Pharmaceutical Industry

From Data to Direction.  Scientists and engineers at the R&D, pilot, and production scales need a new way to harness the power of the data gathered… a new way to drive innovation through an enhanced data strategy. Crucial elements for enabling pharmaceutical process innovation include:

  • Understanding the key physical situation of the process.
  • Identifying the right process analytical technology to obtain the required data.
  • Automating the storage and connectivity of that data.
  • Implementing data visualization tools that make it easy to analyze and make changes to improve quality of processes and the resulting medicines.

Companies often capture all the data they need to improve operations within their data historians and other databases.  However, creating insight from this information can be difficult, expensive, and time-consuming using traditional approaches or limited data analytics tools. For example, it is important to ensure that your data management applications provide:

  • A strong connection with all data historian(s).
  • Automatic indexing of the sensor names or tags in the historian for ease of searching time-series data.
  • A comprehensive connection to other data sources for the data points of interest.
  • Rapid visualization of the time series data over a designated period time.
  • Streamlined future analysis in a way that also facilitates collaboration.

With a facile data strategy, the world looks different. Imagine having the ability to easily search and interact with past and present time-series data in a “google-like” fashion and collaborate in real time. Imagine being able to make business critical decisions with more confidence simply because you have the data in hand. 

BIOPHARM INTERNATIONAL NOV 2016, LEVERAGING DATA ANALYTICS INNOVATIONS TO IMPROVE PROCESS OUTCOMES—By Lisa Graham, PhD: http://www.biopharminternational.com/leveraging-data-analytics-innovations-improve-process-outcomes

At the highest level, Figure 1 shows what is needed!

Figure 1: In-depth understanding of the functional relationship between upstream and downstream process variables enables target protein product characteristics

Alkemy Innovation works with a series of available technologies and tools that support optimal data management and retrieval.  For example, Alkemy Innovation leverages an application from Seeq that is dedicated to time-series data investigation and works with any process historian (e.g., OSIsoft PI System, Emerson Advanced Continuous Historian) and other database soures (Figure 2). With features like being able to easily search and interact with past and present time-series data in a “google-like” fashion and collaborate in real time, the Seeq tool is an example of a tool that supports the desire for intuitive, visual, and innovative data analyses.

Building upon data access and visualization tools, Alkemy Innovation leverages other tools like JMP, Spotfire, and Matlab to support the development of new models and correlations, along with their implementation into the day-to-day practices.

Example application:

Bioreactor process overview 

Figure 2: A more effective strategy to enable new data analysis across all bioreactors in the scale-up train can support 1) rapid problem-solving, 2) small-scale model verification, and 3) future process development

Seeq data management application in bioprocessing

Schedule of Events

We value participating in conference presentations, technical poster presentations, and webinars where we can learn about the latest technologies and also share specific case study examples that illustrate how to drive innovation through enhanced data visualization.  Using enhanced data visualization, factors that affect product quality can be rapidly identified further enabling definition of key performance indicators in early development. Leveraging historical data allows small scale model verification and insights into challenges of scale up.

Past Events: 

Upcoming Events:

  • Boston Biotech Week:  Bioprocessing International, September 25-28, 2017, Boston, MA.
  • Boston Biotech Week: Cell and Gene Therapy Bioprocessing and Commercialization: "Implementing Large Scale Data Processing and Analysis in Bioprocessing", September 25-28, 2017, Boston, MA.
  • Emerson Global Users Exchange, Workshop Co-Presenter: "Data Analytics Strategy Combining DeltaV and Offline Instruments", October 2-6, 2017, Minneapolis, MN.
  • ISPE Annual Meeting: "The Role of Data Analytics in Streamlining Process Development and Scale-up", October 29-November 1, 2017, San Diego, CA.

From Data to Direction.

Contact Info

Alkemy Innovation
alkemy@alkemyinnovation.com
541-408- 4175
Bend, OR