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Solvent-free technology expands manufacturing options for poorly soluble oral drug candidates.
By: Charlie Sternberg
The designation applies to the site’s BCM3 antibody intermediate and conjugated drug substance dual-function production line, and DP4 facility.
By: Patrick Lavery
Decisions around trial design, regulatory strategy, and manufacturing planning ultimately determine whether a therapy reaches patients.
By: Kristin Brooks
Next-gen engineered enzyme designed to make the critical step of converting RNA to cDNA faster.
MT027 previously received Orphan Drug Designation, and T-Maximum was authorized to start a Phase II study.
QbD, digital platforms, and risk-based, paperless validation approaches can dramatically accelerate project delivery, reduce inspection findings, and improve documentation efficiency.
By: Sachin Maled
miRecule’s proprietary precision RNA design platform is combining with RBBL’s expertise in peptide discovery, development, and manufacturing.
Jideytro, a ROS1 selective inhibitor, previously received Breakthrough Therapy and Orphan Drug designations.
Davird Pirman promoted to EVP and Head of Discovery; Bruce Car transitions to Chief Innovation Officer; Warren Volles designated Executive Officer.
The designation supports commercial manufacturing for a potential blockbuster autoimmune therapy.
J.TRAIN is designed to enable biopharma companies to increase capacity and manufacture biologics at reduced costs and improved productivity.
Aveta’s first-in-class immunotherapy has U.S. FDA Fast Track and Orphan Drug designations.
Reimagining trial design from static protocols to predictive simulation.
By: Raja Shankar
The freezing and thawing platform is designed for maximizing process consistency and product quality for high-value biologics.
Collaboration will use Protillion’s protein design AI platform to discover novel therapeutic candidates.
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