PHARMA ONLINE WHITE PAPERS

• Correlating Laser-Based Headspace Analysis To Helium Leak Rate Testing

  Laser-based headspace analysis is a non-destructive and rapid method for testing container closure integrity. We demonstrate that headspace analysis is equally as sensitive as helium leak rate testing.

• Oligonucleotide Synthesis: Scale-Up Made Simple

  10/16/2024

  Scaling oligonucleotide synthesis isn't as straightforward as it seems. Explore key challenges, critical process parameters, and solutions for a smooth scale-up.

• ICH Q12 Implementation: Regulatory Intelligence And PACM Agility

  7/9/2024

  Here, we outline a practical framework designed to assist companies in implementing ICH Q12 from day one, enabling them to realize its benefits early on and paving the way for continuous improvement.

• Microbial Challenge In-Use Studies

  6/13/2024

  Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.

• Spray Drying To Enable New Inhaled Drug Products

  7/11/2023

  The formulation and spray drying process can help manufacture a stable, highly respirable powder and deliver products that require a high drug load, a biologic, or rapid onset therapeutic.

• Streamlining Change Control For CDMOs

  2/26/2024

  Here, we outline a holistic approach for CDMOs to streamline the change control process, aiming to enhance quality, compliance, and time-to-market.