ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• USP Draft Chapters On CCS: What You Need To Know

  Learn why it's important to stay aligned with evolving Annex 1 expectations to support sterility assurance, regulatory compliance, and patient safety across sterile drug manufacturing operations.

• Leachables Method Development, Validation And Relevant ICH References

  It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.

• USP <382>: Think Systems, Not Components

  This blog focuses on the application of USP <382> prescribed testing to cartridges and syringes from a mechanical testing perspective.

• Strategies For Accelerating The Development Of Modified Release Oral Forms

  Careful selection of appropriate excipients and delivery technologies is key to the design of modified release (MR) formulations fulfilling specific performance requirements.

• Achieve Release Profiles And Select Excipients For Formulation Development

  The formulation and manufacture of modified-release OSD forms are highly specialized. Review considerations for planning and executing a successful modified release oral solid dosage formulation.

• Maintaining Superior Viral Vector Recovery In Cell And Gene Therapy Applications

  A study assessing the stability of vials aimed to determine if the vial material had any influence on the viral titer and particle counts of the AAV serotypes.

• Building Sustainability Into Medical Devices

  Medical device waste is a growing problem in the pharmaceutical industry. Learn how to navigate the balance between sustainability and factors like performance, safety, and regulatory compliance.

• Considerations In Formulation Development Of Injectable Solutions

  Injectable solutions offer an alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability, and suitability of administration under hospital setting.

• Solutions For Accelerated Pharmaceutical Development

  Explore an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties such as low aqueous solubility and poor bioavailability.

• Achieving New Heights By Expanding Services, Talent, And Facilities

  As you aim to reduce costs and ensure on-time delivery, discover the opportunities for drug formulation and commercial supply that can advance your therapy to the clinic and beyond.