Clinical and commercial manufacturing frequently become a major bottleneck in drug development. Limited sterile capacity, variability in CMO technical maturity, challenges in high-viscosity filling, and the absence of scalable manufacturing platforms can delay timelines, escalate cost of goods (COGs), and jeopardize regulatory acceptance. Complex dosage forms—including ophthalmics, injectables, semisolids, transdermals, and drug–device combination products—require CMOs with specialized infrastructure, high-containment systems, and demonstrated experience with global regulatory filings. Selecting an ill-suited partner can trigger re-validation cycles, packaging inconsistencies, supply disruptions, or even long-term commercial non-viability.
Healios eliminates these risks by providing end-to-end technical consulting and CMO identification for both clinical trial supplies and commercial manufacturing. Leveraging deep process-engineering expertise, QbD-driven manufacturability assessments, and global regulatory intelligence, we match sponsors with CMOs capable of delivering reliability, scalability, and long-term compliance. Our network of 50+ vetted CMOs spans the USA, India, Europe, UK, Canada, Japan, South Korea, Taiwan, China, and APAC, covering all dosage forms Healios supports—topicals, transdermals, ophthalmics, otics, injectables (SVP/LVP), nasal sprays, implants, inserts, and oral liquids.
Advanced CMO Capabilities Identified by Healios
- Flexible batch sizes—from gram-scale feasibility batches to multi-metric-ton commercial campaigns
- Advanced processing technologies: hot-melt extrusion, cryogenic milling, nanomilling, micronization, emulsification engineering, continuous manufacturing
- High-viscosity and complex fill-finish for ophthalmic gels, long-acting injectables, emulsions, suspensions, and semisolids
- Integrated drug–device development including device design, prototyping, tooling, assembly, fill–finish, and performance qualification
- Aseptic and terminal sterilization (steam, EtO, gamma, e-beam)
- High-containment manufacturing for hormonal, cytotoxic, potent, and controlled-substance products
- Comprehensive packaging and serialization across BFS, vials, PFS, cartridges, HDPE, laminate tubes, sprays, pumps, blisters, unit-dose formats
- GDP-compliant global logistics, cold-chain management, and clinical supply distribution
Healios exclusively partners with USFDA-, EMA-, MHRA-, Health Canada-, and PMDA-audited CMOs that maintain rigorous global GMP compliance. These facilities operate with robust quality systems, validated equipment trains, strong documentation controls, and proven inspection histories. With highly experienced technical and QA teams, they deliver consistent supply reliability, reproducible batch performance, and regulatory-ready documentation—from master batch records to technology-transfer packages and CMC modules—supporting seamless progression into global markets.
As part of our long-term expansion strategy, Healios is developing an ophthalmic BFS platform and an injectable LVP sterile facility in New Jersey, further strengthening our ability to support development-to-commercial readiness.
