Business Process Management

WHITE PAPERS AND CASE STUDIES

• Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays

  Receptor occupancy (RO) assays assess drug-target engagement and support PK/PD modeling. Accurate RO requires customized assays using stabilized blood to monitor CD6 modulation in autoimmune therapy.

• Flexible Fill/Finish Solutions To Bridge The Clinical-To-Commercial Gap

  As biopharma complexity grows, flexible CDMOs are essential for navigating evolving fill/finish needs, accelerated timelines, and regulatory uncertainty with agility and expertise.

• The Role Of Hexapods In High-Precision Machining

  A custom hexapod was introduced at ILA Berlin 2024, enhancing precision in aircraft construction. This 6-DOF system improves contour machining of CFRP components, reducing manufacturing times and costs.

• How Vanguard Clinical Harnesses CDMS/EDC For Faster Results

  Uncover how this CRO was able to stay agile by choosing a CDMS/EDC partner that prioritized sponsor needs and streamlined operations to achieve top-tier results swiftly.

• Improving Manufacturing Data Collection And Information Visibility

  A top global CDMO facing challenges with communicating manufacturing data and making informed decisions implemented a digital solution that improved data collection and information visibility.

• Is Sustainability The Key To Agile Biopharma Manufacturing?

  In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.

• Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer

  Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.

• Development Strategies For Adenovirus-Based Gene Therapies

  Scaling up viral vector production can be challenging, and ensuring consistent titers and activity requires careful optimization and technical expertise.

• 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.

• Enhancing Viral Clearance Prediction And Process Optimization

  MockV® technology enables early, in-house viral clearance assessment, helping biopharma developers improve process robustness, reduce costs, and enhance safety before GMP manufacturing begins.

• How A Top Biotech Achieved Right-First-Time Batches

  Gain insight into how a global leader in pharmaceutical manufacturing overcame significant challenges related to their ultrafiltration process.

• Overload Setting – Tricks And Techniques

  Learn how a partner company that is committed to assisting manufacturers with calibration and optimal set-point establishment can serve as a valuable resource in achieving optimal tablet production.