Raw Materials Management: Technology Advancements Improving Transparency And Global Collaboration

Thought leaders from across the industry gathered at the Raw Materials Variation and Control Symposium for the shared mission of ensuring a consistent supply of safe and effective drugs to patients who need them. Experts from Biogen, Amgen, and GE Healthcare Life Sciences shared insights on how they are pushing the limits and creating new boundaries to overcome raw material variability.
How Biogen Integrated Process Analytics Technology With End-To-End Supply Chain Transparency
Amgen’s Digital Transformation: Linking Raw Material Data From Suppliers To Patients
Raw Material Variability Control: Where Do We Go From Here?

Download the full eBook here.

Featured Editorial
How Will Trump’s New FTC/DOJ Reporting Requirements Impact Biosimilars?
By Limin Zheng, Ph.D., GCA Law Partners LLP

On October 10, 2018, President Trump signed into law the Patient Right to Know Drug Prices Act, which, among other things, requires that certain biosimilar applicants and reference product sponsors involved in patent disputes file their settlement agreements with the FTC and the DOJ. This article summarizes the key provisions of the new law and discusses its limitations.

Change Of Focus For Biopharma Manufacturers
By ISR Reports

In Q42017, ISR asked 730 buyers of outsourced manufacturing services about upcoming changes to their pipeline and how those might impact their outsourcing practices. 

Industry Insights
Purification Of Antibody Fragments And Single Domain Antibodies
White Paper | By Gerald Platteau, et al., JSR Life Sciences

The wide range of antibody fragment variants for which Amsphere A3 can be used as a capture resin is described, together with insight to the related binding mechanisms obtained via X-ray crystallography.

Qualification And Validation Of Isolator Systems
White Paper | By Jürgen Metzger and Andrey Yermakovich, Bosch Packaging Technology

Successful qualification and documentation processes start in the planning phase of a project then follow through manufacturing and the life cycle of the equipment.

Cell And Gene Therapies: A Guide To Single-Use Connections
Article | By Derek Pendlebury, CPC

This article captures high-level learning about the use of single-use technologies (SUTs) in biopharmaceutical manufacturing that can be applied to cell and gene therapies (CGTs), with a special focus on connection technologies.

The Cost Of Pharmaceutical Research Data Errors
Infographic | IDBS

Scientific experimentation and research and development (R&D) ventures can often be time-consuming and costly. So, it’s vitally important that all data is created and recorded correctly. 

Collaborative Project To Accelerate Downstream Biosimilar Processes
Case Study | GE Healthcare Life Sciences

This case study demonstrates the optimization of the downstream purification process to improve product purity and recovery of the biosimilar Fc-fusion protein.

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