In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|October 26, 2021
Charles River Laboratories to Expand Vivarium Capacity in Cambridge
Author(s)BioPharm International Editors
The planned expansion will expand the capacity of the Charles River Accelerator and Development Lab (CRADL).
Advertisement
Charles River Laboratories announced a planned expansion of the Charles River Accelerator and Development Lab (CRADL) in Cambridge, Mass., on Oct. 20, 2021. In addition to a 30,000 ft² expansion to its existing facilities on Binney Street, a new 18,000 ft² location is being planned.
CRADL is a ready-to-use vivarium rental space used in various animal studies that is intended to eliminate concerns of animal husbandry and daily vivarium management. CRADL also provides access to Charles River’s existing portfolio of in-vivo support services such as transgenic model creation, animal health surveillance, and more.
“In the biopharmaceutical industry, both infrastructure and staffing can be prohibitively expensive and take significant time to develop,” said Julie Freebersyser, director of CRADL operations at Charles River, in a company press release. “CRADL alleviates that burden by providing best-in-class vivarium space and management to both emerging and established institutions. By outsourcing their vivarium space, researchers can focus on research, instead of logistics.”
Source:
Advertisement
Related to this article
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
Detalimogene voraplasmid produced a 56% complete response rate in BCG-unresponsive bladder cancer, with an estimated 43% of responses lasting a year.
FDA has cleared Biolojic Design’s IND for BD200, a bispecific antibody-drug conjugate targeting Trop2 and Nectin-4 whose arms can each bind either target. A global Phase 1 study in solid tumors is expected to begin in the coming weeks.
Blackstone Life Sciences will fund up to $1.5 billion of development costs through 2028 for Pfizer’s monthly GLP-1 receptor agonist berobenatide, in exchange for milestone payments tied to approval and sales. Pfizer keeps full control of the program.
Gene-corrected nula-cel freed all 3 RESTORE patients from transfusions, with sickle hemoglobin below 20% in the 2 followed for over 6 months.
Beam Therapeutics’ base-edited cell therapy risto-cel meets its primary endpoint in the BEACON sickle cell disease trial, Amgen’s CD40L antagonist dazodalibep reduces systemic disease activity in the phase 3 OASIZ-301 Sjögren’s disease trial, and ImvivaBio’s allogeneic CD19/BCMA CAR-T CTA313 sustains lupus remission through 12 months.
Matt Truppo, Richard Jaenisch, and Brian Drapeau examine AI's impact on drug success, human oversight, data governance, and biopharma's future.
Advertisement
Advertisement
Trending on BioPharm International
1
ImvivaBio’s Dual-Target Allogeneic CAR-T Sustains Lupus Remission Through 12 Months
2
Updates on Simtra BioPharma Solutions’ Bloomington Capacity Expansions
3
Amgen’s Dazodalibep Reduces Systemic Disease Activity in Phase 3 Sjögren’s Trial
4
Beam's Risto-cel Meets Primary Endpoint in Sickle Cell Trial
5