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|January 1, 2015
- BioPharm International-01-01-2015
- Volume 28
- Issue 1
Sterile Vent Increases Precision
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Meissner’s Sterile Process Design vent for use in sterile filtration processes features a knurled knob to improve ease-of-use with gloved hands. The vent is designed with multi-flow initiation to allow for precision flow metering, with an optimized 1/8” hose barb for single-use tubing.
The fully captured assembly eliminates the risk for accidental over-actuation, damage, or removal of the vent during use. The dual vent stem seals maintain a sterile process envelope and a polymeric sealing technology simplifies the materials of construction by removing the need for O-ring seals.
Meissner Filtration Products
Articles in this issue
almost 12 years ago
Great Expectations from New European Commissionalmost 12 years ago
Analyzing Protein Aggregation in Biopharmaceuticalsalmost 12 years ago
Raw Materials and the Development Cyclealmost 12 years ago
Fill/Finish Capacity Use for Biologicsalmost 12 years ago
Politics and Patients to Shape Pharma in 2015almost 12 years ago
Standards Organizations Updatealmost 12 years ago
Adopting the Product Lifecycle Approachalmost 12 years ago
Ligand-Binding Assays and the Determination of Biosimilarityalmost 12 years ago
Drug Breakthroughs, with Some Reservationsalmost 12 years ago
Technologies and Practices Must Evolve to Meet DemandAdvertisement
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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.
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