Newsletter | July 8, 2019

07.08.19 -- AI, Data Integrity, & Biopharm: Let's Not Wait Until Someone Dies

Featured Editorial
AI, Data Integrity, And Biopharm: Let’s Not Wait Until Someone Dies
By Kip Wolf, Tunnell Consulting, @KipWolf

Data integrity and quality are critical success factors for artificial intelligence (AI) and machine learning (ML). Here's why standard computer system validation and cGMP management standards are inadequate for data sets subject to AI and ML in biopharma.

Developing Optimal Biopharmaceutical Quality Control Strategies
By Mark F. Witcher, Ph.D.

How can the industry improve product quality? We can start with more vendor inspections, enforced compliance with supply agreements, and adherence to GMPs.

Industry Insights
Demystifying Extractables Testing
White Paper | By Graeme Proctor, Parker Bioscience, and Nick Morley, Hall Analytical

It is critical that single-use technology users understand the differences between the guidances available for extractables analysis and which testing approaches are most suited to the study goals.

3 Steps To Better Extractables And Leachables Studies
Article | By Aryo A. Nikopour, Nitto Avecia Pharma Services

There is no shortage of guidance for conducting extractables and leachables studies. The trick is aligning standards that overlap.

The Current Landscape For Developing Biosimilars In India
Article | By Ankita Bhargava, senior research fellow at the Department of Chemical Engineering, Indian Institute of Technology in Delhi, India

As India’s biosimilar market moves toward a promising future it is important to gain an overview of the current regulatory and clinical expectations in India for biosimilar products.

Complex Molecule Development: Early Considerations To Avoid Late Failures
Article | By Andreas Stolle, Ph.D., and Peter Poechlauer, Ph.D., Thermo Fisher Scientific

How to understand and prepare for challenges early in development to avoid bottlenecks that significantly slow production and delay a drug’s time-to-market.

Comparing Continuous And Batch Processing In Downstream Purification
Case Study | Catalent

Continuous manufacturing technologies are being implemented to manufacture monoclonal antibodies, recombinant proteins, and other biological modalities. Here, we compare the productivity of purifications running in batch versus continuous mode.

Process Intensification Solutions For mAb Bioprocessing
Webinar | MilliporeSigma

Learn about polishing technologies that enable a fully flow-through polishing platform and how implementation of next-generation processing can positively impact facility fit limitations.

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