Interim phase 1/2 data presented at Retina in Rio 2026 showed sustained visual improvements with Opus Genetics’ AAV8 gene therapy OPGx-LCA5 and improved retinal sensitivity with OPGx-BEST1 in inherited retinal diseases.
|Articles|March 15, 2014
- BioPharm International-03-15-2014
- Volume 2014 eBook
- Issue 1
Configuring Manufacturing Operation Management Applications
Author(s)Gloria Gadea-Lopez, PhD
Adopting single-use systems has implications for manufacturing execution systems, process data-analytics tools, and scheduling
Advertisement
Adopting single-use systems has implications for manufacturing execution systems (MES), process data-analytics tools, and scheduling. Enterprise resource planning and MES must be integrated using standards such as ISA-95. Master and electronic batch records must be designed to capture the details of single-use component assembly to enable traceability.
Read
Articles in this issue
over 12 years ago
Achieving Supply Chain Excellence in Single-Use Systemsover 12 years ago
Innovation in Pre-packed Disposable Chromatography Columnsover 12 years ago
Single-Use Technology in Downstream Processingover 12 years ago
Single-Use Technology for Syringe FillingAdvertisement
Related to this article
Nathan Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
Mirikizumab (Omvoh) achieved comprehensive disease control in 27.7% of UC patients and deep remission in 20.4% with Crohn disease at 1 year.
As ArsenalBio, TScan, Bristol Myers Squibb, and others abandon ex vivo programs for in vivo engineering, early clinical data and platform differences point to both the promise and the unresolved safety, manufacturing, and regulatory questions of generating CAR-T cells inside the body.
BNT113 plus pembrolizumab failed to significantly extend progression-free survival in a 285-patient HPV16-positive head and neck cancer trial.
Gilead will develop up to three PRO-XTEN T-cell engagers discovered by Vir Biotechnology for solid tumors in a deal worth up to $1.74 billion.
The FDA has accepted Pierre Fabre Pharmaceuticals’ resubmitted BLA for tabelecleucel, an allogeneic T-cell immunotherapy for EBV+ post-transplant lymphoproliferative disease. The FDA’s target action date is March 31, 2027.
Johnson & Johnson's guselkumab achieved up to 29% fistula remission in hard-to-treat Crohn disease subgroups, including prior biologic failures.
Advertisement
Advertisement
Trending on BioPharm International
1
BioPharm Brief: Gene Therapy Progress, FDA Approval, and $103M Funding
2
Opus Genetics’ OPGx-LCA5 Gene Therapy Shows Sustained Vision Gains Ahead of Phase 3
3
FDA Approves Roche’s Enspryng as First At-Home Subcutaneous Treatment for Thyroid Eye Disease
4
After the Pivot: What In Vivo Cell Therapy Offers, and What It Still Has to Prove
5