Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• How Dwell Volume And Extra-Column Volume Impact Method Transfer

  Understand how system factors like dwell volume and extra-column volume contribute to method performance across labs and how this knowledge can increase the success of method transfer.

• CDOX® And CO2-Based System Replaces Manual Chemical Dosing Of Strong-Acids, Increasing Workplace Safety

  The wastewater pre-treatment plant processes effluent from the manufacturing facility prior to discharging into the sanitary sewer system for treatment at the municipal wastewater facility. Use of sulphuric acid to manage the pH of the wastewater in the buffering reactor tank prior to entering the DAF for solids and oil removal was considered to be an unnecessary risk requiring significant safety protocols.

• Clinical Supply Optimization: Process Improvement Accelerates Trials

  A biopharmaceutical sponsor required the study start-up phase to be reduced to 91 days, involving comparator sourcing and blinding, kitting, packaging, labeling, and distribution to the sites.

• 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.

• Method Optimization: Assay Development Following Compendial Methods

  There was a short time frame of only 7 weeks to complete assay optimization and conduct pre-validation studies within the confines of USP<621>.

• The Potential Return On Investment Of Using ePROs Over Paper In Clinical Trials

  Industry perception is that the start-up costs of implementing an ePRO platform may dwarf the cost of printing and distributing paper diaries by as much as 10 times. However, this does not take into consideration the significant value and return on investment that adopting ePRO technology has had on overall clinical trial costs and timelines due to improvements in data quality and completeness, participant retention and compliance, and study and site efficiency.

• Reduce Time, Cost, And Risk With Clinical Study Data Review Software

  A Top 10 global biopharmaceutical company needed to implement a single clinical study data review system to reduce the time, cost, and risk of running their clinical trials while accelerating the time to market. The company deployed PerkinElmer's interactive data visualization and analysis solution to their clinicians and safety reviewers that is quickly becoming the tool of choice.

• 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.

• "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.

• Digitalizing Cell And Gene Therapy Manufacturing

  MES solutions can remove paper from the manufacturing floor once and for all — while boosting operational efficiency and saving costs.

• Monoclonal Antibody Manufacturing: Build Or Outsource?

  The standardization of biologics manufacturing processes has given product developers multiple viable options for producing monoclonal antibodies (mAbs), including building an in-house mAb production system or partnering with a contract biologics manufacturer.

• What Level Of Review Does Your Study Need?

  The level of IRB review required for research involving human subjects depends on the study’s specific design and the risks involved. Some research must be reviewed by the fully convened IRB, while others may be reviewed by a designated IRB member. Some projects may not even require IRB review. By applying the same four-step evaluation process used by IRB members, research professionals can better plan for a study’s necessary level of review and save time in study startup.