Insights On Outsourced Drug Development

1. Characterization Of A Novel Human Primary Intestinal Epithelial Monolayer Platform In Response To A Cytokine Challenge 8/6/2021

   The ability to grow and expand primary human epithelial cells in vitro has been a significant advancement in the field of gastrointestinal biology. 

2. Explore Alternative Analytical Methods To Solve Process Challenges 10/30/2019

   Successful and rapid analytical method development plays a key role in ensuring the development of robust processes to produce high-quality products. 

3. Integrated Tools For Upstream Process Intensification: Part II 10/27/2019

   Changes to bioprocessing methodologies in the biopharmaceutical industry are being driven by the need for increased speed, a lower cost of goods (COGs) and greater flexibility. Faster development times are required to progress biologics and vaccines more rapidly into clinical development and then to market to improve worldwide accessibility. Continue reading in part 2 of this series how in order for intensified and continuous bioprocessing to deliver on these quality and productivity promises, there is a requirement for intelligently designed products.

4. Analytical Services: Risk Management In PFS Components Selection For Sensitive Biological Drug Formulations 6/10/2021

   Choosing the right containers and materials is critical but difficult, and no methodology can quickly assess the risk of drug/device interaction. Two risk-based test methodologies help to select the optimum closure materials and the correct syringe silicone level at the early phase of drug development.

5. Applying Quality By Design To Pharmaceutical Research And Development 12/1/2020

   QbD is often discussed in the context of process development and manufacturing. We focus on QbD applied to R&D to drive better results throughout the drug development process.

6. Lonza & Me: Corvus 9/7/2021

   Corvus, a small biotech developing precision medicines, primarily for oncology patients, was seeking to develop a monoclonal antibody called CPI06, now known as Mupadolimab. This inhibits the production of adenosine in the tumor microenvironment and has an agonistic effect on B cells.

7. Effects Of Feeding Strategy On CHO Cell Performance In Fed-Batch Cultures 2/21/2020

   This app note demonstrates a fed-batch process for a CHO cell line producing a mAb. The results emphasize the importance of an appropriate feeding strategy to optimize cell growth and productivity.

8. Cell Line Development Toolbox For Intensified Bioprocessing 9/8/2021

   If intensified processes lead to productivity improvements, then the Cell Line Development Toolbox holds the answers to make intensified bioprocessing a reality. Learn more about these technologies to optimize clone selection, shorten seed trains, and speed up early process development.

9. Technology Selection To Enhance Bioavailability 7/23/2020

   Bioavailability challenges are among the toughest problems faced by today’s formulators. Most of the prospective drugs in pharmaceutical pipelines today have low solubility, which means the active therapeutic ingredients can’t be absorbed when patients take them orally. This paper gives an overview of obstacles to bioavailability and summarizes the Lonza technology selection process.

10. Accelerate Time To Market With An Electronic Lab Notebook 4/21/2021

    Research organizations are challenged as never before to conceive and develop innovative scientific solutions rapidly and efficiently. Technology has made immense amounts of research information available at a keystroke—information that can spark creativity and new collaboration opportunities. However, scientists recording, managing and archiving research data in paper lab notebooks cannot keep up with this data deluge. This white paper examines the challenges of managing research data today and what to look for in an ELN.