Sever Pharma Solutions

State-of-the-art manufacturing and fully automated assembly and visual inspection for prefilled syringes and autoinjectors.

Precision manufacturing of sterile, ready-to-use injectable solutions that combine quality, safety and convenience.

Expertise and facilities required to work with high-potent substances, including APIs ranked up to and including OEB6.

Specialized CDMO services for highly potent APIs up to OEB6 and DEA Controlled Substances.

Advanced polymer drug delivery manufacturing, drug implant manufacturing, vaginal ring manufacturing, and amorphous solid dispersion manufacturing using hot-melt extrusion technology.

Sever Pharma Solutions offers CMO capacity concerning the aseptic filling of syringes and assembly and packaging of pre-filled syringes and auto-injectors, utilizing single-use materials to prevent contamination.

Expedited development and manufacture of investigational medicinal products for all stages of clinical development, supporting various batch sizes and active substances in high occupational exposure bands (OEB5) with polymer-based drug manufacturing capabilities.

Injection molding technology for the production of polymer-based dosage forms.

Oral dosage forms developed and manufactured using Hot Melt Extrusion tailored to meet desired profiles for drug release.

Late-phase clinical trial supply, process validation, registration batch manufacture, and commercial scale-up for pharmaceutical products and combination devices.

Technology and manufacturing transfer services aligned with ISPE Good Practice Guide: Technology Transfer, covering transfer from R&D to production and between production sites.

Early-stage product development services including screening, computational modeling, and formulation development to demonstrate proof of technical feasibility for pharmaceutical products.

Compliant serialization service according to customer requirements with Tracelink interface, enabling Track and Trace capabilities and compliance with DSCSA and EU Falsified Medicines Directive legislation.

Comprehensive primary and secondary packaging services for standard-size bottles, pouches, and blisters with customized packaging design and source high-quality materials.