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 15, 2009
SAFC Pharma Expands Facility to Bolster Biologics Manufacturing
Author(s)Chitra Sethi
SAFC Pharma has announced the completion of an addition to its Carlsbad, CA, facility, which specializes in the process development and manufacturing of viral vaccines and viral therapeutics.
Advertisement
SAFC Pharma has announced the completion of an addition to its Carlsbad, CA, facility, which specializes in the process development and manufacturing of viral vaccines and viral therapeutics. The new expansion, designed for multi-lot campaigns, includes dedicated cell expansion, bioreactor production, purification, and cleanroom suites.
The $12-million project includes the addition of two fully segregated viral product manufacturing suites, built to use the latest in disposable bioreactor technologies. This expansion will expand SAFC Pharma's biologics, viral vaccines, and gene therapy manufacturing to commercial-scale quantities.
The company has added 8,000 sq. ft. of manufacturing space to the existing 44,000 sq. ft. site, which will enable both 100-L batch production in stirred-tank bioreactors and 1,000-L batch manufacturing in disposable bioreactors. Designed from the outset as a containment facility, the expansion space will allow clients to secure a dedicated suite of cleanrooms for large-scale manufacturing.
Facility validation studies are currently underway for the additional suites, with an expected start of cGMP manufacturing operations by the end of December 2009.
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
Blackstone to Provide Pfizer Up to $1.5 Billion for Monthly GLP-1 Berobenatide Development
3
Updates on Simtra BioPharma Solutions’ Bloomington Capacity Expansions
4
The BioPharm Brief: An AI-Designed Multibody ADC Enters the Clinic, Blackstone Backs Pfizer’s Monthly GLP-1, and enGene Readies a Bladder Cancer BLA
5