Greatest race in the 21st century?

Our healthcare providers are working harder and more bravely than ever before, saving lives while risking their own life, as the rest of us are doing our best to flatten the infamous curve.

In parallel, many of the smartest minds in the world are racing to find a vaccine or treatment for the Covid-19 virus.

Today, April 16,there are 79 companies driving toward a solution, but who will win and what is needed to get the checkered flag?

The intermediate line is often defined as time-to-clinic while the finish-line is often identified as time-to-market. In this race, however, the true victory is when time-to-patient is reached: not to just the lucky few, but to the all of us helping to stop the pandemic and that will help our entire society to survive both the virus and the colossal economic side effect.

Data is the key to knowledge management, ICH Q10 as we reach for the checkered flag:

Knowledge management

Product and process knowledge should be managed from development through the commercial life of the product up to and including product discontinuation. For example, development activities using scientific approaches provide knowledge for product and process understanding. Knowledge management is a systematic approach to acquiring, analysing, storing and disseminating information related to products, manufacturing processes and components. Sources of knowledge include, but are not limited to, prior knowledge (public domain or internally documented); pharmaceutical development studies; technology transfer activities; process validation studies over the product lifecycle; manufacturing experience; innovation; continual improvement; and change management activities.

What is the result of solid knowledge management?

 We have seen examples where companies have been able to reach markets faster than before and at the same time reduce cost of production by 80% compared to normal for monoclonal antibodies, mAb. Several impressive numbers are behind this significant cost reduction for example, a high yield and productivity, 300% higher than typical. Simultaneously significantly fewer exceptions which can cause costly out-of-specifications investigations, 70% fewer than normal. This by using advanced analytics for advanced process control by MPC in combination with golden batch technology and multivariate prediction and prescriptive data analytics.

This is enabled by data, more specifically by easy access information that is used in a proactive rather than reactive manner to increase throughput and quality at the same time, all enabled by Data Integrity and Knowledge Management

The greatest race will be won when there is a vaccine or treatment for the Covid-19 virus that has been safe and effective and additionally transferred to a large number of production plants releasing high quality products at minimal cost in the shortest possible time.

Want to learn more?

There are hundreds of use cases from PI World over the years, and this is one of my favorites which is worth watching at any time, and particularly now.

To our brave healthcare workers and to everyone in the race, we are cheering for you.

Stay healthy

Petter

OSIsoft Global Industry Principal, Life Sciences