Business Process Management

WHITE PAPERS AND CASE STUDIES

• 3 Ways To Address Sterility Assurance Requirements Of The EU GMP Annex 1

  Learn about the three key proactive steps companies need to take to meet the sterility assurance requirements of the EU GMP Annex 1 for the manufacture of sterile medicinal products.

• An Experienced CDMO Can Be A Differentiator In The Rapidly Growing Biologics Market

  Discover how an experienced CDMO offering a purpose-built facility with flexible capacity can help biopharmaceutical companies bring their products to market quickly and efficiently.

• Cryopreservation Of Cells: Preserving Cells For Future Use

  Take a closer look at the process of cryopreservation, which role it plays for cell banking, and which challenges have to be overcome to reach the successful cryopreservation of cells.

• Revolutionizing Particle Characterization With Image Analysis And ML

  The biopharmaceutical industry is increasingly employing micro-flow imaging for particle characterization, owing to the superior insights it can afford into product quality and process controls.

• 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.

• Case Study: Connexin Is Taking The UK's 'Smart Cities' To The Next Level

  With Skedulo, Connexin is streamlining processes via automation, increasing connectedness between their office & field teams, and elevating their customer experience.

• Leading European CDMO For Drug Product Manufacturing

  As timelines tighten and regulatory demands grow, discover how a European CDMO delivers integrated solutions from aseptic fill and finish to packaging and release.

• Perspectives On Performance, Scalability, And Regulatory Compliance

  Here, we discuss the challenges and solutions for cell and gene therapies, focusing on performance, scalability, and regulatory compliance to accelerate commercialization and improve patient access.

• Unravelling The Complexities Of ADC Manufacturing

  Whether you're in the early stages of development or scaling up for commercialization, understanding ADC manufacturing challenges is essential for bringing life-saving therapies to patients worldwide.

• Electronic Batch Reporting

  Learn how a CDMO automatically created a comprehensive batch report model to drive their reporting and speed root cause identification of quality failures with an Industrial DataOps software solution.

• A Unified Approach to Clinical Trials

  Learn how developing a unified solution can improve quality and create efficiency and cost savings for organizations of all sizes conducting clinical trials of all types.

• Build An AAV8 Platform: Lessons From A Collaborative Development Journey

  Explore how a modular AAV8 platform enables scalable, GMP-ready gene therapy manufacturing with reproducible outcomes, streamlined tech transfer, and adaptability across serotypes.