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Formulation Development for
Sterile Injectable Manufacturing

Scientific and Technical Expertise
for Adept Problem Solving

In our decades of partnership with pharmaceutical and biotechnology companies for sterile injectable manufacturing, we have used our scientific and technical expertise to solve a broad range of issues that come with product formulation development. These include questions related to dosage forms (solution, suspension, freeze-dried), reformulation, drug stability, solubility, chemical degradation, component compatibility, leachables and extractables, and precipitation. We can also assess delivery options and product component compatibility. Our team of experienced scientists is equipped with state-of-the-art instrumentation and equipment.

Industrywide Collaboration for Continual Progress

Our scientists participate in consortia with industry groups and universities dedicated to advancing scientific and technical knowledge and contribute to standard-setting organizations such as USP and the Parenteral Drug Association. Whether your product is a biologic or a small molecule, standard or complex, clinical or commercial, our experts stand ready to develop and implement formulation decisions aimed at optimizing product quality throughout manufacturing.

Explore These Critical Capabilities

  • Lyophilization Cycle Development and Optimization

    Using advanced technology to assist clients with lyophilization cycle development and optimization.

  • Rapid Technology Transfer

    Ensuring rapid technology transfer through strong partnership.

  • Analytical Services

    Offering robust analytical capabilities to ensure stringent quality assurance and precise testing.

Contact Us

Learn more about our formulation development services.

Related Resources

Best Practices in Formulation and Lyophilization Development

For protein, mAb and ADC products, lyophilized formulations provide the greatest probability of technical success.

Scale-Up and Tech Transfer

When lyophilized products move from lab- to full-scale production, considering the differences in equipment design and capability aids in process scale-up and transfer.

Process Development for Lyophilized Products

Simtra approaches formulation and process development for a lyophilized product by identifying the failure points for the product.