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Solution Brief

Yield Prediction

Bigfinite’s AI-powered, GxP-qualified platform offers a range of functionalities that allow for the creation of a fully adaptable, real-time solution to help production teams anticipate bioreactors’ poor performance and as a result, achieve higher product quality.

Solution Brief

Principal Component Analysis

Bigfinite’s multivariate monitoring tools and especially the PCA, allow manufacturers to, on one hand obtain a better understanding of the manufacturing process and, on the other hand, see in real time when their process is deviating from the expected behavior even before variables are out of control. This is because these functionalities analyze the combination of para...

Solution Brief

Multivariate Monitoring – Outlier Detection

Bigfinite’s multivariate monitoring and outlier detection provides manufacturers with real-time feedback when their process is deviating from the expected behavior, even before individual variables are out of control.

Solution Brief

Bigfinite Contextualization Functionalities

Bigfinite provides a regulated, secure, and encrypted data lake for GxP environments to acquire data and transform it into knowledge, dismantling data silos, and enabling data contextualization.

Solution Brief

Regulated Data Lakes to Break Data Silos

Regulated industries and organizations face tremendous pressure to meet increasingly stringent regulatory requirements. This requires highly specific security measures and restrictions. Learn how Bigfinite can help you destroy those data silos!

White Paper

AI Algorithm Qualification for Pharma Manufacturing

This paper explores a Quality by Design (QbD) approach to applying Artificial Intelligence (AI) in pharma manufacturing, and demonstrates how Bigfinite’s GxP-compliant AI software-as-a-service (SaaS) platform can be leveraged to qualify AI algorithms for pharmaceutical product and medical device productivity chains.


How to Design a Sensor Data Solutions – Part 2

6/17/2020 | 35:43 minutes

Following on the first demo on designing and building sensor data solutions, learn more advanced techniques to take your solution to the next level using the Bigfinite platform!


How to Design a Sensor Data Solution – Part 1

6/10/2020 | 39:00 minutes

Learn how easy it is to build your own application to monitor sensor data using the Bigfinite platform!


How to Scale a Multi-site Analytics Solution

5/21/2020 | 28:49 minutes

See how Bigfinite can help you scale operations from a single site to multiple sites efficiently!


Why Biotech and Pharma Need GxP for their Digital Transformation Projects Now

3/9/2020 | 57:30 minutes

Pharmaceutical manufacturers are under increasing pressure to fast-track technological innovation to improve their manufacturing operations in order to adapt to new approaches like ‘Industry 4.0’ and continuous manufacturing, combat the growing and intense competition and keep up with the increasing demand for personalized medicine and therapies. But with an industry with the world’s tightest r...


Multivariate Deeper Root Cause Analysis

4/29/2020 | 31:31 minutes

Watch a short demo on Bigfinite's solution for Multivariate Deeper Root Cause Analysis which includes showing the first Principal Component Analysis, or PCA, in the cloud and learn the benefits of using this tool in an AI-enabled, GxP platform.


Data Contextualization and GxP Data Lakes

4/22/2020 | 31:31 minutes

Watch a demo on Data Contextualization and GxP Data Lakes where Bigfinite walks you through the challenges and complexities of data contextualization in the highly regulated pharma environments and how Bigfinite can help.


Data Collection in an Age of Compliance

4/15/2020 | 23:08 minutes

Watch a demo on how Bigfinite can help you in Data Collection in an Age of Compliance where Bigfinite will walk you through the challenges and complexities of capturing data in the highly regulated pharma environments and how Bigfinite can help.

Case Study

Predictive Pooling Strategy: Global Biotech Company Reduces Risk in Downstream Purification

In this case study, a biotechnology site needed to improve the yield of their downstream processes. They produced a rare disease medicine with a value of hundreds of thousands of dollars per gram, meaning process optimization was vital. Though they had access to a wealth of historical data, they were forced to manually gather and correlate data, slowing the process and creating potential for hu...

White Paper

The Bigfinite Bioreactor Application

This paper will explore the most important data challenges experienced by the rapidly modernizing pharmaceutical industry and propose a GxP-compliant, ready-made application as a solution designed to increase efficiency in upstream processes, while maintaining data integrity and compliance.


How Does AI Qualification Work?

5/5/2020 | 64:12 minutes

Quality is a big topic in pharma circles and can hinder progress towards the promises of digital transformation in manufacturing operations. This would solve many headaches from understanding your operational realities to quickly identifying the root causes for deviations and even the predictive capabilities of avoiding downtime. Artificial Intelligence (AI) promises deterministic pre...

Case Study

“Right First Time” Operation for Improved Process Robustness

A multinational biopharmaceutical company was looking to reduce their operational inefficiencies and reduce costs by avoiding numerous recirculations at their ultrafiltration process step. Even with a lot of effort and analysis, they struggled to get the targeted concentration of the drug product (polarimetry) correct or “Right First Time.”

Solution Brief

Deeper Root Cause Analysis

You’re under increasing pressure to perform and you know that taking advantage of emerging technologies is a key strategy to reaching your market leadership aspirations. Bigfinite can help you get there. See how Bigfinite’s platform can help you from data ingestion through to actionable analytics to help you get to the root cause of deviations faster, all within a GxP-compliant environment.


Real-time Outlier Detection to See the Full Picture

5/13/2020 | 30:54 minutes

Watch this demo of Bigfinite's Real-time Outlier Detection to See the Full Picture to see how Bigfinite’s AI-enabled, GxP platform can help you detect outliers real-time, in the cloud.