High-potent Dosage Forms up to OEB6

High-potent Dosage Forms up to OEB6
Product Description

We have the experience, expertise, and facilities at Sever Pharma Solutions to safely work with your high-potent substances. This includes manufacturing products containing APIs that are ranked in the highest occupational exposure bands (OEB) up to and including OEB6.

Our focus on safety starts immediately in early development, and we maintain this focus throughout the entire process. A coherent Safety, Health, and Environment (SHE) strategy has been implemented to ensure that all safety and environmental aspects are met.

Sever Pharma Solutions

  • Country/Region:
    Sweden
  • On CPHI since:
    2023
  • Certificates:
    2
  • Employees:
    250 - 499
Company types
CMO/CDMO
Primary activities
Contract Manufacturer
Specifications
  • Details
    Sever Pharma Solutions offers a comprehensive range of CDMO Services including HPAPI implant product development. Our expertise includes Polymer-Based Delivery Systems, Highly Potent Compounds (up to OEB6), Hormonal and Controlled DEA Substances (Schedule 3-5).   

    Polymer-Based Delivery Systems: Techniques used to manufacture solid dosage forms with a focus on achieving precise and controlled drug release. 

    Hot Melt Extrusion & Silicon Extrusion: High-capacity extrusion capabilities, including co-extrusion and conventional extrusion, ideal for manufacturing controlled-release intravaginal rings with excellent scalability. 

     Implants for Local Administration: Delivering API for local intra-tumoral or intra-ocular treatment up to OEB 6.  

     Silicone Injection Molding: Controlled drug delivery including hormones or hormonal treatments. 
     ...
  • Model
    Cytotoxic, Sex Hormones and other High Potent Dosage Forms up to OEB6

Sever Pharma Solutions

  • Country/Region:
    Sweden
  • On CPHI since:
    2023
  • Certificates:
    2
  • Employees:
    250 - 499
Company types
CMO/CDMO
Primary activities
Contract Manufacturer

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  • Hot Melt Extrusion

    Product Hot Melt Extrusion

    To successfully develop and manufacture your polymer-based delivery systems, like implants and intra-vaginal rings, we have advanced extrusion capabilities in Malmö (Sweden) and Putnam (US Connecticut). The US site is also a center of expertise for Hot Melt Extrusion (HME).

    HME improves the bioa...
  • Polymer-based delivery systems

    Product Polymer-based delivery systems

    Polymer-based dosage forms continuously administer the drug to the patient for an extended period, varying from weeks to years. These controlled-release products are very suitable for specific indications, patient populations, and drugs due to the long duration of action, avoidance of first-pass metabolism...

Sever Pharma Solutions resources (7)

  • News Sever Pharma Solutions expands partnership with Silo Pharma

    Sever Pharma Solutions, a leading Contract Development and Manufacturing Organization (CDMO) specializing in controlled release systems for high potent drugs, today announced an expanded agreement with Silo Pharma, Inc. (Nasdaq: SILO), a biopharmaceutical company developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments. Under the new agreement, Sever Pharma Solutions will scale up extrusion processes and continue analytical testing for Silo’s investigational SP-26 ketamine-loaded polymer implant targeting chronic pain and fibromyalgia.
  • Brochure Who we are - introduction to Sever Pharma Solutions

    Sever Pharma Solutions offers a comprehensive range of CDMO Services allowing us to support drug product development from start to finish. Our expertise includes Polymer-BasedDelivery Systems, Highly Potent Compounds (up to OEB6), Hormonal and Controlled DEA Substances (Schedule 3-5).
  • Video Inside Our Putnam Site: Purpose-Built for Your High Potent Projects

    Sever Pharma Solutions US site in Putnam, CT, features two fully commissioned and qualified High Potent API handling suites: One for development, one for GMP manufacturing. Designed with twin and single screw extrusion in mind, these suites bring flexibility, safety, and efficiency to your drug product development journey. From early-stage proof-of-concept in our ISO 8 development suite to seamless scale-up in our ISO 7 GMP suite, Putnam is engineered to eliminate unnecessary tech transfers and reduce timelines — without compromising quality or safety. See what makes Putnam a uniquely capable partner for your most challenging formulations.
  • Video Inside Our Malmö Site: Dedicated to GMP and non-GMP development

    Sever Pharma Solutions’ facility in Malmö, Sweden, features state-of-the-art suites dedicated to GMP and non-GMP development of polymer based delivery systems. Our Malmö site utilizes advanced polymer extrusion technologies for the production of implants, drug eluting intrauterine devices and intra-vaginal rings. The air circulation in the suites is single pass and state-of-the-art engineering controls are in-place for ensuring adequate containment for operator safety and prevention of cross-contamination. The recent addition of a three-layer co-extruder further enhances our offering, enabling the production of multilayered fibers with customized drug release profiles. Malmö is now uniquely positioned to streamline your drug development journey, delivering flexibility, safety, and efficiency.
  • Whitepaper Design of intra-vaginal drug-releasing rings

    Download our free whitepaper on the design of intra-vaginal drug-releasing rings (IVRs) and the importance of avoiding unnecessary design complexity. You will also get the background on IVR development, which includes polymer selection and drug release kinetics, and learn more about simultaneous drug release.
  • Whitepaper A COMPARISON OF SATURATED SOLUBILITY ENHANCEMENT VIA SPRAY DRYING AND HOT MELT EXTRUSION PROCESSING

    Solid solutions are similar to liquid solutions and consist of a single phase irrespective of the number of components. A solid solution of a poorly water-soluble drug dissolved in a carrier is particularly interesting in improving oral bioavailability. In a solid solution, the drug’s particle size has been reduced to its molecular dimensions resulting in a more rapid dissolution rate. By judicious selection of a carrier, the dissolution rate of the drug can be increased by up to several orders of magnitude. In a solid solution, the drug’s particle size has been reduced to its molecular dimensions resulting in a more rapid dissolution rate.

    This whitepaper compares solubility enhancement between spray drying and hot melt extrusion for a poorly soluble, new active pharmaceutical ingredient.

  • Whitepaper ANALYTICAL TOOLS & TECHNIQUES IN HOT MELT EXTRUSION - CASE STUDY ON PROCESS SCALE UP

    Hot melt extrusion has been widely used as a processing method for many purposes, including forming a solid molecular dispersion to increase the bioavailability of poorly soluble drugs. Analytical tools and techniques can significantly reduce time and improve success rates in developing hot melt extrusion formulations.

    In the scale-up phase, analytical characterization techniques ensure similar solubility enhancement occurs on larger extrusion equipment as with the lab scale equipment used for formulation development.

    In this whitepaper, you will learn more about the analytical characterization and techniques that are critical in the scale-up of melt-extruded solid dispersions to ensure similar products are produced, specifically in obtaining similar solubility-enhancing effects.