Business Process Management

WHITE PAPERS AND CASE STUDIES

• 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.

• Simplify CAPA In 7 Steps

  Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

• Material Selection For Medical Device Manufacturability

  Choosing the right material in the earliest stages of research & development can make all the difference in beating your competitors to market and avoid increased project costs, development delays and manufacturing setbacks.

• How A Pharma Company Improved Yield By 1.5% In Just Three Months

  A pharma company faced a 4% yield drop and variability at a manufacturing facility. Explore how they leveraged an AI-based platform to unify data, pinpoint inefficiencies, and enhance consistency in yields.

• Digital Transformation - The Power Of Your Data

  Discover how you can circumvent numerous recirculations during the ultrafiltration process step, boost downstream bioprocess yield, and identify and resolve process inefficiencies.

• Digital Transformation And Quality By Design For Enhanced Development

  Discover how digital transformation and Quality by Design are revolutionizing pharmaceutical development to boost efficiency, enhance compliance, and accelerate innovation across the drug lifecycle.

• Oligonucleotide Synthesis: Scale-Up Made Simple

  Scaling oligonucleotide synthesis isn't as straightforward as it seems. Explore key challenges, critical process parameters, and solutions for a smooth scale-up.

• GSK And Medable Discuss The Next Phase Of DCTs

  GSK and Medable share the value of embedding DCTs into strategic goals to enhance trial accessibility, diversity, and efficiency.

• Developing Effective Procedures

  Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

• From Regulators To PUPSIT: Notes On Annex 1 Revision Implementation

  Kevin Smyth, a biochemical engineer with 30 years of experience in the pharmaceutical industry, offers insights and expertise in working with firms to understand what regulators seek to meet new standards.

• Establishing Analytical Methods For mRNA-Based Therapies

  Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.

• Driving Customer Profitability With Enterprise Platform, Pricing

  Explore how the solutions and approaches offered by CDS can help different research stakeholders conduct more cost-efficient clinical trials in the industry's pharmaceutical, biotech, and device sectors.