Bioprocessing White Papers

1. Risk Mitigation Strategies For Raw And Starting Materials Used In Gene Therapies 5/15/2020

   Recently approved cell and gene therapies are delivering impressive results for patients who otherwise have exhausted all treatment options or have had no options available to them. However manufacturers are faced with many challenges in the journey from development to commercialization. Within this challenging environment, a number of risk mitigation strategies related to the materials used to produce viral vectors can be employed to help accelerate progress towards commercialization of these remarkable therapeutics.

2. Seed Train Intensification Using High Cell Density Cryopreservation And Specially-Designed Expansion Medium 5/14/2020

   Strategies such as process intensification have the potential to create shorter lead times, reduce plant footprint, increase flexibility and reduce COGs. Upstream processes can be intensified using a number of strategies which can deliver significant improvements in speed, flexibility and reliability. In this whitepaper, we explore two of these approaches – High cell density cryopreservation (HCDC) and the use of a perfused seed train including a specially-designed expansion medium.

3. Reducing The Risk During Cell And Gene Therapy Development And Manufacturing 5/13/2020

   While these new modalities are generating significant excitement among patients and caregivers, cell and gene therapy manufacturers are experiencing growing pains. The rapid growth and continued momentum of the industry has led to the issuance of new guidance. In this article we share insights for navigating within a novel and complex regulatory environment, mitigating risks posed by raw materials and implementing proper risk assessments during manufacturing.

4. Beyond COVID-19: Localization Can Strengthen Supply Chains 5/8/2020

   The coronavirus pandemic has already changed the way industry looks at localization and forming resilient supply chain capabilities. In the current climate, not having local capabilities could shutter your business.

5. Robust Business Continuity Program Helps To Maintain Operations In The Face Of Crisis 5/5/2020

   Experts at Cytiva provide insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.

6. Telltale Signs You’re With The Wrong CDMO 4/27/2020

   Is your CDMO an asset or a hindrance? This article explores 10 red flags that signal your parter isn't carrying its weight on your journey to commercialization.

7. From Research To Commercial: A Seamless Supply Of Oligonucleotides 4/24/2020

   This white paper discusses how to meet the seamless supply challenge by providing development, scale-up and synthesis capabilities of research to commercial quantities of customized oligonucleotides.

8. How Buffer pH And NaCl Affect Size Exclusion Chromatography 4/22/2020

   Using a design of experiments approach, this study describes the effect of buffer pH and NaCl concentration on proteins purified by size exclusion chromatography.

9. Challenges In Bulk Drug Substance Logistics – Overcoming The Hurdles 4/15/2020

   Freezing of biotherapeutics is a common unit operation, primarily used to extend the shelf life of the drug substance and provide flexibility in production and logistics. While technically simple to perform, the freeze-storage-thaw cycle comprises several mechanistic aspects that can compromise protein quality if not properly understood and addressed.

10. Bulk Drug Substance Logistics – Primary Packaging 4/15/2020

    There are currently many options of primary packages on how to transport the drug substance from A to B. This paper explains the benefits and shortcomings of a few of those options.