A real-world study found evolocumab cut fatal or nonfatal heart attack risk 20% vs ezetimibe in adults with ASCVD and prior statin use.
|Articles|September 1, 2016
- BioPharm International-09-01-2016
- Volume 29
- Issue 9
Analyzer Automates Cell-Culture Chemistry Analysis
The BioProfile FLEX 2 from Nova Biomedical is a cell-culture chemistry analyzer that allows for automated cell-culture analysis for small-volume culture systems.
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The BioProfile FLEX 2 from Nova Biomedical is a cell-culture chemistry analyzer that allows for automated cell-culture analysis for small-volume culture systems. The system incorporates Nova’s MicroSensor Card technology, which minimizes sensor maintenance. The FLEX 2 provides analysis of 16-cell culture chemistries including Gluc, Lac, Gln, Glu, NH4+, Na+, K+, Ca++, pH, pCO2, pO2, osmolality by freezing point depression, and total and viable cell density and viability by trypan blue dye exclusion method. The full panel of tests can be run in under four minutes with 265 microliters of sample, and users can select from manual sampling or two modes for batch sampling: 96-well plates or the built-in 24-position tray. Designed for small volume, early-stage cell culture development through GMP manufacturing, BioProfile FLEX 2 provides 21 CFR Part 11 compliance, OPC connectivity, full networking functionality, and support with all validation needs.
Articles in this issue
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Parenteral Advisory: Outmoded Fill/Finish Technologyabout 10 years ago
Process Chromatography Selection for Downstream Processing Applicationsabout 10 years ago
Data Logger Provides Ultra-Low Temperature Readingsabout 10 years ago
Manufacturing and Distribution Boundaries Blurabout 10 years ago
Modeling Bioreactor Performanceabout 10 years ago
Implementing a Dual Approach to Protein Characterizationabout 10 years ago
Efforts Accelerate to Streamline Postapproval Change Processabout 10 years ago
Innovation vs. Capacity: How CMOs CompeteAdvertisement
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FDA grants accelerated approval to Johnson & Johnson’s subcutaneous EGFR/MET bispecific Rybrevant Faspro for previously treated head and neck squamous cell carcinoma, T-Therapeutics raises a $133 million Series B to take TCR-CD3 bispecifics into clinical trials, and Alethio Therapeutics raises a $90 million Series A to advance its first-in-class G6B antibody for essential thrombocythemia.
Johnson & Johnson's amivantamab (Rybrevant Faspro) won accelerated FDA approval for pretreated recurrent head and neck cancer.
Oxford spinout Alethio Therapeutics closed a $90 million Series A to take ATX-011, a monoclonal antibody against the G6B receptor, into Phase 1/2a studies in essential thrombocythemia. It is also developing a G6B-targeted ADC for myelofibrosis.
T-Therapeutics closed an oversubscribed $133 million Series B backed by Eli Lilly, JJDC, and others. The funding will take its first T-cell receptor bispecifics in cancer and autoimmune disease into clinical trials.
China’s NMPA grants priority review to Akeso’s PD-1/VEGF bispecific ivonescimab with chemotherapy for first-line biliary tract cancer, VeonGen Therapeutics aligns with FDA on a phase 3 design for its dual-AAV Stargardt gene therapy VG801, and Caldera Therapeutics’ IL-23p19×TL1A bispecific CLD-423 shows a half-life of more than 40 days in a phase 1a trial.
FDA’s draft framework would let sponsors add patient-specific genome editing variants to an approved BLA using in vitro data. Here is what the guidance proposes, what evidence it asks for, and what remains unresolved.
Healthy-volunteer data show sustained TL1A suppression and a profile supporting infrequent subcutaneous dosing. Caldera also licensed a second bispecific, targeting IL-17 and TL1A, from Qyuns Therapeutics.
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