ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• From Innovator To Partners In Cell Therapy: Our Evolution Into A CDMO

  Explore the common pitfalls encountered in CGT CDMO collaborations, including communication breakdowns, differing regulatory interpretations, and program prioritization challenges.

• 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.

• How Subcutaneous Delivery Can Help Patients Manage Chronic Conditions

  Read more about how to improve your patients’ outcomes, avoid costly delays to launch, and provide a better return on investment.

• Solid Form Strategies For Increasing Oral Bioavailability

  Optimizing a drug’s solid form can improve its solubility and bioavailability when further molecular modifications are prohibitive.

• Analyzing Product Formulation Using Raman Microscopy

  Raman spectroscopy is used to compare the dissolution rates and pellet fine structure of branded Sporanox® with three similar generic products marketed across the world, all containing the same API.

• 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.

• 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.

• The Paradigm Shift: From Scale-Up To Scale-Out In Genetic Medicine

  The shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.

• Accelerating The Development Of Oncology Medicines

  Oncology drug development has seen a significant shift in focus, as molecule chemistries and drug technologies have improved. Explore five areas for consideration and the potential emerging solutions.

• The Role Of Micronization In The Journey To Drug Product Development

  Micronization is an incredibly important step of the process of transitioning a compound from initial discovery into the clinic. Learn more about the key benefits of micronization.