SK pharmteco Opens Small-Molecule and HPAPI Manufacturing Expansions in Ireland
- SK pharmteco completed two GMP facilities at its Swords, Ireland campus: a multi-purpose small-molecule API facility with 26.5 m³ reactor capacity (three 8,000 L reactors) and a kilo-scale HPAPI/ADC payload facility supporting batch sizes up to 1.5 kg.
- The HPAPI facility handles ultra-high-potency compounds with occupational exposure limits as low as 10 ng/m³, featuring isolators, high-pressure chromatography, and lyophilization to bridge clinical and commercial GMP production.
Operational Impact
SK pharmteco's Swords expansions add 26.5 m³ of small-molecule reactor capacity and dedicated kilo-scale HPAPI/ADC manufacturing, reducing clinical-to-commercial transition risk for potent-compound programs in Europe.
Source: Contract Pharma Breaking News RSS
Cytovance Biologics Launches Standalone Analytical Services for Biologics Development
- Cytovance Biologics now offers analytical services independently of manufacturing engagements, covering method development, validation, characterization, release testing, and stability studies.
- Services span early-stage through commercial programs under both GMP and non-GMP environments, targeting sponsors with limited internal lab capacity.
Operational Impact
Cytovance's standalone analytical model reduces switching costs for sponsors evaluating manufacturing partners, allowing them to validate analytical readiness before committing to manufacturing capacity.
Source: PharmaSource RSS
Andelyn Biosciences to Manufacture AAV9-GM2 Gene Therapy for Queen's University
- Andelyn Biosciences, a cell and gene therapy CDMO, will develop and manufacture AAV9-GM2, a gene therapy candidate for GM2 gangliosidoses including Tay-Sachs and Sandhoff diseases.
- Andelyn will deploy its AAV Curator Platform to execute a multi-phase manufacturing program to support clinical dosing of the therapy.
Operational Impact
Andelyn expands its AAV gene therapy manufacturing footprint by adding a multi-phase GM2 program, demonstrating continued capacity deployment in rare-disease viral-vector manufacturing.
Source: Contract Pharma Breaking News RSS
Piramal Pharma Increases Yapan Bio Stake to 74% for $7.95M, Bolsters ADC Platform
- Piramal Pharma acquired an additional 40.67% stake in Hyderabad-based CDMO Yapan Bio for ₹76 crore ($7.95M), raising total ownership to 74% and making it a subsidiary.
- Integration expands Piramal Pharma Solutions' large-molecule capabilities and strengthens its ADCelerate platform for antibody-drug conjugate development from Phase I through GMP in 12 months.
Operational Impact
Piramal Pharma Solutions gains integrated large-molecule and ADC manufacturing capacity in India, enabling its ADCelerate platform to compress Phase I-to-GMP timelines to 12 months and address rising demand for complex biologics outsourcing.
Source: PharmaSource RSS
Genprex Partners with U.S. CDMO for AAV Diabetes Gene Therapy Scale-Up
- Genprex signed a development and manufacturing agreement with an unnamed U.S. CDMO to scale cGMP production of its AAV-based diabetes gene therapy.
- The partnership covers process optimization, bioreactor scale-up, analytical development, and drug product supply for IND-enabling studies and clinical trials.
- Manufacturing activities target improved production efficiency, increased dose availability for multicenter trials, and regulatory-compliant potency and stability assurance.
Operational Impact
The unnamed CDMO gains AAV gene-therapy manufacturing volume for a Phase-1-stage diabetes program requiring multicenter trial capacity and commercial-scale bioreactor infrastructure.
Source: PharmaSource RSS
References
- Contract Pharma Breaking News RSS — SK pharmteco Opens Small-Molecule and HPAPI Manufacturing Expansions in Ireland
- PharmaSource RSS — Cytovance Biologics Launches Standalone Analytical Services for Biologics Development
- Contract Pharma Breaking News RSS — Andelyn Biosciences to Manufacture AAV9-GM2 Gene Therapy for Queen's University
- PharmaSource RSS — Piramal Pharma Increases Yapan Bio Stake to 74% for $7.95M, Bolsters ADC Platform
- PharmaSource RSS — Genprex Partners with U.S. CDMO for AAV Diabetes Gene Therapy Scale-Up