Application Notes & Case Studies

1. Upstream Platform For Continuous Lentiviral Vector Production 12/1/2020

   Process scalability, lot-to-lot consistency, and the cost and supply of high-quality plasmid are some of the constraints that have made manufacturing of LVs challenging. Here, we demonstrate a high-yield LV production process, using animal-derived component-free (ADCF) media and reagents, where multiple or continuous vector harvests could be obtained from a single batch.

2. Industrialization And Scale-Up Of Drug Delivery System 11/30/2020

   A pharmaceutical company and their product design partner were in need of a contract manufacturer capable of supporting the device development, injection molding, tooling, supply chain logistics and scale up automation strategy. The customer had developed a novel breath actuated pulmonary device and they were looking for the right manufacturer to assist them with product development refinement, samples for clinical trials and ultimately commercialization.

3. How a Best-Practice Strategy For Sourcing Ancillary Materials Reduced Risk, Spending and Workload In A Global Diabetes Trial 10/29/2020

   It’s impossible to run a global clinical trial of an investigational diabetes drug without ancillary materials. And as one leading multi-national pharmaceutical company recently learned, managing ancillaries can be a challenge every bit as complex as the trial itself.

4. Moisture Headspace Analysis For Efficient Scaleup Of Freeze Drying Capacity And Validation 10/21/2020

   A vaccine production facility needed to replace an old freeze dryer in an existing facility during running operations. Activity involved a scale up of freeze-drying capacity from 14 m2 to 28 m2. With the application of non-destructive feadspace moisture analysis small scale proof of concept studies were used to minimize project risk and the number of full-scale runs in the freeze-drying validation process.

5. Delivering Clinical Trial Medications Direct-To-Patient 10/15/2020

   In a perfect world patients enrolled in clinical trials would live a short distance from the investigator site where they receive their treatment. Unfortunately that is not always the case. In recent years the Direct-to- Patient model, which brings medical procedures to a patient’s home, has emerged as a solution for Sponsors to increase patient recruitment and retention in clinical trials.

6. Electronic Lab Notebooks - Implementing Next-Generation Laboratory Informatics 10/11/2020

   Electronic Lab Notebooks are a key component of an electronic lab environment that helps scientists execute faster, more informed, high-quality science. It’s a vision scientists have talked about for decades.

7. How Intelligent Collaboration Transformed A Generic Into A Best-In-Class New Drug 10/7/2020

   A pharmaceutical developer specializing in leveraging common compounds for new indications needed to transform a generic solid active pharmaceutical ingredient (API) into a commercial, sterile injectable approved by regulators. Read how collaboration and the drive to find a workable solution led to a successful drug development program.

8. Particle Engineering For Inhalation Drug Delivery 10/6/2020

   Inhalation-based drug products play a critical role in addressing the rising incidence of respiratory diseases around the globe. Particle engineered-based formulations are key in designing and developing effective dry powder inhaler (DPI)-based drugs. This article discusses key parameters for choosing the right particle engineering approach to meet DPI target product profiles.

9. Engineering Approaches To Respiratory Drug Delivery: Mannitol Case Study 10/6/2020

   Spray drying and jet milling are commercially viable engineering processes for the development of respirable drug products. This article presents a case study that explores the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol. Read our article to learn more.

10. Seamless Operational Data Migration: A Genentech Story 10/1/2020

    Genentech’s transition of 20+ years’ worth of data from a legacy historian to OSIsoft’s PI Historian resulted in greater system stability and improved user access.