ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• A Guide To Optimize Analytical Strategies Throughout Biologics Development

  A miscalculated analytical approach can be costly to develop, perform, and maintain. Many organizations also lack appropriate resources to create optimal testing methods and protocols.

• Gaps In Reconstitution Process Filled By Water-For-Injection Syringe

  The recent rise in biopharmaceutical drugs has sparked renewed interest in lyophilization as a way to bring injectable biologics and other drugs to market more quickly.

• Solid Form Screening, Rapid Formulation Selection To Meet Tight Timelines

  A comprehensive approach to evaluating drug molecules for the selection of a lead solid form and formulation can significantly accelerate development timelines and limit risks in later development.

• Patient-Centric Formulations In Pediatric Adherence

  Improving pediatric adherence requires age-appropriate formulations, taste-masking, and swallowability strategies. Regulatory, clinical, and technological insights help overcome barriers and support safer, more effective therapies for children across developmental stages.

• Overcoming Challenges In Cell And Gene Therapy Containment

  Review the hurdles that can slow your time to market, including the challenges in packaging high-value therapies and solutions to help you mitigate risk and simplify the journey.

• Understanding Of Amorphous Solid Dispersions & Their Downstream Development

  Understanding the properties of ASDs and their relationship to the downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs.

• Partnering With Clinicians To Improve Pediatric Formulation Development

  Greater collaboration between formulation experts and clinical colleagues, including healthcare professionals, is advocated to lead to safe and effective, age-appropriate medicinal products.

• 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.

• 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.

• Lyophilization vs. Liquid Formation: Why Lyo Offers Advantages

  Lyophilization offers some alluring advantages in today’s complex market, but its challenges require innovation and expertise to surmount.