Industry Insights

  1. The 5 Pillars Of Clinical Trial Material Management 2/25/2020

    Ensuring that enough study drug supplies are available at study sites is a requirement of every clinical trial. This article discusses five fundamental tools and techniques for effective planning, execution, monitoring, and inventory control of clinical trial material from the manufacturing, packaging, and distribution perspectives.

  2. The Role Of The Contract Manufacturer Under The EU MDR & IVDR 5/31/2021

    As of May 26, 2021, medical device companies must now comply with the EU's Medical Device Regulation (MDR) requirements, and the In Vitro Diagnostics Regulation (IVDR) requirements are effective in May 2022. This article examines the role of the contract manufacturer under these regulations.

  3. How Can You Ensure Successful Late-Phase Development And Launch?

    It is important to consider several factors in the overall development approach during the early phases in order to de-risk the late-phase development of your biologic drug product.

  4. Clinical Study Conduct During The COVID-19 Pandemic — Challenges & Solutions 4/6/2020

    Life science companies across the world are scrambling to mitigate the impacts of COVID-19 on their clinical studies and business operations, and there are no clear-cut answers at this time, nor a one-size-fits-all solution. But what we do know is that we are all in this together and that this is another challenge that the biotech industry was built for.

  5. Optimization Of Transient Protein Expression In CHO Cells

    Discover a set of optimized transient expression tools to support early stage expression of a range of therapeutic proteins.

  6. How to Ensure Your Quality Culture Assures Data Integrity 4/14/2021

    One solution to ensuring data integrity is to automate the process, essentially removing the human element. But not all instances of data generation/capture can or should be automated. With humans – our team members – engaged in data generation/capture, the quality culture is a major pathway to assuring our data have integrity.

  7. How In-House CDMO Analytics Reduce Risk and Cost 10/21/2025

    Integrated analytical capabilities within a CDMO are increasingly preferred to overcome challenges associated with outsourcing analysis in biopharma development and manufacturing.

  8. Cell Culture Media Demystified For Performance, Quality, And Innovation 11/13/2025

    Cell culture media isn’t one-size-fits-all. Learn how media composition, customization, and analytics can dramatically improve cell growth, productivity, and product quality for complex processes.

  9. The Complex Regulatory Landscape Of Flow Cytometry For Cell Therapy 11/8/2024

    Flow experiments must be controlled to produce consistent data. With a gush of new technology, regulators have put more scrutiny on flow cytometry-based approaches.

  10. Are Annex 1's CCS Requirements Still Challenging You? 6/5/2024

    Contamination control strategies are nothing new, but their inclusion in the Annex 1 update represents one of the revision's few new requirements.