Newsletter | November 20, 2023

11.20.23 -- FDA Releases Q&A Guidance On Human Factors Engineering For Combination Products


FDA Releases Q&A Guidance On Human Factors Engineering For Combination Products

Developing an effective combination product can be easily undone, often as a direct result of design limitations. To support the co-packaged design process, the FDA has issued new guidance titled Application of Human Factors Engineering Principles for Combination Products: Questions and Answers.


Spray-Drying Advancements For Enhanced Bioavailability

In a recent webinar, Lonza discussed the process it uses to develop a spray-dried powder formulation and scale from early feasibility studies to manufacturing.

Selecting An Alternative Coating Technology For Prefillable Syringes

The challenges of silicone-oil lubrication and the growing trend for more viscous, protein-based drugs are now leading pharma and biotech companies to investigate alternative solutions.

Ensure Speed And Success With Your Drug Delivery Project

Hear from experienced professionals in the drug delivery space on how to ensure success and speed-to-market by establishing a firm foundation when working with a CMO.

Empowering A New Era Of Patient-Centric Medicines

Discover the challenges pharma companies are facing as they switch focus, as well as the actions and technologies companies are implementing to help achieve a brighter future for patients.

Developmental Testing Of IV Solutions

As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.

Crystallization Process Development: Peptide Crystallization

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.

Taste Masking 101: Sensory And Performance Evaluation

Learn how techniques and innovations in taste masking sensory and performance evaluation can help accelerate your formulation development and confirm desired taste profile.

Avoiding The Pitfalls Of LNPs And Complex Formulations

Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.


Nasal Spray Development And Manufacturing Services

End-To-End Drug Development, Analytical Testing, And Fill/Finish

Sterile Formulation And Fill/Finish For Early-Phase Clinical Trials

Modified-Release Formulation Strategies