Connecting All Your Dots
Bioconjugation, coming soon
Bioconjugation Without Fragmentation
Simtra BioPharma Solutions is extending its proven sterile injectable formulation and fill/finish expertise upstream into bioconjugation — creating a more integrated drug substance (DS) to drug product (DP) solution under one roof, one quality system and one cross-functional team. Our pharma and biopharma partners benefit from the agile collaboration, streamlined processes and timeliness intrinsic to our approach.
Simplicity and Flexibility With a Single CDMO
With Simtra, organizations gain all the advantages of working with one highly adaptable development and manufacturing partner. Simtra helps accelerate the path from drug substance to drug product and enables customers to choose the conjugation science that best fits their molecule as well as the right drug development methodologies and production scale to meet their needs.
Simplified Single-CDMO Execution
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Fewer handoffs
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Operational DS/DP synergies
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Integrated analytical platform
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Decreased testing needs
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Reduced supply chain risk
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Dedicated project manager
Full Flexibility
- Platform-agnostic conjugation approach
- Ability to process all commonly used starting materials
- Cytotoxic and non-cytotoxic payloads
- Liquid and lyophilized drug formulation development
- Fill/finish operations on site
- Clinical and commercial production capacity
Integrated Bioconjugate Drug Manufacturing With Simtra
Following the receipt of active pharmaceutical ingredients from the customer or another organization, Simtra’s work begins with drug substance bioconjugation, proceeds to drug product formulation development and moves seamlessly through to quality-first sterile fill/finish operations at clinical or commercial scale, with extensive testing all along the way. Our GMP-compliant manufacturing process is designed to help mitigate risk with specialized containment capabilities, a dedicated WFI system and single-use disposables.
Deep Scientific and Technical Expertise
Simtra brings long experience and focused expertise to bioconjugate drug manufacturing:
- 10+ years in manufacturing bioconjugate drugs
- 20+ years in lyophilization development and optimization
- Mastery of critical process parameters, resulting from early-stage involvement
- Transfer of more than 60 bioconjugate drug programs for 15 distinct clients, including 6 commercially approved products
Get in Touch
Our dedicated bioconjugation suite is coming soon.
We invite you to tell us about your upcoming bioconjugate drug project.