MannKind Licenses SemBioSys' Plant-Produced Insulin
MannKind Corporation (Valencia, CA) has purchased an option to license plant-produced recombinant human insulin from SemBioSys Genetics Inc. (Calgary, Canada) for use primarily in MannKind's ultra-rapid acting insulin, Afresa.
MannKind Corporation (Valencia, CA) has purchased an option to license plant-produced recombinant human insulin from SemBioSys Genetics Inc. (Calgary, Canada) for use primarily in MannKind’s ultra-rapid acting insulin, Afresa.
SemBioSys' plant-produced insulin is human insulin produced from genetically enhanced safflower. More information about the plant-produced insulin can be found on the BioPharm web site.
SemBioSys has demonstrated that its plant-produced insulin is physically, structurally, and functionally indistinguishable from pharmaceutical-grade human insulin through analytical testing and preclinical sub-chronic toxicology studies in rodents and primates. SemBioSys is currently conducting a Phase 1–2 clinical trial of its plant-produced insulin. The three-arm study of up to 30 healthy volunteers is designed to demonstrate the bioequivalence of safflower-produced insulin to two commercial insulin standards. Full results are expected to be available during the first half of 2009.
The option expires on March 31, 2009. Mannkind has completed Phase 3 trials of Afresa and expects to file a new drug application for Afresa early this year.
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Novartis Acquisition of Regulus Therapeutics is Complete
June 25th 2025A key property included in the acquisition is farabursen, an investigational next-generation oligonucleotide targeting the microRNA miR-17 with preferential kidney exposure, intended to treat people with autosomal dominant polycystic kidney disease.
