Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• FDA Recommendations For Gene Therapy For PMDs

  Explore insight into the strategies and FDA recommendations for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).

• The State Of Global Clinical Trial Disclosure

  See what industry organizations are saying about trial transparency, regulations by region, what penalties are on the books, and whether they are enforced.

• Fortrea Optimizes Site Matching On Retina Clinical Trials

  Faced with challenges in engaging clinical trial sites within the retina research landscape, Fortrea sought a partnership that leverages RWD to streamline site feasibility assessments.

• Biotechnology Manufacturing Program Management

  Find out how a global biotechnology manufacturing company executing several interrelated projects achieved critical project objectives while adhering to schedule and financial commitments.

• Selecting A New Sporicidal Disinfectant: What The Cleanroom Manager Needs To Know

  This guide helps cleanroom managers evaluate sporicides by efficacy, safety, and compatibility to ensure contamination control without compromising operational integrity.

• Stopper Migration In Frozen Pre-Filled Syringes

  Review a semi-automated method for dynamically assessing plunger migration under controlled variations in temperature and pressure, utilizing computer vision tools.

• PEG In LNP Formulations: Addressing Challenges And Seeking Solutions

  Polyethylene glycol and similar variants have driven innovative research for therapies. However, the continued use of PEG poses significant drawbacks.

• De-Risking Preclinical Candidates With Predictive Immunotoxicology

  From target engagement and mechanism of action to efficacy and prediction of adverse immune reactions, immunology assays deliver data that reduce your risk of failing later.

• Development Of A Non-Standard Protein Therapeutic

  Discover how a tailored development approach transformed a complex therapeutic protein into a candidate ready for early-stage clinical trials.

• CDMO Accelerates Contract Manufacturing With Electronic Batch Records

  A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.

• Gateways To Asia: Market Access In Japan And South Korea

  Learn how the recent developments in market access and regulatory rules in Japan and South Korea have paved the way for expansion in Asia.

• Six Strategies For Accelerating Approval For Cell And Gene Therapies

  As you advance through the evolving regulatory landscape for cell and gene therapies, review these six proven strategies to help sponsors reduce their risk of failure and expedite speed to market.