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

1. Considerations For Upstream Biologic Development 11/12/2019

   A biologic candidate's path from DNA to drug-in-vial is long and complex. These considerations might simplify and improve the economics of the process, helping molecules get to market as quickly as possible.

2. Fast And Efficient Workflow To Monitor CRISPR-Cas9 Gene Editing Of Haploid Cell Lines 3/15/2020

   CRISPR's speed, low cost, and ability to be used in many model systems redefine what is possible in drug discovery and development. However, current workflows  for generating knockout cell lines using CRISPR-Cas9 can be complex and inefficient. In this study, we demonstrate a novel workflow that includes Droplet Digital™ PCR, high resolution melt analysis, western blotting, and real-time PCR to generate and validate a knockout haploid cell line in less than five weeks.

3. Getting Creative: A Hybrid Answer When The Conventional Won’t Do 3/2/2020

   A small oncology-focused biotech company presented such a challenge when seeking to contract out its data management services. This CRO combined outsourcing, insourcing, and geographic flexibility to devise a hybrid solution.

4. Considerations For Your First Clinical Trial 9/15/2020

   It's important to understand that CROs do not typically manage the comprehensive clinical trial supply chain. This paper reviews seven ‘clinical trial supply best practices’ to help ensure a successful trial.

5. Comparing Continuous And Batch Processing In Downstream Purification 6/10/2019

   Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.

6. Keys To Successful Risk Management In Clinical Trials 1/5/2021

   Effective risk management recognizes variables unique to each clinical trial while embracing consistent documentation practices, stakeholder responsibility, and best practices informed by experience.

7. An End-To-End, Semi-Continuous Process For mAb Production 9/22/2019

   See how the different unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected and integrated into a semi-continuous process.

8. EDGE Confocal Imaging Technology 10/9/2019

   Increasingly, scientists are being challenged to study more biologically-relevant model systems, and this often means imaging thick, demanding 3D samples that may also be alive. Read how IRIS and EDGE confocal imaging can offer high contrast imaging of thicker samples.

9. 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. 

10. The Value Of Reliability Assessments And Benchmarketing In Life Sciences 12/21/2020

    A global medical device manufacturer sought to improve Safety, Equipment Reliability, Overall Equipment Effectiveness (OEE), and cGMP regulatory compliance by performing a plant-wide reliability and best-practice benchmarking assessment. The goal: perform a thorough reliability assessment and benchmarking against industry standards, OSHA, and cGMP requirements to establish a reliability roadmap for moving the organization into regulatory compliance and industry best practice performance