Simtra BioPharma Solutions
Contract development and manufacturing organization (CDMO) focused on sterile injectable products. Offers integrated development and manufacturing services spanning formulation development, lyophilization, analytical testing, technology transfer, clinical supply and commercial fill/finish across multi-site cGMP facilities in the United States and Germany. Operates audited, ISO 14001-aligned facilities and supports global regulatory submissions and distribution.
Industries
Nr. of Employees
Very Large (1000+)
Simtra BioPharma Solutions
Contact pages: https://simtra.com/contact-us/ and meeting request: https://simtra.com/contact-us/request-a-meeting/
Products
Liquid vials (multi- and single-dose)
Aseptic-filled liquid vial formats for clinical and commercial use.
Lyophilized (freeze-dried) vials
Lyophilized vial formats supported by lyophilization development and cycle optimization.
Prefilled syringes and diluent syringes
Prefilled syringe platforms and diluent syringe products with dedicated filling capabilities.
Liquid vials (multi- and single-dose)
Aseptic-filled liquid vial formats for clinical and commercial use.
Lyophilized (freeze-dried) vials
Lyophilized vial formats supported by lyophilization development and cycle optimization.
Prefilled syringes and diluent syringes
Prefilled syringe platforms and diluent syringe products with dedicated filling capabilities.
Services
End-to-end product development services including formulation design, solubility and stability assessments, excipient screening, lyophilization feasibility and cycle optimization, analytical method support and manufacturability assessments to accelerate entry to clinical trials.
Clinical and commercial-scale sterile fill/finish for liquid and lyophilized vials, prefilled syringe formats and diluent syringes with containment options for cytotoxics and highly potent compounds, plus inspection and packaging.
Transfer of processes and analytical methods into manufacturing, execution of validation batches and qualification activities to support regulatory submissions and commercial launch.
End-to-end product development services including formulation design, solubility and stability assessments, excipient screening, lyophilization feasibility and cycle optimization, analytical method support and manufacturability assessments to accelerate entry to clinical trials.
Clinical and commercial-scale sterile fill/finish for liquid and lyophilized vials, prefilled syringe formats and diluent syringes with containment options for cytotoxics and highly potent compounds, plus inspection and packaging.
Transfer of processes and analytical methods into manufacturing, execution of validation batches and qualification activities to support regulatory submissions and commercial launch.
Expertise Areas
- Sterile injectable fill/finish
- Lyophilization development and cycle optimization
- Cytotoxic and highly potent compound handling
- Antibody-drug conjugate (ADC) and bioconjugate manufacturing
Key Technologies
- Aseptic fill–finish
- Lyophilization (freeze-drying)
- High-containment barrier/isolation technology
- Prefilled syringe filling lines
News & Updates
Industry event focused on antibody-drug conjugates (ADC).
Head of Development discusses ADCs, accelerated timelines and integration of development services.
Facilities audited by multiple regulatory authorities and products distributed in more than 120 countries.
Completed construction of a new production manufacturing building at the Halle/Westfalen, Germany campus.
Industry event focused on antibody-drug conjugates (ADC).
Head of Development discusses ADCs, accelerated timelines and integration of development services.
Facilities audited by multiple regulatory authorities and products distributed in more than 120 countries.
Completed construction of a new production manufacturing building at the Halle/Westfalen, Germany campus.