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WHITE PAPERS AND CASE STUDIES

• From Problem To Performance: A Custom Filter That Transformed Imaging Quality

  IDEX Health & Science solved a multi-band fluorescence imaging challenge by designing Semrock filters with ultra-deep blocking, steep edges, and wider passbands for exceptional image quality.

• Biotech Delivers A Superior Patient And Site Experience

  To become the sponsor of choice for sites and patients in congenital hyperinsulinism clinical trials, a small biotech company prioritized delivering a superior experience while streamlining operations.

• ProPharma Supports A Contract Manufacturer's Form 483 Response

  Learn how a small contract manufacturer navigated a complex FDA 483 Observation notice and implemented effective remediation strategies that addressed multiple system-wide concerns.

• Scalable Production Of High-Purity Nanobodies Using Yeast Expression System

  Leverage scalable K. pastoris expression systems to produce high-quality nanobodies for cutting-edge therapeutic, diagnostic, and research applications.

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• Mobilizing Compliance: USP 797 And 800 Pharmacy Trailer Fleet For VA Hospitals

  VA hospitals across the US are undergoing renovations to bring their facilities into compliance. The challenge was to design and manufacture a fleet of self-sufficient mobile compounding pharmacies.

• Turnkey Dismantling, Modification, And Relocation Of A Multi-Glove Isolator System

  Strategic equipment relocation and retrofitting can reduce capital costs by fifty percent and save months in lead time. Learn how to modernize legacy systems while maintaining full GMP compliance.

• Revolutionizing Pharmaceutical Quality Control

  Learn about a South Korean pharmaceutical company's QC laboratory and how the operation of its chromatography systems has been transformed by implementing a real-time monitoring system.

• Navigating The European Market's Regulatory Complexities

  Prepare your EU launch strategy with this comprehensive guide detailing what is needed to ensure compliance and efficiency in the EU market.

• Quality By Design: Better Data Using Participant Insights

  While clinical trials will always encounter challenges in driving quality experiences and data, there is one approach that’s backed by regulatory agencies and proven to lead to better outcomes.

• Robust, Scalable Strategy For Monodisperse Nanosuspensions Of Poorly Soluble Drugs

  By tailoring the formulation strategy, selecting the appropriate excipients, and fine-tuning process conditions, see how our team was able to improve bioavailability and in vivo exposure.

• Improving API Solubility

  Ensuring adequate solubility is crucial for small molecule drugs' effectiveness. Find out how poor solubility remains a significant challenge, potentially hindering medications from reaching the market.