Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Markers And Methods To Verify Mesenchymal Stem Cell Identity, Potency, And Quality

  This white paper defines and discusses the evolution of MSC nomenclature and provides a detailed description of MSC markers and how they may vary by tissue source and species. Learn how to standardize MSC characterization by selecting markers for isolation, characterization, and validation.

• CCI Test Method Validation For Pre-Filled Syringes

  Regulators are paying closer attention to the proper design of robust Container Closure Integrity (CCI) studies and the validation of CCI test methods. 

• Considerations For Improving Outcomes In Biopharmaceutical Process Development

  In this article, we take a look at how the biopharmaceutical process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods.

• "Ultra High” Potency Development And Manufacture

  A biotech with limited experience in the development and manufacture of high potency compounds sought to develop a process for producing a highly potent API used to treat an unmet oncology need.

• Validating Targets For Targeted Protein Degradation Using dTAG – A Comprehensive Workflow Solution

  Degraders and the field of Targeted Protein Degradation offer a mechanistically differentiated way to modulate target proteins using small molecules. TAG degradation technology offers a generalizable strategy to degrade, in principle, any intracellular protein of interest (POI). In this paper we present data to highlight a full dTAG workflow solution, from custom KI cell lines for a protein of interest, to different dTAG Degraders available for treatment and subsequent quantitative characterization using an automated high throughput western blotting platform, Simple Western.

• Ethical And Biosafety Oversight Of Gene Transfer Clinical Research: What Sponsors And CROs Need To Know

  This paper focuses on important points to consider when planning to initiate clinical trials with these products at sites inside or outside the USA, if the research is subject to rules and regulations of the FDA and/or the National Institutes of Health (NIH) of the United States.

• Navigating Regulatory And Development Milestones In Biopharma

  This article addresses how early-stage biotherapeutic companies can avoid common pitfalls as they navigate the funding and regulatory processes to bring novel therapeutics from research to market.

• Radar Waveforms For Aerospace and Defense, Automotive Radar

  This white paper reviews radar waveforms for Aerospace and Defense and commercial radar systems, as well as commercial radar sensors like those used in automotive safety applications. Pulse and pulse-Doppler signal, continuous wave, and frequency shift keying waveforms are described.

• Strengthening Trial Enrollment Through Pre-screening

  A top-10 pharmaceutical company wanted to quickly enroll patients into four separate clinical trials, two dealing with organ transplantation and two focused on gastrointestinal disease. The sponsor agreed that pre-screening via paper or Excel spreadsheet would be time consuming, inconsistent, and create delays in information submission. Find out which solution was selected.

• Small Molecule APIs: Aligning Drug Strategy With Partnering Strategy

  Development of novel small molecule APIs is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy. 

• Liqui-Flux Case Study: Large-Scale Treatment Of River Water For Industrial Use

  Ultrafiltration (UF) is commonly used as a pre-treatment to Reverse Osmosis (RO) to ensure reliable, consistent and efficient operation. As Shandong Hongxin Chemicals Co., Ltd in China recently discovered, this consistency and reliability, along with quick setup and installation times, helped them realize convenience and cost savings.

• Large Research Healthcare System Maintains Compliance Through Internal Program Assessment

  Explore how a clinical research operations assessment was conducted to ensure compliance and maintain critical funding sources.