ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Four Challenges That Stall Advanced Therapy Development

  Many challenges can stall an advanced therapy’s development, and the vast majority of them are tied to inadequate preclinical planning and partner vetting. Find how to foster a better development strategy.

• Opioid Reformulation Filed As A CMC Supplement In Less Than A Year

  Some reformulation projects are more challenging than others. See how innovative processing equipment from Freund-Vector was leveraged to develop an efficient and effective solution.

• Utilizing Robotic Aseptic Filling Systems To Meet Industry Needs

  An aseptic filling and closing machine solution allowed Catalent to reliably process a wide range of both trayed and nested vials for their client product needs.

• The Algorithm Is In: 5 Ways AI Is Transforming Medicine

  AI is transforming the medical field, offering innovative solutions to complex problems. Explore the potential of AI in revolutionizing healthcare and leveraging data to improve patient experiences.

• Formulation Research Strategy For Discovery- Stage New Drug Candidates

  Early stage formulation studies, which should support the emerging target product profile, will often yield important experimental results to aid subsequent development of clinically relevant dosage forms.

• Unlocking New Possibilities For Treating Rare Genetic Diseases

  With over 7,000 rare diseases, the potential for nanomedicine to revolutionize treatment is immense. While polymer nanoparticles hold great promise, several challenges remain.

• An Insoluble Problem? Oral Drug Solubility With Functional Polymers

  Review the basics of solubility enhancement and the formulation and manufacture of products that enhance solubility and common questions on the topic.

• Improving Toxicology Testing For Inhalation Products

  By embracing new approach methods, regulatory agencies can revolutionize toxicology testing. These methods can be adapted for various medications, including inhalers and nasal-administered drugs.

• Is The Autoinjector Dead? The Future Of Patient-Centered Drug Delivery

  Autoinjectors revolutionized drug delivery, but innovation is shifting toward oral, wearable, and alternative platforms. Future focus emphasizes patient experience, sustainability, and broader drug delivery toolkits beyond the autoinjector.

• From Regulators To PUPSIT: Notes On Annex 1 Revision Implementation

  Kevin Smyth, a biochemical engineer with 30 years of experience in the pharmaceutical industry, offers insights and expertise in working with firms to understand what regulators seek to meet new standards.