HEK293

Abeona Therapeutics Announces New Preclinical Data from its AAV Ophthalmology Program at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT)

Retrieved on: 
Tuesday, May 16, 2023
Tissue, Mouse, B cell, HEK 293 cells, Gene, ERG, RS1, Drug discovery, New product development, Mutation, RNA, AAV, CRE, Immunohistochemistry, Messenger, ABCA4, Animal, Ophthalmology, Cell, ISCB Senior Scientist Award, HEK293, Research, FDA, Therapy, Society, Treatment, Vaccine, Medical device, Silviculture

CLEVELAND, May 16, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced new data regarding three internally developed preclinical gene therapy product candidates from its adeno-associated virus (AAV) ophthalmology program that will be presented at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT), taking place from May 16-20, 2023 in Los Angeles, CA.

Key Points: 
  • CLEVELAND, May 16, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced new data regarding three internally developed preclinical gene therapy product candidates from its adeno-associated virus (AAV) ophthalmology program that will be presented at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT), taking place from May 16-20, 2023 in Los Angeles, CA.
  • Cre-mediated recombination of ABCA4 was confirmed by mRNA sequencing of RNA from transfected HEK293 cells and AAV-dosed animals.
  • RS1 expression was associated with improvement in cone photoreceptor density and increased thickness of the photoreceptor outer nuclear layer.
  • Following intravitreal injection in wild type mice, variants 1 and 7 showed robust protein expression.

Life Biosciences and Forge Biologics Announce cGMP Manufacturing Partnership to Advance Development of Novel Gene Therapies for Aging-Related Diseases

Retrieved on: 
Monday, May 8, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical Trials, Ignition, Partnership, Ageing, Multimedia, Medicine, AAV, CGMP, Patient, Toxicology, HEK293, Pharmaceutical industry, Hearth, Forge

Life Biosciences (“Life Bio”), a biotechnology company advancing innovative cellular rejuvenation technologies to reverse diseases of aging and injury and ultimately restore health for patients, and Forge Biologics (“Forge”), a genetic medicines manufacturing organization, today announced a manufacturing partnership to help advance Life Bio’s partial epigenetic reprogramming platform to address aging-related diseases, including its lead program targeting ophthalmic indications.

Key Points: 
  • Life Biosciences (“Life Bio”), a biotechnology company advancing innovative cellular rejuvenation technologies to reverse diseases of aging and injury and ultimately restore health for patients, and Forge Biologics (“Forge”), a genetic medicines manufacturing organization, today announced a manufacturing partnership to help advance Life Bio’s partial epigenetic reprogramming platform to address aging-related diseases, including its lead program targeting ophthalmic indications.
  • Through this partnership, Forge will provide adeno-associated virus (AAV) process development, toxicology, cGMP manufacturing, and analytical services to Life Bio.
  • All development and AAV manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy facility in Columbus, Ohio.
  • “We are delighted to be working with the Forge team, whose expertise in gene therapy manufacturing is unmatched,” said Jerry McLaughlin, Chief Executive Officer of Life Biosciences.

Tenaya Highlights Growing Capabilities in AAV Manufacturing, Capsid Engineering and Expansion into Gene Editing with Six Abstracts Accepted for Presentation at the ASGCT 26th Annual Meeting

Retrieved on: 
Wednesday, May 3, 2023
Heart, Abstract, Good manufacturing practice, Drug development, Gene, Heart failure, Cardiomyopathy, Gene editing, Survival, Research, AAV, PLN, Risk, SAN, Annual general meeting, Cell, American Society of Gene and Cell Therapy, Liver, HEK293, Arrhythmia, Therapy, HCM, Society, Disease, Pharmaceutical industry, Vaccine

“Tenaya was founded with a singular focus on developing novel medicines for rare and prevalent forms of heart disease.

Key Points: 
  • “Tenaya was founded with a singular focus on developing novel medicines for rare and prevalent forms of heart disease.
  • “The presentations at this year’s ASGCT highlight innovations in manufacturing, capsid engineering and gene editing, that support the advancement of our current pipeline and create new opportunities for future pipeline candidates.
  • At ASGCT, Tenaya researchers will present data detailing the scale up, formulation and purification techniques deployed in the successful initial manufacture of TN-201.
  • AAV9 is the current capsid of choice for cardiovascular indications and the capsid being used in Tenaya’s TN-201 and TN-401 gene therapy product candidates.

Catalent Expands UpTempo ℠ AAV Platform to Accelerate Development of Gene Therapies

Retrieved on: 
Thursday, March 9, 2023
CGMP, HEK293, EMA, Glossary, Patient, AAV, European Center for Constitutional and Human Rights, Transfection, Plasmid, Cell, Vaccine, Catalent

SOMERSET, N.J., March 9, 2023 /PRNewswire-PRWeb/ -- Catalent, the leader in enabling the development and supply of better treatments for patients worldwide, today announced the expansion of its UpTempo ℠  platform process for the development and CGMP manufacturing of adeno-associated viral (AAV) vectors. The platform now includes an in-house, clonal HEK293 cell line, and off-the-shelf plasmids to support a robust supply chain for the development and manufacture of gene therapies, and the reduction of timelines to first-in-human clinical evaluation.

Key Points: 
  • Catalent, the leader in enabling the development and supply of better treatments for patients worldwide, today announced the expansion of its UpTempo ℠ platform process for the development and CGMP manufacturing of adeno-associated viral (AAV) vectors.
  • The platform now includes an in-house, clonal HEK293 cell line, and off-the-shelf plasmids to support a robust supply chain for the development and manufacture of gene therapies, and the reduction of timelines to first-in-human clinical evaluation.
  • SOMERSET, N.J., March 9, 2023 /PRNewswire-PRWeb/ -- Catalent, the leader in enabling the development and supply of better treatments for patients worldwide, today announced the expansion of its UpTempo ℠ platform process for the development and CGMP manufacturing of adeno-associated viral (AAV) vectors.
  • "Speed to patients is paramount for gene therapy innovators, and as such, we've seen multiple customers requesting and signing up for the UpTempo platform.

Matinas BioPharma Provides Business Update and 2023 Strategic Outlook

Retrieved on: 
Monday, January 30, 2023
Transfer, Biomedical Advanced Research and Development Authority, RNA, Necessity and sufficiency, Disease, Lipofectamine, Food, Phase II, Safety, Oligonucleotide, Mycosis, Attention, HeLa, Mucormycosis, NYSE, BioNTech, Gene expression, Evaluation, Mucor, Sirna, Vaccine, ASO, Cryptococcosis, Aspergillosis, Survival, Therapy, Conference, Gilead, BARDA, Internal, COVID, HEK293, Patient, Enactment, Clinical trial, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Aspergillus, LNC, Organic acid, Hand, Candidiasis, Genentech, Coccidioidomycosis, Medicine, Asos, Development, RNA transfection, Sirna Therapeutics, Toxicity, Fine chemical, Pharmaceutical industry, Matina Brothers

ET

Key Points: 
  • ET
    BEDMINSTER, N.J., Jan. 30, 2023 (GLOBE NEWSWIRE) -- Matinas BioPharma (NYSE AMER: MTNB, Matinas), a clinical-stage biopharmaceutical company focused on redefining the intracellular delivery of nucleic acids and small molecules with its lipid nanocrystal (LNC) platform technology, today is providing a business update on its ongoing programs and discussing its strategic outlook for 2023.
  • Our ongoing collaborations with BioNTech and, recently, National Resilience, have aligned Matinas with two of the world’s leading companies in the gene therapy space.
  • The Company will host a live conference call and webcast to discuss this corporate update and 2023 business outlook today, Monday, January 30 at 4:30 p.m.
  • The live webcast will be accessible on the Investors section of Matinas BioPharma’s website, www.matinasbiopharma.com , and archived for 90 days.

Center for Breakthrough Medicines Amplifies Viral Vector Manufacturing Capabilities by Licensing Asimov's High-Performance GMP Suspension HEK293 Platform

Retrieved on: 
Wednesday, January 18, 2023
Heel, Senior, Therapy, Patient, Business development, Synthetic biology, Immortalised cell line, HEK293, CDMO, Investment, GMP, CBM, Vaccine, Pharmaceutical industry, Isaac Asimov

HEK293 cell lines are the industry standard for producing therapeutic viral vectors, the most widely used vehicle for the delivery of gene therapies.

Key Points: 
  • HEK293 cell lines are the industry standard for producing therapeutic viral vectors, the most widely used vehicle for the delivery of gene therapies.
  • "Many gene therapy developers need immediate access to a cell line for the production of their therapeutics.
  • Immediately available manufacturing capabilities supported by this clonal cell line will include both GMP manufacturing (up to 1000L scale) and non-GMP productions (up to 500L).
  • Our goal is to enable partners like CBM to improve vector titers, product quality, and bioreactor scalability, in order to increase access to advanced therapies."

Asimov and Center for Breakthrough Medicines Form Strategic Partnership for Viral Vector Production

Retrieved on: 
Wednesday, January 18, 2023
Partnership, Synthetic biology, CDMO, Therapy, Patient, Investment, Research, GMP, CBM, Immortalised cell line, Vaccine, Pharmaceutical industry, HEK293

As part of the partnership, Asimov has licensed its clonal GMP HEK293 suspension cell line to CBM for pre-clinical and clinical production of viral vectors for its clients.

Key Points: 
  • As part of the partnership, Asimov has licensed its clonal GMP HEK293 suspension cell line to CBM for pre-clinical and clinical production of viral vectors for its clients.
  • HEK293 cell lines are the industry standard for producing therapeutic viral vectors, the most widely used vehicle for the delivery of gene therapies.
  • "Our partnership with CBM is a major step forward in our goal to advance therapeutics manufacturing," said Alec Nielsen, CEO of Asimov.
  • By licensing our HEK293 viral vector production platform, CBM will be able to provide their clients with immediate access to reduce the cost of manufacturing these complex therapeutics."

Asimov and Center for Breakthrough Medicines Form Strategic Partnership for Viral Vector Production

Retrieved on: 
Wednesday, January 18, 2023
Partnership, Synthetic biology, CDMO, Therapy, Patient, Investment, Research, GMP, CBM, Immortalised cell line, Vaccine, Pharmaceutical industry, HEK293

As part of the partnership, Asimov has licensed its clonal GMP HEK293 suspension cell line to CBM for pre-clinical and clinical production of viral vectors for its clients.

Key Points: 
  • As part of the partnership, Asimov has licensed its clonal GMP HEK293 suspension cell line to CBM for pre-clinical and clinical production of viral vectors for its clients.
  • HEK293 cell lines are the industry standard for producing therapeutic viral vectors, the most widely used vehicle for the delivery of gene therapies.
  • "Our partnership with CBM is a major step forward in our goal to advance therapeutics manufacturing," said Alec Nielsen, CEO of Asimov.
  • By licensing our HEK293 viral vector production platform, CBM will be able to provide their clients with immediate access to reduce the cost of manufacturing these complex therapeutics."

Avirmax CMC Inc. Successfully Manufactured and Delivered to a Client the First Lot of rAAV Drug Product for a Monkey Toxicology Study

Retrieved on: 
Thursday, December 15, 2022
Process, Toxicology, Knowledge, Cros, QA, HEK293, Rita Raave, VG, Public health, ACI, Documentation, CGMP, California Department, Vaccine, Alipogene tiparvovec, Voretigene neparvovec

The manufacturing process was conducted in ACI's cGMP facility, recently licensed by California Department of Public Health (CDPH)-Food & Drug Branch, for the production of rAAV drug products for use in clinical investigations.

Key Points: 
  • The manufacturing process was conducted in ACI's cGMP facility, recently licensed by California Department of Public Health (CDPH)-Food & Drug Branch, for the production of rAAV drug products for use in clinical investigations.
  • Release testing of the rAAV product were performed in-house and by selected contract research organizations (CROs) in the U.S., thus speeding up the product release process.
  • The manufacturing platform contains orthogonal virus clearance technologies to ensure product virological safety.
  • It offers its clients with great transparency and flexible services with solid process development expertise, skills and knowledge in rAAV manufacturing, testing and quality management.

Thermo Fisher Scientific Introduces All-in-One AAV Production System for Scalable Gene Therapy Workflows and Commercial Applications

Retrieved on: 
Wednesday, November 16, 2022
Health, Genetics, Other Science, Research, Pharmaceutical, Science, AAV, PEI, Workflow, Invitrogen, Applied Biosystems, Thermo Fisher Scientific, Laboratory, Fisher Scientific, DNA, CTS, Science, Patheon, Cell, HEK293, Research, Transfection, Mindful Scientific Inc., CGMP, West Pharmaceutical Services, PPD, McKinsey & Company, Health, Patient, Vaccine

It features a mammalian-based suspension system comprised of a clonal HEK293 cell line and animal origin-free reagents that support scalable AAV production from shake flask to bioreactor scale.

Key Points: 
  • It features a mammalian-based suspension system comprised of a clonal HEK293 cell line and animal origin-free reagents that support scalable AAV production from shake flask to bioreactor scale.
  • Building on 60 years of trusted Gibco solutions, the CTS AAV-MAX System is the latest addition to our fit-for-purpose line of scalable solutions for commercial manufacturing of cell and gene therapy applications, said Amy Butler, president, biosciences, Thermo Fisher Scientific.
  • As part of Cell Therapy Systems (CTS) solutions, the CTS AAV-MAX System is designed to work within the AAV production workflow , from cell culture and transfection through AAV viral vector production.
  • Researchers can transition seamlessly from research on the Gibco AAV-MAX Helper Free AAV Production System to clinical scale using the CTS AAV-MAX System.