Harvest & Collection

WHITE PAPERS AND CASE STUDIES

• Feasibility Insights In HR+/HER2 - Metastatic Breast Cancer

  This case study showcases how advanced analytics were used to streamline feasibility planning for a Phase II clinical trial targeting HR+/HER2- metastatic breast cancer as a second-line treatment.

• Using eConsent Data To Populate Site And Sponsor Data Systems

  A top-10 pharmaceutical company was looking to reduce the amount of administrative burden on their clinical trial sites and themselves. See how we accomplished it, using eConsent.

• Digitalizing Batch Records In Pharmaceutical Production

  Pharma manufacturing embraces cutting-edge automation, yet outdated paper-based documentation hinders efficiency and delays batch releases. See how digital solutions can transform compliance.

• AMERICAN Plays A Role In Rebuilding Puerto Rico's Infrastructure

  AMERICAN is helping rebuild Puerto Rico’s vital water infrastructure after Hurricane Maria, supplying American-made products to strengthen resiliency for 3.5 million residents and millions of annual visitors.

• Large-Scale Exosome Production Stirred-Tank Bioreactors

  Discover how engineered exosomes, displaying tumor-homing peptides, offer a promising tool for targeted cytotoxic drug delivery, produced efficiently with a bioreactor for critical research.

• A Streamlined Biopharmaceutical Isolator Solution

  This custom-designed, eight-foot isolator helped a client meet their decontamination needs, maintaining ISO-5 sterile conditions while decreasing turn-around time for filling small batches.

• Expand Bandwidth With A Trusted Regulatory Writing Partner

  Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.

• Enhancing Site Capacity For Clinical Trials With DCT Nurses

  See how the rapid deployment of trained mobile nurses was able to mitigate resource-related obstacles and facilitate timely patient enrollment for a pediatric rare disease trial.

• Accelerate European Market Access With MAA Submission

  Discover how ensuring preparedness for Marketing Authorization Application (MAA) approval can streamline your application process and subsequent follow-up.

• Controlled Production Of MSC-Derived EVs In Stirred-Tank Bioreactors

  Learn how stirred-tank bioreactors overcome the scalability limitations of static culture for MSC-EV production, while Raman spectroscopy provides unprecedented real-time quality monitoring during production.

• Case Study: Full Clonality Assessment Of CHO Cell Line

  In this case study, a comprehensive genetic analysis was performed on a transgenic Chinese hamster ovary (CHO) master cell bank to characterize the bank and provide high-confidence evidence of clonality.

• How Can You Avoid Bioprocessing Risks When Using Cable Ties?

  Cable ties in bioprocessing can cause leaks, damage, and delays. See how switching to a uniform-sealing connector can significantly improve efficiency, reduce prep time, and minimize contamination risks.