Improving Process Understanding Across the Product Lifecycle

QbDVision Briefing Note

By Daniel R. Matlis

The Executive Management team at CherryCircle Software recently briefed Axendia on QbDVision®, its cloud-based Product Quality and Lifecycle Management platform integrating product, process, and quality management for Bio-Pharma.

Started in 2017, and headquartered in Austin, TX, the company was founded by Yash Sabharwal, Ph.D., former Co-founder & COO of Xeris Pharmaceuticals and Ryan Shillington, a seasoned software CTO.

“Our mission is to help our customers accelerate therapies to patients by deploying the latest digital and automation technologies which reduce the time and cost of product development without sacrificing product quality,” said Sabharwal.

Built on ICH Pharmaceutical Product Lifecycle Management Guidelines

ICH Q12 is the globally harmonized guideline that builds upon the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). These guidelines to provide a framework on the technical and regulatory considerations for Bio-Pharmaceutical product lifecycle management.  Through Q12, global regulators intend to promote innovation and continuous improvement in the bio-pharmaceutical sector, strengthening quality assurance and improving the supply of medical products.

QbDVision is a cloud-based, closed-loop suite of software solutions built on the ICH Q8 through Q12 framework. The solution seeks to integrate knowledge, risk, quality, and project management to support the evolution of process development and validation across the product lifecycle.

According to Sabharwal, “QbDVision is a unique software solution created by industry veterans to capture the evolution of the drug manufacturing process from laboratory-scale to continued process verification using the principles of ICH standards and Pharma 4.0.”

Source: QbDVision

Improving Process Understanding Across the Product Lifecycle

Axendia’s research shows that Life-Science companies are not short on data.  Industry Companies have horded Yottabytes of data that are sitting idle.  As a result, we are drowning in meaningless data due to the lack of process understanding.  Unfortunately, this lack of process understanding is the primary  barrier to implementing Quality Metrics across the Life-Sciences industry, according to a recent Axendia poll.

This challenge is intensified by the increasing complexity of medical products and their manufacturing processes. As a result, existing frameworks for knowledge management using point solutions, spreadsheets, reports, and file repositories are not sustainable.

“Knowledge is power and process understanding is gold,” responded Sabharwal. “The Pharma 4.0 paradigm is a new vision for pharmaceutical manufacturing that relies heavily on quality-by-design principles using science-based, data-driven, analytical frameworks to create robust, flexible manufacturing processes,” he added.

QbDVision seeks to meet this challenge by providing a structured framework for knowledge management that allows organizations to drive process understanding and intelligence while automating compliance with regulatory requirements. 

Source: QbDVision

“The best practices and workflows enabled by QbDVision provide a flexible environment where requirements, risk, data, and analytics all come together to inform process development activities in real-time akin to agile development methodologies,” commented Sabharwal. “Going beyond ‘the what’ and ‘the why’ of product lifecycle management, QbDVision sharpens the focus on ‘the how’ of effectively implementing these methodologies effectively within your organization,” he continued.

In Brief

With the adoption of ICH Q12, Axendia continues to see increased interest from Bio-Pharma companies in solutions that integrate knowledge, risk, quality, and project management to support the evolution of process and regulatory requirements across the product lifecycle.

Improving process understanding across the product life cycle is the key to accelerating innovation and continuous improvement in the Bio-Pharmaceutical industry, resulting in enhanced quality and availability of medical products.

Developed by industry veterans, QbDVision is a unique software solution well positioned to capture the evolution of the Bio-Pharma manufacturing process from laboratory to commercial scale based on the ICH standards.

We will continue to monitor QbDVision’s solution in the Bio-Pharma industries.

The opinions and analysis expressed in this Briefing Note reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this document is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This document is not intended to endorse any company or product and should not be attributed as such.