Certified: ISO/IEC 17025:2017 accreditation, FDA drug establishment registration, EMA GMP certificates
About this item
Accelerate your gene-edited autologous programs, including CAR-T and TCR-T programs, through proven process development, GMP manufacturing, and in-house testing, reducing vein-to-vein time and improving patient access.
Support scalable, off-the-shelf therapies including NK, HSC, and iPSC platforms with integrated analytics and regulatory expertise.
Provide end-to-end support for non-edited allogeneic therapies, combining robust platforms, global GMP facilities, and QC testing to enable reliable cell supply.
Ensure consistency, scalability, and faster turnaround for patient-specific therapies, from early-phase to commercial supply.
Accelerate programs from discovery through commercial supply with extensive experience in vaccine characterization and lot release.
Integrated viral vector services span plasmid design, process development, and GMP manufacturing for AAV and LVV platforms, supported by proprietary TESSA® and XOFLX™ technologies.
Three-tiered biosafety approach ensures regulatory compliance and accelerated release timelines for mAbs, including characterization, purification process evaluation, and lot release.
Description
Pure‑play Cell Therapy CDMO and Gene Therapy CDMO delivering process development, cGMP manufacturing, and commercial supply.
End-to-End Cell Therapy Services
We offer a low-risk, seamless scale-up from Phase 1 to commercial production, with global quality systems that ensure regulatory compliance. Integrated biosafety testing and product characterization services expedite vein-to-vein turnaround times.
Expert & Seamless Tech Transfer
We help early-phase clients avoid tech transfer issues and specialize in late-phase and commercial tech transfer for smooth, large-scale transitions. We offer scalable solutions to overcome manufacturing limitations, reducing costs and improving efficiency.
Process Development & Scale-Up
Our team has expertise in cell and gene therapies, as well as in drug products and will tailor your process for scale, consistency, optimization, and GMP readiness. Our experts minimize risks and delays while quickly demonstrating safety and efficacy.
Viral Vector Supply & Manufacturing
We offer comprehensive lentiviral and AAV platforms, from early-stage screening and optimization to process development and manufacturing scale-up for clinical and commercial applications.
Plasmid Engineering
SnapFast™ modular plasmids enable easy, reliable insertion and allow the creation of custom constructs across various expression platforms. Use our off-the-shelf SnapFast™ plasmids or collaborate with us to design custom plasmids.
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