Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• Process Scale Column Packing Instructions

  Explore a comprehensive guide to using DurA Cycle A50, a high-capacity, alkaline stable protein A affinity chromatography resin for the downstream processing of mAbs and recombinant proteins.

• RNA: The Next Era In Therapeutic Development

  Review the unique set of challenges for RNA production that must be considered and solved to reach their full therapeutic potential.

• Supporting A Company In Manufacturing The RSM For Treating A Rare Tumour

  A clinical-stage oncology company needed a partner to manufacture the RSM. Examine how an optimized RSM manufacturing process helped deliver safe, effective treatment on an accelerated timeline.

• Navigating The Complexities Of CGTs With Regulatory And CMC Expertise

  Review the submission process and CMC expertise which helped a biopharmaceutical company targeting a rare-disease tumor type avoid a clinical hold and advance to phase 1 clinical trials.

• Top Therapeutic Areas In The Asia Pacific Clinical Trial Landscape

  Explore why the Asia-Pacific region has emerged as a clinical trial hub due to the ease of regulatory compliance, low trial costs, rising patient population, and the availability of top clinical institutions as trial locations

• 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.

• Response To FDA Black Box Warning

  The FDA has launched an investigation into the risk of T-cell malignancies following CAR-T cell immunotherapies. Review the key points of this announcement concerning the CGT research community.

• Choose How You Want To Pay: Flexibility In The Payment Process

  As the payment method landscape continues to evolve, retailers should have a strategy that takes into account current preferences and – to the extent possible – anticipates future changes.

• Performance Of Protein A Resins For Different mAbs

  Review a Protein A resin solution assisting biotech companies who are working with and removing impurities from a wide variety of antibodies.

• Rescuing A Global Full-Service Phase III Trial For A Late-Stage Oncology Biotech

  This case underscores the expertise employed in a comprehensive strategy and set of services that were used to salvage a Phase III clinical trial for ovarian cancer and ensure its timely completion.

• How eSource Reduced Benchmark's Protocol Deviations By Almost 40%

  Explore how a leading vaccine site network selected CRIO to help address the challenges with it's use of paper charts in collecting source data.