Inventprise offers our diverse services in biologics from process-to-end user. We have wide ranging experience in process development, optimization, servicing analytical needs and manufacturing from early clinical trials through commercialization.
We can assist in advancing your program by leveraging our subject matter experts in protein purification, cell culture, conjugation chemistry, and automated commercial manufacturing.
Inventprise’s Process Development and Analytical Development capabilities support the development and optimization of protein processes. Our scientific team works closely with our partners to optimize their process in order to comply with phase-appropriate regulatory guidelines and ensure a consistent, high-quality product throughout clinical development and commercialization.
For partners with early stage processes, we work to improve their processes and recommend combinations of approaches, with the goal of improving product quality, step yields, and reducing manufacturing cycle times.
Clinical & Commercial Manufacturing
Through the combination of our Operational Strategy and Proprietary Electronic Data Management System, Inventprise enables our Partners to deliver their products to patients efficiently, cost-effectively, and with the highest quality.
Defined process flows ensure product integrity (Chain of Identity & Chain of Custody) from material through processing, storage and shipment from Inventprise to the Health Care Provider.
All manufacturing and logistics data are monitored 24/7 by the cross functional Inventprise team
Quality and Regulatory Programming
Our Quality System is designed to align with applicable domestic and international regulatory criteria and industry standards, consistent with the Inventprise Quality Policy Statement.
Our quality and Regulatory programming enhances the entire product development lifecycle, up to and including regulatory product approvals and commercialization, usimg state-of-the-art GMP-compliant manufacturing technologies and testing laboratories and methodologies. Emphasis is placed upon data integrity, using automated systems which are validated.
This success extends outside of inventprise to our stakeholders: suppliers, contract customers, investors, regulators and end users — who are welcomed as partners in ou mission to provide critical healthcare solutions to the marketplace.
For state-of-the-art manufacturing, Inventprise is implementing a comprehensive automation strategy with a focus on our key goals — maximum use of automation, tight integration of the entire process train to support continuous manufacturing, and maximum automated data collection for increased observability and monitoring.
We are aligning our strategy with existing well-established integration frameworks such as ISA-95, process control standards such as ISA-88, and adopting Pharma 4.0 principles.