Biologics Consulting

biologicsconsulting.com

Biologics Consulting is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. In the nearly three decades since its founding, Biologics Consulting has become the go-to consulting partner for companies large and small seeking to bring innovative, safe and effective products to market in the US. Our team of consultants and professional services staff, is comprised of subject-matter experts with decades of industry and/or FDA experience that allows us to provide an unparalleled insider perspective.

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Industrial Impact

INVENTORS OF BIOLAYER INTERFEROMETRY TECHNOLOGY LAUNCH A NEXT GEN PLATFORM AND NOVEL BIOSENSORS

Gator Bio | September 15, 2021

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Gator Bio, Inc. announced today the launch of the GatorPlus, a next generation biolayer interferometry (BLI) instrument and two new biosensor products, Gator™ Flex SA Kit and Gator™ AAVX probe. The GatorPlus adds to the currently available GatorPrime instrument; and the new Gator™ Flex SA Kit and Gator™ AAVX probe expand the off the shelf biosensor portfolio to 14 products for the North America market. Gator Bio also offers on demand custom biosensors for specific applica...

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STEMCYTE SUBMITTED ITS APPLICATION FOR A BIOLOGICS LICENSE (BLA) FOR ITS PRODUCT "HPC-CORD BLOOD" TO THE US FDA

Stemcyte | March 23, 2022

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On January 7th, 2022, the FDA received the BLA (Biologics License Application) for the "HPC-Cord Blood" product. On March 8th, 2022, StemCyte was formally informed that the submission was acceptable to join the biologics license quality review process. The "HPC-Cord Blood" is an umbilical cord blood hematopoietic stem cell product intended for unrelated donor hematopoietic progenitor cell transplantation procedures in patients with hematopoietic system disorder...

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Industrial Impact

SARTORIUS STEDIM BIOTECH TO ACQUIRE ALBUMEDIX, STRENGTHENING ITS PORTFOLIO OF INNOVATIVE ADVANCED THERAPY SOLUTIONS

Sartorius Stedim Biotech | August 09, 2022

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Sartorius Stedim Biotech, a leading international partner of the biopharmaceutical industry, has agreed to acquire 100 percent of Albumedix Ltd. from private investors. The Nottingham, UK-based company provides best-in-class recombinant albumin-based solutions. Recombinant human albumin is an important component for the biopharmaceutical industry required for various applications, for example as an animal-free additive to cell culture media and for the stabilization of vaccines and viral therapi...

Read More

Industrial Impact

ENVISAGENICS ANNOUNCES RESEARCH COLLABORATION WITH BRISTOL MYERS SQUIBB

Envisagenics | December 05, 2022

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Envisagenics, an Artificial Intelligence driven biotechnology company that delivers therapies for RNA splicing diseases, today announced a research collaboration agreement with Bristol Myers Squibb. The multi-year collaboration will leverage Envisagenics' SpliceCore® AI platform to identify alternative splicing derived targets for therapeutic development to expand Bristol Myers Squibb's vast oncology pipeline. Envisagenics will receive an upfront payment and milestone payments based ...

Read More
news image

Industrial Impact

INVENTORS OF BIOLAYER INTERFEROMETRY TECHNOLOGY LAUNCH A NEXT GEN PLATFORM AND NOVEL BIOSENSORS

Gator Bio | September 15, 2021

Gator Bio, Inc. announced today the launch of the GatorPlus, a next generation biolayer interferometry (BLI) instrument and two new biosensor products, Gator™ Flex SA Kit and Gator™ AAVX probe. The GatorPlus adds to the currently available GatorPrime instrument; and the new Gator™ Flex SA Kit and Gator™ AAVX probe expand the off the shelf biosensor portfolio to 14 products for the North America market. Gator Bio also offers on demand custom biosensors for specific applica...

Read More
news image

STEMCYTE SUBMITTED ITS APPLICATION FOR A BIOLOGICS LICENSE (BLA) FOR ITS PRODUCT "HPC-CORD BLOOD" TO THE US FDA

Stemcyte | March 23, 2022

On January 7th, 2022, the FDA received the BLA (Biologics License Application) for the "HPC-Cord Blood" product. On March 8th, 2022, StemCyte was formally informed that the submission was acceptable to join the biologics license quality review process. The "HPC-Cord Blood" is an umbilical cord blood hematopoietic stem cell product intended for unrelated donor hematopoietic progenitor cell transplantation procedures in patients with hematopoietic system disorder...

Read More
news image

Industrial Impact

SARTORIUS STEDIM BIOTECH TO ACQUIRE ALBUMEDIX, STRENGTHENING ITS PORTFOLIO OF INNOVATIVE ADVANCED THERAPY SOLUTIONS

Sartorius Stedim Biotech | August 09, 2022

Sartorius Stedim Biotech, a leading international partner of the biopharmaceutical industry, has agreed to acquire 100 percent of Albumedix Ltd. from private investors. The Nottingham, UK-based company provides best-in-class recombinant albumin-based solutions. Recombinant human albumin is an important component for the biopharmaceutical industry required for various applications, for example as an animal-free additive to cell culture media and for the stabilization of vaccines and viral therapi...

Read More
news image

Industrial Impact

ENVISAGENICS ANNOUNCES RESEARCH COLLABORATION WITH BRISTOL MYERS SQUIBB

Envisagenics | December 05, 2022

Envisagenics, an Artificial Intelligence driven biotechnology company that delivers therapies for RNA splicing diseases, today announced a research collaboration agreement with Bristol Myers Squibb. The multi-year collaboration will leverage Envisagenics' SpliceCore® AI platform to identify alternative splicing derived targets for therapeutic development to expand Bristol Myers Squibb's vast oncology pipeline. Envisagenics will receive an upfront payment and milestone payments based ...

Read More