Software, the company providing the QbDVision® platform to
accelerate the development of manufacturing processes for the
pharmaceutical industry, announced today significant new features,
including process capability analytics, expanded support for Contract
Development and Manufacturing Organizations (CDMOs and CMOs) and
consultants, and data import capabilities for faster project setup and
data ingestion. QbDVision is the first-of-its-kind, cloud solution for
risk-based management of pharmaceutical process development. The
platform captures and aggregates drug development knowledge over time
for smarter development within a single, validated solution.
“We are fundamentally changing how the pharma and biotech sectors
approach product life cycle management,” said Yash Sabharwal, President
and CEO, CherryCircle Software. “The antiquated solutions used today
inhibit holistic process development that would speed drugs to market
with lower manufacturing costs. Development is becoming increasingly
more complex with new, small-batch cell, gene and curative therapies,
and this will require smarter and more efficient manufacturing.
QbDVision is enabling knowledge and quality risk management over the
development lifecycle, revamping how the drugs of tomorrow are advanced
With over 100 new capabilities and improvements created through active
customer, partner and adviser feedback, QbDVision unites robust data
importation tools with novel visualization, risk management and
analytics for assessment of process capability within a 21 CFR 11
environment for the most powerful structured knowledge management
“These recent platform enhancements advance our mission to help pharma
companies deliver the highest quality pharmaceutical therapies to market
faster and at a lower cost with better design and control of complex
manufacturing processes,” said Sabharwal.
Features of the updated platform include:
New import functionality – Existing projects and processes set
up faster by directly importing project records, suppliers and users
with Excel. Track and manage process performance data by uploading
batch data or continuous data from manufacturing runs.
Integrated data analytics – Automate process capability
analytics of manufacturing data. New functionality allows end users to
automatically calculate KPIs and support data-driven decisions about
process definition and control.
Improved reporting – New reporting capabilities allow customers
to visualize and work with data across systems.
Support for contract manufacturers (CDMO/CMO) and consultants –
Amplified collaboration capabilities make it easier to work in teams,
and project-level security permissions provide specific access
control. Features expanded for creating templates and cloning existing
records for platform-level process management.
The Mandate to Modernize Pharmaceutical Drug Development and
Biotech and pharma manufacturers have historically used multiple,
poorly-integrated software tools for knowledge management. This approach
has hampered risk-based process development and compromised data
integrity. This is one of the many facets contributing to an average of
$2.5 billion and 11 years for a drug to be created and sold.1
QbDVision provides a streamlined knowledge management structure that can
improve the quality of drugs by unifying and simplifying the product
management process. It provides an integrated repository to preserve
knowledge; track the evolution of risk based on data and scientific
rationale; improve manufacturing efficiency; and help constituents
navigate the changing regulatory environment.
Tailored for process engineers, chemists, technical operations teams and
quality/regulatory groups in the biotech and pharma sectors, the
platform employs serverless technologies and automated testing tools for
the rapid development and deployment of secure, validated solutions that
enable process and data management under a quality-by-design (QbD)
framework with minimal IT burden.
About CherryCircle Software, Inc.
CherryCircle Software, Inc. builds cloud-based solutions to help the
pharmaceutical industry reduce the time and cost of development, and
increase the availability and affordability of essential therapies for
patients. Its flagship platform, QbDVision®, provides the pharmaceutical
industry with simple, yet powerful tools to facilitate robust
manufacturing process development and product life cycle management
driven by data and science, enabled by people, and powered by innovation
and automation. Founded in 2016 by pharmaceutical manufacturing and
quality experts, CherryCircle is headquartered in Austin, Texas, and is
an active member of the International Society for Pharmaceutical
Engineering (ISPE). For more information, visit www.qbdvision.com,
and follow on Twitter at @QbDVision.
1 Tufts CSDD R&D Cost Study