Newsletter | April 8, 2020

04.08.20 -- Inside FDA's AI-Based Established Conditions Pilot

 
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Featured Editorial
Inside The FDA’s AI-Based Established Conditions Pilot
 
By Matthew Pillar, editor, BioProcess Online

FDA-CDER’s Geok Yan Loo gave us an inside look at CDER’s application of artificial intelligence to inform and improve pharmaceutical quality systems. The pilot offers good reason to consider how machine learning can improve bioprocessing quality and ease your regulatory burden.

Facilitating Great Virtual Meetings During A Pandemic (Or Any Other Time)
By Amanda McFarland and James Vesper, ValSource

Even before the global pandemic of the novel coronavirus, virtual meetings were on the rise. With a large percentage of people working from home, it's now a public health imperative. Here's how to facilitate a risk assessment, root cause investigation, or something similar via “virtual facilitation” with team members and subject matter experts scattered around the world.

Industry Insights
How The Integration Of CDMO And CRO Services Benefits Everyone
Article | By Justin J. Kim and Kenneth McMahon, Samsung Biologics

The integration of CDMO services with CRO analytical testing enables high-quality biologics products, speed-to-market, greater flexibility, and no dependence on external service providers.

Is Your Biologics At Risk For Protein Aggregation? Part 1
Article | By Martin Gonzalez, Ph.D., Pfizer CentreOne Contract Manufacturing

This is the first installment in a three-part series that examines what causes protein aggregation and practical steps you can take to mitigate the risk.

Single-Use Platforms Accelerate Viral Vaccine Development And Manufacturing
White Paper | By Amélie Boulais, Sartorius Stedim Biotech

Biopharma analysts predict the market for vaccines could grow at a compound annual growth rate of as much as 10.3 percent through 2024. Single-use platforms that eliminate reinvention of the wheel for each candidate might be pivotal to meeting that demand.

Introduction To Mass Transfer In Single-Use Bioreactors
White Paper | Thermo Fisher Scientific

Mass transfer in single-use bioreactors is complex and often misunderstood, yet critical to the growth of cells in culture. This paper aims to elucidate the standard mass transfer model.

An End-To-End, Semicontinuous Process For mAb Production
Application Note | GE Healthcare Life Sciences

See how the different unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected and integrated into a semicontinuous process.

Are You Protecting Your Employees During HPAPI Manufacturing?
Q&A | Ajinomoto Bio-Pharma Services

As biomanufacturers venture into the rapidly growing market of HPAPIs, it is important to consider whether they have the resources and capabilities to protect their product and their employees.

Partnering With Your Teams To Enhance And Increase Supply Chain Efficiency
Case Study | Thermo Fisher Scientific

How an emerging biopharma and a clinical services company partnered to maintain timelines and meet funding milestones when faced with a lack of bandwidth and limited global organizational experience.

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Life Science Training Courses
Reacting To “Human Error”: Moving Beyond “Retraining” As A Response

April 15, 2020 | 1:00 PM EDT

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