ImmuPharma Selects Thermo Fisher for Kapiglucagon Drug-Product CDMO Services
- ImmuPharma engaged Thermo Fisher Scientific as CDMO for Kapiglucagon, a glucagon prodrug targeting Type 1 diabetes.
- Thermo Fisher will support CMC activities, pharmaceutical development, and IND-enabling manufacturing for the program's advance toward clinical development.
- ImmuPharma plans accelerated development including a 505(b)(2) regulatory pathway, with funding secured for the next two years.
Operational Impact
Thermo Fisher's selection as DP CDMO for Kapiglucagon adds a Type 1 diabetes glucagon-prodrug program to its small-molecule development portfolio, supporting CMC and manufacturing through IND submission.
Source: PharmaSource RSS
SK pharmteco Advances AAV Gene Therapy to Phase III with 20 Clinical Batches for Genethon DMD Program
- SK pharmteco's Yposkesi French facility has manufactured 20 AAV8 batches at 400 L scale, including 18 cGMP batches, supporting Genethon's GNT-0004 gene therapy from Phase I/II through Phase III authorization.
- Phase III trial for DMD launched in Europe and UK in 2025 following EMA and MHRA approvals; SK pharmteco continues manufacturing clinical supply and preparing commercial-scale documentation and process validation.
- Partnership demonstrates SK pharmteco's viral vector manufacturing capabilities and positions its French operations to support additional late-stage viral vector programs in Europe and beyond.
Operational Impact
SK pharmteco's demonstrated ability to scale AAV8 production to 400 L cGMP batches and navigate EMA/MHRA approvals for a pivotal Phase III trial reinforces its viral vector CDMO capacity in Europe and positions the French facility to absorb additional late-stage gene therapy programs.
Source: PharmaSource RSS
Restore Vision Selects Forge Biologics for RV-001 AAV Gene Therapy Manufacturing
- Forge Biologics will provide process development, cGMP manufacturing, analytical development, stability testing, and regulatory consultation for RV-001, an AAV gene therapy targeting retinitis pigmentosa.
- Manufacturing will occur at Forge's 200,000-square-foot Columbus, Ohio facility, with drug product shipped to Japan to support Phase 1/2 clinical trials.
Operational Impact
Forge Biologics' Columbus facility is now committed to AAV process development and cGMP manufacturing for a Phase 1/2 gene therapy program with Japan-based clinical supply, demonstrating CDMO capacity allocation in the gene therapy segment.
Source: PharmaSource RSS
References
- PharmaSource RSS — ImmuPharma Selects Thermo Fisher for Kapiglucagon Drug-Product CDMO Services
- PharmaSource RSS — SK pharmteco Advances AAV Gene Therapy to Phase III with 20 Clinical Batches for Genethon DMD Program
- PharmaSource RSS — Restore Vision Selects Forge Biologics for RV-001 AAV Gene Therapy Manufacturing