Curia Invests $28M to Expand Sterile API Manufacturing in Spain
- Curia is investing $28 million to expand sterile API manufacturing at its Valladolid, Spain facility, with completion targeted for Q4 2028.
- The expansion will support both steroid and non-steroid injectable suspensions and complex sterile formulations, with manufacturing flexibility from grams to metric tons using closed-system barrier isolators.
- The project builds on Curia's May 2026 completion of a $4 million aseptic suite upgrade at the same site, strengthening integrated R&D, analytical, and manufacturing services.
Operational Impact
Curia's Valladolid sterile API expansion adds European GMP capacity for injectable suspensions and complex sterile formulations, offering CDMO buyers variable batch-size manufacturing and reduced contamination risk through barrier-isolator technology by late 2028.
Source: PharmaSource RSS
Catalent Launches 10-Month Gene-to-Drug Substance Program for Complex Biologics
- Catalent introduced an accelerated U.S. program delivering bispecifics and multispecifics from gene sequence to drug substance in 10 months, complementing its existing 8-month mAb timeline.
- The offering integrates GPEx® Lightning cell line development with development and manufacturing workflows, with three customer-facing milestones: master cell bank conditional release (month 7), bulk drug substance shipment (month 9), and lot release (month 10).
- The program bridges early development to clinical supply and positions Catalent's integrated drug substance and drug product capabilities for fill-finish readiness.
Operational Impact
Catalent's 10-month complex biologics program with defined milestones (month 7 cell bank, month 9 bulk shipment, month 10 release) offers CDMO buyers a predictable compressed timeline for next-generation molecules entering clinical development.
Source: PharmaSource RSS
Flamma Acquires Lundbeck's Padova API Site, Adding 220 m³ Italian Capacity
- Flamma will acquire Lundbeck Pharmaceuticals Italy's Padova facility, adding 220 m³ of cGMP API manufacturing capacity effective January 1, 2027.
- The site brings Flamma's total Italian capacity to ~1,100 m³ across four Northern Italy locations, with capabilities in hydrogenation, micronization, high-pressure and hazardous chemistry.
Operational Impact
Flamma's four-site Northern Italy cluster and expanded 1,100 m³ capacity strengthen its small-molecule API and peptide supply capability for commercial-stage clients seeking European manufacturing proximity.
Source: PharmaSource RSS
Genezen to Manufacture AAV8 Gene Therapy for InterAct Therapeutics Breast Cancer Program
- Genezen will provide AAV process development, scale-up, and GMP manufacturing for InterAct Therapeutics' IAT-S2, an AAV8-based gene therapy targeting breast cancer liver metastases.
- Manufacturing support covers toxicology studies and clinical material production for a planned Phase 1 trial following positive FDA INTERACT feedback.
Operational Impact
Genezen's Indianapolis GMP facility adds AAV8 manufacturing capacity for a Phase 1-stage gene therapy program, demonstrating continued demand for specialized AAV CDMO services in oncology.
Source: PharmaSource RSS
References
- PharmaSource RSS — Curia Invests $28M to Expand Sterile API Manufacturing in Spain
- PharmaSource RSS — Catalent Launches 10-Month Gene-to-Drug Substance Program for Complex Biologics
- PharmaSource RSS — Flamma Acquires Lundbeck's Padova API Site, Adding 220 m³ Italian Capacity
- PharmaSource RSS — Genezen to Manufacture AAV8 Gene Therapy for InterAct Therapeutics Breast Cancer Program