Sever Pharma Solutions
Sever Pharma Solutions is a dedicated CDMO specializing in high potent drug development, controlled-release systems, and polymer-based delivery solutions. With a history dating back to the 1970s, the company offers end-to-end services including formulation development, manufacturing, and research, with facilities in Malmö, Sweden, and Putnam, CT, USA. They focus on innovative pharmaceutical solutions to improve drug stability, efficacy, and patient outcomes, and are recognized for their advancements in controlled-release systems and high-potent drug manufacturing.
Industries
Products
Polymer-based implants and inserts (controlled release)
Implantable and insertable polymer-based drug delivery systems designed for long-acting, controlled release of potent APIs.
Vaginal rings (controlled-release)
Polymer-based intravaginal rings configured for sustained release of APIs for local or systemic prophylactic or therapeutic use.
Pre-filled syringes and auto-injector assemblies
Aseptically filled pre-filled syringes and assembled auto-injectors for high-potent injectable drugs, with integrated assembly and packaging services.
Solid oral dosage forms manufactured via HME
Oral tablets and capsules produced from hot melt extruded amorphous solid dispersions to enhance solubility and dissolution of poorly water-soluble APIs.
Polymer-based implants and inserts (controlled release)
Implantable and insertable polymer-based drug delivery systems designed for long-acting, controlled release of potent APIs.
Vaginal rings (controlled-release)
Polymer-based intravaginal rings configured for sustained release of APIs for local or systemic prophylactic or therapeutic use.
Pre-filled syringes and auto-injector assemblies
Aseptically filled pre-filled syringes and assembled auto-injectors for high-potent injectable drugs, with integrated assembly and packaging services.
Solid oral dosage forms manufactured via HME
Oral tablets and capsules produced from hot melt extruded amorphous solid dispersions to enhance solubility and dissolution of poorly water-soluble APIs.
Services
Development services
Formulation and process development for polymer-based and controlled-release dosage forms, small-scale prototyping, proof-of-concept extrusion and scale-up support for clinical and commercial programs.
Analytical services
Analytical characterization and method development for HME formulations and solid dispersions using microscopy, thermal analysis, spectroscopy, dissolution testing and chromatographic assays.
Regulatory affairs services
Regulatory strategy, dossier support and guidance for drug–device combination products, Quality by Design implementation, QTPP, risk assessments and design control documentation for US and EU submissions.
Manufacturing services
GMP manufacturing including high-containment HPAPI suites, hot melt extrusion at clinical and commercial scale, aseptic fill and finish for syringes, injection molding and assembly/packaging for auto-injectors and rings.
Development services
Formulation and process development for polymer-based and controlled-release dosage forms, small-scale prototyping, proof-of-concept extrusion and scale-up support for clinical and commercial programs.
Analytical services
Analytical characterization and method development for HME formulations and solid dispersions using microscopy, thermal analysis, spectroscopy, dissolution testing and chromatographic assays.
Regulatory affairs services
Regulatory strategy, dossier support and guidance for drug–device combination products, Quality by Design implementation, QTPP, risk assessments and design control documentation for US and EU submissions.
Manufacturing services
GMP manufacturing including high-containment HPAPI suites, hot melt extrusion at clinical and commercial scale, aseptic fill and finish for syringes, injection molding and assembly/packaging for auto-injectors and rings.
Expertise Areas
- Controlled-release polymer-based drug delivery
- High-potency API (HPAPI) development and containment
- Hot-melt extrusion formulation and scale-up
- Aseptic sterile manufacturing for high-potent injectables
Key Technologies
- Hot melt extrusion (HME)
- Twin-screw extrusion
- Single-screw extrusion
- Co-extrusion