Biosimilar App Notes & Case Studies

1. Developing A Closed Connected Single Use mAb Purification Process 9/28/2020

   This article provides an overview of a successfully designed closed and physically connected mAb process at the pilot scale with single-use components.

2. Automated High Throughput mAb Purification Using Fibro Technology 4/21/2020

   Read how the Fibro PrismA unit provides a time advantage with comparable recovery and product quality attributes to resin-based column.

3. 6 Reasons You Don’t Use Pharmaceutical Market Research 2/28/2020

   If you're using one of these six excuses for ignoring pharma market research, you're failing to understand barriers to success, missing the market’s perspective, and leaving assumptions unvalidated.

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

   Learn how a drug developer collaborated to transform a generic solid active pharmaceutical ingredient (API) into a commercial, sterile injectable approved by regulators.

5. End-To-End Process For Oncolytic Adenovirus Production 3/20/2019

   Oncolytic viruses constitute a new promising therapeutic approach for treatment of cancer. Here’s an example of a scalable, end-to-end process for oncolytic adenovirus production using modern tools and technologies.

6. A Model To Increase Yield In mAb Cell Culture Perfusion At Large Scale 9/28/2020

   As process intensification is adopted into large scale manufacturing, the responsibility of scale-down models to accurately represent the expanded operating space quickly follows. 

7. Cell Therapy Manufacturing Under GMP - How And When To Get Started 5/2/2019

   Emerging cellular therapies aim to manufacture cell populations for clinical indications, such as cancer, autoimmune, and cardiovascular diseases. As hospitals and translational facilities explore implementation of this technology they concurrently evaluate whether or not to manufacture the therapies onsite. Here is a guideline of how and when to get started.

8. Improving Lentiviral Vector Downstream Processing Workflows 8/5/2020

   Lentiviral vectors (LVV) are a common vehicle to deliver genetic material in CAR T cell therapy and gene therapy applications. Production methods have been developed by adapting technologies from the bioprocessing sector. However, these downstream workflows are long, require substantial manual labor, and suffer from low yields of infectious virus. In this article we discuss process development pain points of a modern workflow and ways to address them.

9. Low-Risk Approach For Process Transfer From Development To Manufacturing 8/17/2020

   This paper explores one approach for overcoming several scale-up issues with the use of miniature bioreactors for process development.

10. Pluripotent Stem Cell Expansion And Scale-Up 8/5/2020

    Upstream process development is complex for stem cell therapies, because these therapies involve many manipulations during cell differentiation or even cell engineering. Decisions made early in research will impact the entire product life cycle, so it is important to consider a good process design early on.