CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Predicting Antibody-Dependent Cell-Mediated Cytotoxicity

  We developed and validated a dual screening procedure (genotype and phenotype) for Lonza human peripheral blood mononuclear cells (PBMCs) to identify donors with high ADCC potential.

• Automated NGS Solutions Advance Rare Disease Research

  See how a unified NGS workflow is helping a major pediatric genetics lab boost efficiency, manage growing sample volumes, and accelerate insights into rare diseases through streamlined automation.

• Innovating The mAb Characterization Process

  Understanding the characteristics of a molecule's "personality" is crucial for optimizing development and manufacturing. Learn how to overcome the challenges in the characterization process.

• FDA's Regenerative Medicine Advanced Therapy (RMAT) Program

  RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.

• Tailored Approach Supports Bladder Cancer Breakthrough

  Discover how a flexible operational strategy and expert site management help bladder cancer programs overcome complex logistical hurdles and achieve critical regulatory milestones.

• Expansion Of Human Bone Marrow-Derived MSCs

  Achieving over 870 million viable, quality mesenchymal stem/stromal cells is possible. This efficient cell culture method scales bone marrow-derived MSCs for clinical needs.

• Performance Of A Customizable DMSO-Free Cryopreservation Media Formulation

  Cryopreservation enables cell therapy by storing cells long-term. A DMSO-free formula preserves cell viability and health, minimizing toxicities linked with traditional cryoprotectants.

• Boosting CMC Regulatory Efficiency In Gene Therapy

  Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.

• Supporting Complex Manufacturing For Liquid And Lyophilized Drug Products

  Aseptic fill and finish operations gain efficiency and precision with modular isolator technology, inline weight checks, and lyophilization, which are ideal for mRNA-LNPs and other sensitive modalities.

• Streamline Analytical Tech Transfer Through Analytical Target Profile

  Analytics debt in CGT can derail timelines and budgets. Learn how early ATP planning and cross-functional alignment can eliminate costly setbacks and accelerate IND approvals.