ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Investigational Medicinal Products: Labeling Changes And Their Implications

  Learn about Annex VI, which covers changes in the labeling requirements for investigational medicinal products (IMPs) and harmonizes them throughout EU countries.

• Prepping For Commercialization Through Supply Chain Logistics

  While cell and gene therapies are bringing new hope to patients experiencing rare and serious diseases, uncover how they're disrupting the biopharma market in new and challenging ways.

• Building Clinical Supply Agility In A Changing Trial Landscape

  Rising trial complexity demands agile supply built on integrated operations, solid planning, and fast issue resolution. Lean teams gain from partners providing flexibility, control, and global reach.

• Why Advanced cGMP Manufacturing Is Key to Pharma Success

  Advanced cGMP facilities deliver control, expertise, and reliable processes that protect quality and support smooth progress to market. Strong partnerships help reduce risk in complex programs.

• Clinical Manufacturing: What It Is And How It Works

  Clinical manufacturing is a specialized form of pharmaceutical manufacturing focused on producing drugs for clinical research. How does it work and how is it different from commercial manufacturing?

• A Custom IRT System Facilitates Precision Medicine Studies

  As the industry continues to embrace personalized medicine, the ability to implement and support an atypical supply chain is crucial.

• Key Considerations For Labeling Your Cell Or Gene Therapy

  As sponsors focus on maintaining the temperature range required for cell and gene therapies, they must also keep in mind the challenges this task presents when properly labeling them for clinical trial distribution.

• Powering Complex Personalized Medicine Oncology Trial

  Managing custom therapies requires a synchronized supply chain. Learn how to bridge the gap between manufacturing and clinical workflows to ensure seamless patient care in complex oncology trials.

• Cryobag Container Development For Cell & Gene Therapies

  ISR Reports addresses the logistical challenges faced by developers of cell and gene therapies regarding cold chain and cryopreservation.

• Sponsor Overcomes Hold And Steers Products Through Development

  Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.