.
  • Products Certified for Sport® must also be certified to either NSF/ANSI 173, NSF 229 or NSF 527 to ensure their contents match their claims.

Charles River and Navega Therapeutics Announce Comprehensive Gene Therapy Manufacturing Collaboration

Retrieved on: 
Thursday, March 14, 2024
Research, Medical Devices, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Erythromelalgia, AAV, Diabetic neuropathy, CDMO, Patient, CRL, Good manufacturing practice, Gene, DNA, CAP, Chronic pain, Doctor of Philosophy, GMP, Navega, Therapy, Peripheral neuropathy, CGT, Pharmaceutical industry

Charles River Laboratories International, Inc. (NYSE: CRL) and Navega Therapeutics , Inc., a biotechnology company developing epigenetic gene therapies, today announced an AAV9 production program agreement.

Key Points: 
  • Charles River Laboratories International, Inc. (NYSE: CRL) and Navega Therapeutics , Inc., a biotechnology company developing epigenetic gene therapies, today announced an AAV9 production program agreement.
  • As part of Charles River’s Cell and Gene Therapy (CGT) Accelerator Program (CAP), Navega will have access to established contract development and manufacturing (CDMO) capabilities and advisory services to produce an adeno-associated virus (AAV)-based gene therapy, NT-Z001, for Phase I clinical trials.
  • To bring NT-Z001 to clinic, Navega will leverage Charles River’s off-the-shelf plasmid products, custom plasmid capabilities, and Good Manufacturing Practice (GMP)-grade AAV production.
  • Join Ana Moreno, CEO, Navega Therapeutics on March 19 in San Francisco – see the full agenda and save your seat: https://bit.ly/3SW3VOV
    “The collaboration with Navega will tap into our premier gene therapy CDMO capabilities and robust AAV offerings.

CBD Healthcare Company Becomes the First-Ever Worldwide to Earn Prestigious NSF International Certifications in Personal Care for Athletes (NSF Guideline 527 and NSF Certified for Sport)

Retrieved on: 
Friday, March 15, 2024
Sports, General Sports, Alternative Medicine, Other Health, Health, Cannabis, Specialty, Natural Resources, Cosmetics, Retail, Fitness & Nutrition, CFL, Solvent, Certification, Organization, Sport, Therapy, Dietary supplement, Risk, Senior ice hockey, National Hockey League, Good manufacturing practice, LPGA, Ironman, Selective androgen receptor modulator, AFL, Growth hormone, CBD, Massage, Athlete, NHL, GMP, Outline of health sciences, NSF, MLB, CCES, Diuretic, Former, USADA, Good, Sports medicine, Multimedia, NBA, PGA, THC, UFC, Steroid, NFL, NASCAR, Major League Baseball, Nursing

CBD Healthcare Company (CBDHCC) has become the First-Ever Personal Care Product to have earned certification to NSF Guideline 527 and NSF Certified for Sport® for its Broad-Spectrum CBD Balancing Massage and Body Oil.

Key Points: 
  • CBD Healthcare Company (CBDHCC) has become the First-Ever Personal Care Product to have earned certification to NSF Guideline 527 and NSF Certified for Sport® for its Broad-Spectrum CBD Balancing Massage and Body Oil.
  • "The spirit of clean athletic competition is something we all connect with,” said David Lonza, Vice President, Health Sciences at NSF.
  • NSF Certified for Sport® certifies dietary supplements, functional foods, cosmetics and personal care products to be free from substances banned by major sporting organizations.
  • Products Certified for Sport® must also be certified to either NSF/ANSI 173, NSF 229 or NSF 527 to ensure their contents match their claims.

Sensorion Reports Full-Year 2023 Financial Results and Business Update

Retrieved on: 
Thursday, March 14, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Bioreactor, Malignancy, Cell, Chemistry, Patient, Orphan, Good manufacturing practice, Health care, CMC, G&A, Molecular biology, Quality of life, European Medicines Agency, Science, Clinical trial, Cisplatin, Therapy, Hertz, Neoplasm, CIO, Congress, Huber loss, Partnership, Ageing, EMA, Hearing loss, GMP, Cochlea, Biochemistry, Safety, Language, Perilymph, G7, Medication, Control, AAV, PTA, IHC, Pasteur Institute, CDMO, Communication, Genetics, Research, KOL, Ear, POC, FDA, Ototoxicity, GJB2, ABR, CTA, ANSM, Audiogram, Platinum, Investment company, Congenital hearing loss, Pathology, Presbycusis, Hearing, Pharmaceutical industry

Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, today reports full-year 2023 financial results and business update.

Key Points: 
  • Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, today reports full-year 2023 financial results and business update.
  • Nawal Ouzren, Chief Executive Officer of Sensorion, said: “Over the past months, Sensorion has successfully achieved all the major milestones on its roadmap.
  • In the first half of 2023, Sensorion achieved a major development milestone by completing the preclinical package, and successfully producing the GMP dual AAV SENS-501 clinical batches at 200L scale.
  • On April 6, 2023, Sensorion announced the candidate selection for GJB2-GT during its gene therapy focused R&D Day.

Induced Pluripotent Stem Cells Market Report, Featuring Historical Revenue Data for 2021 and 2022, Estimated Figures for 2023, and Compound Annual Growth Rates (CAGRs) through 2028 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 12, 2024
Science, Stem Cells, Other Science, Biotechnology, Research, Pharmaceutical, Health, Clinical Trials, Cell, Stem cell, Fibroblast, B cell, Enzyme, Serum, Drug discovery, Row, Good manufacturing practice, Differentiable function, Neuron, GMP, Hepatocyte, Regenerative medicine, Medium (website), Antibody, Drug development, Geography, Astrocyte, IPSC, Endothelium

For instance, product function-based market segments include molecular and cellular engineering, cellular reprogramming, cell culture, cell differentiation, and cell analysis.

Key Points: 
  • For instance, product function-based market segments include molecular and cellular engineering, cellular reprogramming, cell culture, cell differentiation, and cell analysis.
  • An in-depth patent analysis and research funding analysis are also included to assess the overall direction of the iPSC market.
  • The induced pluripotent stem cell market has been analyzed for four main geographic regions: The U.S., Europe, Asia-Pacific, and the Rest of the World (RoW).
  • The report will provide details with respect to induced pluripotent stem cells.

Cellares Unveils First cGMP Compliant Cell Shuttle in its South San Francisco Center of Excellence

Retrieved on: 
Tuesday, March 12, 2024
Other Manufacturing, Medical Devices, Clinical Trials, Health Technology, Stem Cells, Manufacturing, Biotechnology, General Health, Pharmaceutical, Health, Failure, CDMO, Patient, CGMP, Good manufacturing practice, Safety, Workforce, Patient safety, Multimedia

The Cell Shuttle is an automated, ultra-high throughput, cell therapy manufacturing platform designed to meet global patient demand while reducing costs and process failure rates.

Key Points: 
  • The Cell Shuttle is an automated, ultra-high throughput, cell therapy manufacturing platform designed to meet global patient demand while reducing costs and process failure rates.
  • The release of this new version of the Cell Shuttle platform is an important milestone on the way to ensuring clinical readiness by the end of 2024.
  • View the full release here: https://www.businesswire.com/news/home/20240312686211/en/
    First cGMP Cell Shuttle & Cellares co-founders Omar Kurdi (left) and Fabian Gerlinghaus (right).
  • For more information about Cellares’ cGMP Cell Shuttle, please visit cellares.com/technology