HEK293

PharmaCyte Biotech Successfully Completes Cytochrome P450 Site of Integration DNA Sequencing Assay

Retrieved on: 
Wednesday, December 8, 2021
Biotechnology, Diabetes, Health, Genetics, Oncology, Cell, U.S. Securities and Exchange Commission, Pancreatic cancer, Nanopore, LAPC, Company, Neoplasm, Biotechnology, Technology, PMCB, Private Securities Litigation Reform Act, IND, Food, HEK293, Liver, DNA, Nanopore sequencing, Form, Immortalised cell line, Cancer, Diabetes, Form 10-K, Capsule, FDA, NASDAQ, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Ifosfamide, Insulin, Pharmaceutical industry, Medical imaging

We can report that the DNA sequence analysis of the cytochrome P450 2B1 augmented cells is now complete, and it is a great challenge that is now behind us.

Key Points: 
  • We can report that the DNA sequence analysis of the cytochrome P450 2B1 augmented cells is now complete, and it is a great challenge that is now behind us.
  • The FDA requested that the exact sequence of the cytochrome P450 2B1 gene inserted at that location should also be determined.
  • This is technologically challenging because the introduced DNA is large and concatenated, causing the Company to turn to nanopore sequencing technology for this analysis.
  • Nanopore sequencing is a cutting edge, unique and scalable technology that enables direct, real-time analysis of long DNA fragments.

Artisan Bio to present CRISPR-engineered cell therapies at Meeting on the Mesa

Retrieved on: 
Monday, October 11, 2021
Cell engineering, Doctor of Philosophy, Data analysis, CHO, Mesa, HEK293, CRISPR, Cell, Potency (pharmacology), CEO, Solution, STAR, Technology

DENVER, Oct. 11, 2021 /PRNewswire/ --Artisan Bio, Inc. will present their STAR platform used for precision cell engineering at the 2021 Cell & Gene Meeting on the Mesa on October 12, 2021 in Carlsbad, California.

Key Points: 
  • DENVER, Oct. 11, 2021 /PRNewswire/ --Artisan Bio, Inc. will present their STAR platform used for precision cell engineering at the 2021 Cell & Gene Meeting on the Mesa on October 12, 2021 in Carlsbad, California.
  • Ryan T. Gill, PhD, CEO of Artisan Bio, will provide an overview of the company's technology platform and data from partnered collaborations.
  • The Cell & Gene Meeting on the Mesa brings together industry-leading researchers, executives, and decision-makers to advance cutting-edge research into tomorrow's newest therapy.
  • By engaging in strategic collaborations with innovative partners, Artisan seeks to deliver customizable cell engineering solutions that meet the complexities associated with next-generation cell therapies.

Solid Biosciences and Forge Biologics Announce Viral Vector Contract Development and cGMP Manufacturing Partnership

Retrieved on: 
Monday, October 4, 2021
Other Manufacturing, Research, Genetics, Stem Cells, Manufacturing, Biotechnology, Pharmaceutical, Health, Science, Other Science, Ignition, Duchenne muscular dystrophy, Partnership, The Hearth, Security (finance), CDMO, Therapy, CGMP, Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, FDA, Multimedia, Patient, Program, Family, Disease, DMD, IGNITE, IND, Safety, AAV, Nasdaq, Mutation, HEK293, Pharmaceutical industry, Forge Biologics, Solid Biosciences, FORGE BIOLOGICS, SOLID BIOSCIENCES

Solid Biosciences Inc. (Solid, Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), and Forge Biologics, a cell and gene therapy-focused contract development and manufacturing organization (CDMO), announced a partnership to advance the development and manufacturing of SGT-003, Solids next generation gene therapy program for Duchenne.

Key Points: 
  • Solid Biosciences Inc. (Solid, Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), and Forge Biologics, a cell and gene therapy-focused contract development and manufacturing organization (CDMO), announced a partnership to advance the development and manufacturing of SGT-003, Solids next generation gene therapy program for Duchenne.
  • View the full release here: https://www.businesswire.com/news/home/20211004005324/en/
    Forge will provide an adeno-associated viral (AAV) vector process, scale-up engineering and cGMP manufacturing services for SGT-003.
  • All development and cGMP manufacturing activities will occur at The Hearth, Forges 175,000 ft2 gene therapy cGMP production facility in Columbus, Ohio.
  • Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company.

Forge Biologics Announces Regulatory Updates from FDA and EMA, Accelerating Manufacturing and Clinical Trial Momentum

Retrieved on: 
Monday, September 20, 2021
FDA, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Ignition, COMP, Muscle weakness, Hearing loss, The Hearth, Peripheral neuropathy, Therapy, European Medicines Agency, CGMP, FDA, Psychosine, Multimedia, Patient, Regulatory affairs, Hematopoietic stem cell transplantation, Irritability, Quality, Death, GALC, European Union, Krabbe disease, Disease, Technology, HEK293, Peripheral nervous system, Union, Research, Brain, Cell, AAV, Lipid, EMA, Galactosylceramidase, Pharmaceutical industry, Vaccine, Krabbe Disease, FBX-101, Orphan Designation, Forge Biologics, KRABBE DISEASE, FBX-101, ORPHAN DESIGNATION, FORGE BIOLOGICS

FBX-101 previously received Orphan Drug and Rare Pediatric Disease Designations from the FDA earlier this year.

Key Points: 
  • FBX-101 previously received Orphan Drug and Rare Pediatric Disease Designations from the FDA earlier this year.
  • Forge presented information to the FDA on its proprietary HEK293 suspension cell line, Ignition Cells, and adenovirus helper plasmid, pEMBR, and received FDA alignment that these technologies are suitable for cGMP manufacturing of clinical drug products.
  • The Hearth is a custom-designed cGMP facility dedicated to AAV vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing.
  • By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most.