CPC Scientific Passes FDA Pre-License Inspection for Hepcludex API Manufacturing
- CPC Scientific's Hangzhou cGMP facility completed FDA Pre-License Inspection (January–February 2026) for commercial manufacturing of Hepcludex® (bulevirtide-gmod) API, a long-chain synthetic peptide.
- The facility now supplies the FDA-approved HDV treatment API and expects validated capability to support future GLP-1 and obesity peptide programs.
- Successful inspection validates CPC's 25+ years of peptide manufacturing experience and positions the company for next-generation long-chain peptide regulatory filings.
Operational Impact
CPC Scientific's successful FDA inspection and validated commercial API manufacturing for Hepcludex® establishes a qualified long-chain peptide supply source for Gilead and signals capacity readiness for future GLP-1 and obesity peptide programs.
Source: PharmaSource RSS
Altruist Biologics Completes Commercial PPQ on 20,000L Bioreactors in Hangzhou
- Altruist Biologics completed its first commercial PPQ campaign using three consecutive batches on 20,000L stainless steel bioreactors at its Hangzhou site.
- Manufacturing costs for monoclonal antibody drug substance fell below $50 per gram through economies of scale, automation, and process optimization.
- The company plans to add four 20,000L and six 2,000L bioreactors by 2027, expanding total site capacity from 80,000L to 172,000L.
Operational Impact
Altruist Biologics' PPQ completion and sub-$50/gram mAb cost achievement at Hangzhou strengthens its competitive position for commercial-scale biologics manufacturing, while the 2027 capacity expansion to 172,000L adds significant APAC drug-substance supply for clients nearing commercial launch.
Source: PharmaSource RSS
Gland Pharma and Neuland Laboratories Launch Sterile API CDMO Partnership in India
- Gland Pharma will establish a dedicated sterile API manufacturing suite at its Visakhapatnam facility under a long-term partnership with Neuland Laboratories.
- The new suite adds ~1,400 kg of annual sterile API capacity and will operate under cGMP, U.S. FDA, and EU standards.
- Neuland Laboratories' board approved a ₹40 crore corporate guarantee to support the collaboration, combining both companies' API development and aseptic manufacturing expertise.
Operational Impact
Gland Pharma's new sterile API suite in Visakhapatnam adds 1,400 kg annual capacity for complex injectables, expanding APAC sterile API supply options for sponsors developing microparticle and depot formulations.
Source: PharmaSource RSS
Porton Advanced Gains China NMPA Class C License for Commercial CGT Manufacturing
- Porton Advanced received China's Class C Drug Manufacturing License from NMPA, enabling commercial-scale contract manufacturing of cell and gene therapy products.
- The license expands capabilities from process development and clinical production to commercial manufacturing under China's MAH regulations, following successful GMP inspection.
- Company reports 200+ global clients, 100% IND submission success rate, and support for 26 approved INDs; currently backing a cell therapy project nearing BLA submission.
Operational Impact
Porton Advanced's China commercial manufacturing license adds APAC capacity for cell and gene therapy CDMOs and may reduce geographic bottlenecks for sponsors advancing CGT programs toward BLA submission in China and globally.
Source: PharmaSource RSS
References
- PharmaSource RSS — CPC Scientific Passes FDA Pre-License Inspection for Hepcludex API Manufacturing
- PharmaSource RSS — Altruist Biologics Completes Commercial PPQ on 20,000L Bioreactors in Hangzhou
- PharmaSource RSS — Gland Pharma and Neuland Laboratories Launch Sterile API CDMO Partnership in India
- PharmaSource RSS — Porton Advanced Gains China NMPA Class C License for Commercial CGT Manufacturing