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, 2022
Cambrex Announces Stability Storage Expansions in Ireland and Belgium
Author(s)BioPharm International Editors
Cambrex has expanded its stability storage business, Q1 Scientific, in Ireland and Belgium.
Advertisement
Cambrex announced on Oct. 4, 2022 the expansion of Q1 Scientific, its stability storage business, which offers environmentally controlled stability storage services to the pharmaceutical, medical device, and life sciences industries. Its existing facility in Waterford, Ireland will have an additional 10,000 ft2 expansion, and a new 20,000 ft2 current good manufacturing practices (CGMP) facility will be opened in Belgium.
The new temperature-controlled and monitored storage facility in Belgium will be located in the Liege region. The facility will provide 35,000 temperature-controlled storage spaces. The Waterford-based Ireland facility has doubled in size over the past two years and continues to grow with this new 10,000 ft2 expansion.
“With Cambrex’s scientific expertise and scale, we are able to accelerate our growth plans and launch a second site in 2023,” said Stephen Delaney, managing director of Q1 Scientific, in a company press release. “Operating two sites will be a great benefit to our European customers, who can now expect even faster turnaround times for the return of samples. Meanwhile, we will also be able to provide greater temperature-controlled transport options in mainland Europe.”
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