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WHITE PAPERS AND CASE STUDIES

• Solving Cost And Supply Challenges In Biopharma Downstream Processing

  In response to the growing demand for monoclonal antibodies, researchers are looking at different areas of the downstream process where they can improve efficiency and scalability.

• The Ripple Effect: A Digitalization Playbook

  As the water sector takes on the escalating challenges of accessibility, affordability, and resilience against climate change, digital solutions have demonstrated the potential to transform water systems.

• How Can The Industry Drive Down The Cost Of Viral Gene Therapies?

  This article discusses how a combination of optimizing your process development, and process intensification can help drive the cost of dose down.

• The Annual Clinical Trials Roundup

  Delve into in-depth analyses of key diseases, players, and geographies influencing the pharmaceutical industry through an overview of Phase 1–3 clinical trials initiated in 2022 across all therapeutic areas.

• Cell And Gene Therapy Field Quiet In Q2

  While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.

• How To Run Successful Clinical Trials In Japan

  Read about why there is no longer any excuse not to include Japan as an integral part of any global clinical-development program for either pharmaceuticals or medical devices. 

• Understanding Biosafety Levels

  Compliance with biosafety levels (BSLs) is crucial in ensuring that your laboratories meet stringent standards to protect staff and prevent the escape of biological agents.

• Building A Legacy In Sterile Injectables Through Strong CMO Synergy

  Examine how a CMO can deliver significant value to drug developers by fostering successful outsourcing relationships, streamlining the path to market, and supporting demands.

• The Future Is Now: CGT Innovation, Challenges, And Perspectives

  As CGTs advance toward clinical trials, developers face a number of challenges such as navigating a shifting regulatory landscape and employing beneficial manufacturing processes.

• The Evolution Of EAM/CMMS In Pharma Manufacturing

  Explore pharma’s shift from paper-based maintenance to modern EAM/CMMS that shows how digital tools boost compliance, reduce downtime, and improve data accuracy and productivity.

• The Role Of The Technical Transfer Executive Sponsor

  Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.

• MilliporeSigma's 97-Day Implementation Success Story

  Read how MilliporeSigma transformed validation processes with a digital validation system to achieve compliance in just 97 days, as well as learn key takeaways from their swift transition.