Woodstock Sterile Solutions, Inc.

Woodstock Sterile Solutions is a leading contract development and manufacturing organization (CDMO) specializing in advanced aseptic blow-fill-seal (BFS) technology for sterile liquid pharmaceutical formulations. The company provides end-to-end services from clinical-stage development through large-scale commercial production of solutions, suspensions, and emulsions. Their proprietary BFS process forms, fills, and seals product containers in seconds under aseptic conditions, minimizing human intervention and contamination risk. The company has decades of expertise in ophthalmic and respiratory drug delivery systems and has extended capabilities to temperature-sensitive biologics and large-molecule formulations through patented processing techniques that control heat impact during manufacturing. Woodstock offers flexible manufacturing options including standard bottle sizes and custom-designed containers, specialized handling for potent materials (Safebridge 1-4 certified), and unique aseptic insertion technology for tip/cap assemblies. They serve pharmaceutical and biopharmaceutical companies across multiple regulatory environments. The facility is FDA-registered for drug, device, and food manufacturing; holds state licenses for wholesale drug manufacturing and distribution; maintains ISO 13485:2016 certification; and possesses manufacturing accreditations for the EU, Japan, Australia, Canada, and Brazil. The company emphasizes API stewardship, regulatory expertise, and streamlined scale-up pathways to accelerate time to market.