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

31. Factoring The “What Ifs” Into Supply Forecasting 8/24/2020

    Growing urgency in the biopharmaceutical industry to speed new products to market is leading to greater appreciation for supply forecasting as a strategic and highly complex success factor. This paper discusses the aspects to consider when developing a supply plan, the influence of early decisions and impact on outcome as a trial progresses, and how decisions can put patients and the trial at risk.

32. Sterilizing Grade Filtration Unit Operations For Plasmid DNA Processes 11/19/2020

    The large size of pDNA can present a challenge for sterile filtration unit operations within your gene therapy manufacturing since the product can be retained by the filters, leading to both yield loss and low filtration capacity. Optimization of a sterilized grade filtration unit can help increase yield and filtration capacity. Read on to learn more!

33. QbD For Process Development, Scale-Up Of A Novel ALS Drug Product 8/4/2020

    Thermo Fisher’s stepwise approach to Quality by Design (QbD), an approach that drives consistent quality into manufacturing, became integral to the success of Amylyx's AMX-0035 campaign. 

34. Reducing Cost Within Advanced Therapy Clinical Trials 4/10/2019

    The challenge for advanced therapy companies is that they need to develop a supply chain that delivers their therapy, at scale, without adding significantly to the cost of goods sold (COGS). In this case study, you'll learn how a company saw 55% cost savings across its distribution system and increased visibility of its supply chain through utilizing a Total Transportation Management (TTM) system.

35. Key Considerations For Laboratory Facility Design Planning And Optimization 11/6/2020

    Laboratories are an integral part of the pharmaceutical industry. They are used at each stage of the product development. See how this solution allows you to plan projects without having to build new labs and gain the ability to plan projects better, inventory management, being nimble in responding to demand fluctuations, avoidance of under and/or over utilization of talent and reliable capital project planning that is based on actual utilization tracking.

36. Commercial Scale Manufacturing of Allogeneic Cell Therapy 11/26/2019

    Allogeneic cell therapy products are generating encouraging clinical and pre-clinical results. Many of these therapies are also expected to have large market sizes and require cell doses of ≥10⁹ cells. As therapeutic technologies mature, it is essential for the cell manufacturing industry to keep pace to adequately support commercial scale production. To that end, there is much that can be learned and adapted from traditional manufacturing fields. In this review, we highlight key areas of allogeneic cell therapy manufacturing, identify current gaps, and discuss strategies for integrating new solutions.

37. Particle Size Analysis Overview 8/31/2020

    This paper reviews different analytical techniques for particle size analysis, including types of distributions, laboratory versus online systems, and sample result comparisons. It is intended to help those new to particle size analysis understand each technique’s various strengths and weaknesses in order to select the proper technique for their samples.

38. CAR-T Cell Therapies: Safety Considerations and Toxicity Management 1/9/2019

    Along with demonstrated efficacy in hematologic malignancies, CAR-T cells have the capacity to elicit serious toxicities. Safety considerations related to CAR-T cells may impact both trial design and trial management, as the adverse events (AEs) associated with immuno-oncology agents differ from those associated with cytotoxic therapies. Learn how to make anticipating, preventing and managing toxicity a key component of clinical studies involving CAR-T cells.

39. Lessons Learned When Implementing A Risk Management Program 10/14/2020

    The design and implementation of risk management programs can be challenging. This white paper uncovers key lessons learned from our experience with over 120 RiskMAPs and REMS programs - which spans various therapeutic areas and targeted risks.

40. Validating The Stability And Durability Of Labels After Thawing From Cryogenic Temperatures 2/26/2019

    One important element of working in cryogenic temperatures involves ensuring labels remain intact and securely adhered to packaging after application as product moves from ambient temperatures to cryogenic temperatures to thawing at the point of use. The following study serves as a model for the need to validate label stability and adherence and is an example of the many different types of validation studies we regularly conduct to mitigate risk for customers during all phases of an advanced therapy clinical trial.