Cell And Gene Articles, App Notes, Case Studies, & White Papers

1. AVROBIO’s Geoff MacKay On Cell & Gene Scalability 10/4/2021

   Geoff MacKay, president and CEO of AVROBIO, talks with The Business of Biotech podcast about the scale up obstacles facing the cell and gene therapy space and how AVRO is working to tackle them.

2. Quantifying AAV Aggregation And Quality Attributes By FFF-MALS 2/2/2022

   This application note demonstrates how both SEC-MALS and FFF-MALS may be performed with a single set of detectors, providing valuable orthogonal characterization of these gene therapy products.

3. How STUDIUS™ Is Changing Cell Line Development 1/20/2022

   Methodologies, utilized in CLD, include viable cell counting, confluency, single cell seeding, plate transfer and consolidation, titer assays and microscopy. It is central to this narrative that data from all these aspects are joined together in a single story of a cell’s journey through this process.

4. Continuing The Conversation: The Future Of Reimbursement For Cell And Gene Therapies 8/26/2021

   Cell and gene therapies were expected to pose significant payer challenges however, several high-cost cell and gene therapies have achieved rapid and broad reimbursement to date across major payer bodies.

5. How Medable Increased Oncology Safety Monitoring By 90x 9/14/2022

   Oncology trials placed a heavy burden on patients due to travel burden, poor patient experience and multi-year clinical trial commitments. Sites also struggle with cancer trials due to enrollment delays, complex data workflows, and multiple amendments requiring re-consents. Today, there is a more effective, patient-first solution.

6. Implementation Of Rapid Test Methods In Cell And Gene Therapy Testing 10/12/2021

   Rapid testing methods for sterility, mycoplasma, and replication competent lentivirus of cell and gene therapies can help address critical issues within this rapidly growing area of the market.

7. Improve Product Quality As Early As Clone Selection 8/19/2021

   Product aggregation is a major stability, efficacy, and safety concern in the manufacturing of antibody therapeutics. This assay enables detection of product aggregates within days of single cell cloning.

8. Ensuring Provider Education And Readiness For Using A Novel CAR T 3/11/2021

   A client was launching a novel CAR T-cell therapy in rare hematologic malignancy and needed support to mount an effective launch by mapping the patient journey in this complex CAR T-cell therapy process, identifying the pain points for access to therapy and addressing the educational needs across stakeholders. We were able assist them with a successful launch by designing and implementing comprehensive site training and resources to ensure safe use and patient access.

9. Preparing For Future Viral Vector Manufacturing Technologies And Platforms 3/1/2021

   Rethinking how we transition from translational clinical centers at smaller scale—using flasks and open systems—towards commercial production and methodologies.

10. High Concentration Monoclonal Antibody Drugs Manufacturing Challenges 7/18/2022

    A review of high-conentration mAb manufacturing challenges including viscosity, aggregation, instability, and the effect of excipients on formulation, filtration, and fill and finish and bioavailability.