Cambrex Case Studies
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Optimized Stability Storage
8/23/2024
A healthcare manufacturer facing space constraints and regulatory pressures outsourced their stability storage needs to another company, resulting in reduced costs and focus on core competencies.
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Implementing A Disaster Recovery Plan
8/23/2024
When facing a malfunction, having an effective disaster recovery plan can make the difference between a swift fix, and losing your samples and time.
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Strategic Space Management
8/23/2024
A pharmaceutical company facing storage space issues decided to outsource its reference samples to Q1 Scientific, a stability storage service provider, resulting in cost savings.
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Demonstrating Control Over The Manufacturing Process: QbD Studies
1/24/2022
Understand the importance of fate and purge studies, which measure the ability of the process to remove impurities and provide evidence of their removal.
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Pinpoint Manufacturing Steps That Require Tighter Control
1/24/2022
With a complete picture of the parameters that control each step during manufacturing, chemists can monitor and control individual reactions to optimize the overall production process.
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Route Development: Designing Synthesis For GMP Production
1/24/2022
The successful transition from initial synthesis of an API to a kilogram-scale route requires expert analysis and design, and a balance of economic, regulatory, and time constraints.
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Rapid Characterization Of Impurities
1/24/2022
Understand how to manage impurities in drug development with swift isolation, synthesis, and analysis. A client discovered an impurity during ongoing stability studies that exceeded ICH guidelines.
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Qualified Reference Standards: Setting The Standard For Product Quality
1/24/2022
Qualified reference standards play a critical role in providing validated benchmarks to satisfy regulatory requirements pertaining to purity.
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Peptide Synthesis: Delivering Cost-Effective Strategies
1/24/2022
For peptide APIs, using a liquid phase peptide synthesis (LPPS) approach offers a cost-effective process for large-scale manufacture by eliminating the need for specialized equipment and excess raw materials.
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Crystallization Process Development: Peptide Crystallization
1/24/2022
Whether performed during formation of an API or as a means to purify intermediates, achieving control of nucleation and crystal growth is critical to designing a successful peptide crystallization process.