ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• How Nanoparticle Platforms Are Unlocking Genetic Medicine's Potential

  Explore how the HIT SCAN platform accelerates gene therapy delivery by screening polymeric nanoparticles, enhancing precision and regulatory pathways for next-generation genetic medicines.

• Application Of A Novel Temperature Shift Process For Particle Engineering

  Spray drying of amorphous dispersions improves solubility and bioavailability, enabling supersaturation in the intestine and driving higher absorption rates when compared to crystalline drug forms.

• Which Testing Does An Effective Certificate Of Analysis Include?

  Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.

• 3 Keys To Rare Disease Clinical, Commercial Drug Product Manufacturing

  The complex biology of rare diseases creates unique hurdles, making it difficult to design and implement a drug development program. Explore the unique considerations for drug product manufacturing.

• NovaPure Stoppers - The Right Choice For Oncology Drugs

  Vial containment systems with NovaPure® elastomer stoppers offer substantial performance benefits with their enhanced dimension control, reduced particle levels, inspection of every stopper, and use of FluroTec® film. Explore the performance of the film and why NovaPure stoppers should be the choice for sensitive drug products.

• The Importance Of Strategic Alliance Partners In Biopharmaceuticals

  Today’s drug delivery systems are complex technologies that require close teamwork between biopharmaceutical companies and their drug delivery technology partners to develop innovative platforms.

• How Recent Trends Impact Bringing Your Molecule To Market

  With accelerated approval times, growing competition between drugs, and a shift from hospital to home care, you’re under pressure to develop a delivery device in parallel with your drug.

• The Importance Of A Human Centered Approach To Product Development

  To meet the needs of patients, life-saving device innovations are needed for the next generation of delivery devices. As drug manufacturers explore the device world, human factors are a key consideration.

• Extractables And Leachables – Assessing Risk In A Complex Landscape

  It is not surprising that there is still confusion on the extractable and leachable topic. Guidances, where available, do not give step by step instructions on testing.

• Combining Gene Therapies, Carrier Systems, And Medical Devices

  Drug delivery is one of the most significant obstacles to advancing gene therapies. Examine the opportunities for success in combining novel medical devices to improve delivery of gene therapies.