High-Volume Scanners

WHITE PAPERS AND CASE STUDIES

• How Community Oncologists View CAR T-Cell Therapy Possibilities And Challenges

  Learn how a partner with innovative solutions aimed at overcoming the barriers that limit the real-world impact of CAR T-cell therapy can make these advanced therapies more accessible and affordable.

• Streamlining Study Start-Up For Accelerated Drug Development

  What is the secret to safely expediting study start-ups? Explore our case study to find out how open dialogue, aligned expectations, and direct communication between Altasciences’ team leads and sponsor contributed to a clinical trial start-up of only 3.5 weeks.

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• Overcoming HCP Co-Elution Issues Using Cell Line Engineering

  Product quality assessments revealed that a customer’s therapeutic protein had a range of hydrophobic HCPs. Review a solution that took an alternative approach by utilizing cell line engineering.

• How To Manage Burgeoning Data Traffic On A Finite RF Spectrum

  Explore strategies and innovations to unlock higher-frequency bandwidths, which are crucial for sustaining technological advancement and meeting the escalating demands of our connected future.

• Suspension Culture Improves iPSC Expansion And Pluripotency Phenotype

  Learn about the advantages of 3D suspension culture for iPSC expansion, including enhanced pluripotency and genetic stability. Discover how this technique yields high-quality iPSCs for regenerative cell therapies.

• Building Local Biomanufacturing Capacity In South Africa

  Biovac evolved from a vaccine supplier to a biopharmaceutical innovator, providing a blueprint for expanding Africa's vaccine manufacturing capacity. Gain valuable insights from their journey.

• ProPharma Supports A Contract Manufacturer's Form 483 Response

  Learn how a small contract manufacturer navigated a complex FDA 483 Observation notice and implemented effective remediation strategies that addressed multiple system-wide concerns.

• Extractables And Leachables Assessment For Single-Use Systems

  Efforts to enhance biopharmaceutical manufacturing focus on boosting production capacity sustainably and economically. Explore how optimizing processes with single-use solutions and monitoring leachables ensures product quality.

• How To Get Products To Patients Faster With A Connected QMS

  BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

• Custom Mobile Pharmacy Cleanroom Trailer For Oncology Infusion Pharmacy Services

  Gain insight into the mobile cleanroom that was created to accommodate the needs of Moffitt Cancer Center's Oncology Infusion Pharmacy Services and adhere to USP <797> and <800> standards.

• Compliance Auditing: Diving Into Common Critical Findings

  Review critical findings in compliance audits, highlighting frequent issues, their impact on operations, and steps companies can take to improve regulatory compliance.