# LABORATORY SCALE SYSTEM FOR CONTINUOUS PURIFICATION OF BIOPHARMACEUTICALS

> **NIH NIH R43** · PAK BIOSOLUTIONS, INC. · 2022 · $324,999

## Abstract

PROJECT SUMMARY/ABSTRACT
PAK BioSolutions, Inc. (PAK Bio) is an early-stage company creating continuous bio-manufacturing equipment
that solves the unmet needs of process development scientists and manufacturing personnel aiming to shorten
drug development timelines and manufacturing costs. There are no vendor supplied systems that enable a fully
integrated continuous process at the laboratory scale. We are currently focused on the development of a
laboratory scale version of our Pilot PAKTM purification system, the first commercial fully continuous system on
the market that enables up to 4 unit operations to be run simultaneously. This laboratory scale version will allow
scientists to quickly and efficiently develop a continuous process using a single system capable of running all
unit operations commonly used in a bio-manufacturing process. Batch manufacturing is the industry standard
and has progressed little in the past few decades. This manufacturing modality requires capital-intensive
stainless-steel facilities and results in low productivity (drug/time/cost). At benchtop scale, scientists must use
the same batch techniques which slow down process development time due to the segmented nature of this
manufacturing style. These studies are not only time intensive, but do not accurately reflect the complex process
dynamics found in a continuous process. Additionally, many continuous unit operations operate in a
fundamentally different way than their batch counterparts (e.g., flow through virus inactivation and single pass
diafiltration). These operations require a scaled down continuous system to properly develop. Our aim through
this funding opportunity is to develop a laboratory scale version of our existing manufacturing scale system for
use in continuous process development. The “Micro PAK” system would provide process development scientists
with a unique tool to develop a continuous process with scaled down continuous unit operations. Scientists could
confidently optimize the process and quickly scale up to manufacturing scale with minimal to no changes in the
processing modality. Time and resources saved by the Micro PAK would translate into cheaper $/gram
manufacturing costs and increase the likelihood of successful scale up of a continuous process from
development to production. Continuous processing has been of interest to nearly all major biopharmaceutical
organizations. With a projected cost of a Micro PAK system to be $325,000, we estimate an annual market value
of $91M/year. To set us on the path towards commercialization, we propose to first develop a functional prototype
capable of running a continuous process from initial capture through final drug substance on a 1L cell culture/day
scale. After successful completion of this Phase I feasibility study PAK Bio will further optimize and validate the
system. We will then conduct extensive beta testing through a series of Design of Experiments studies comparing
critical quality attr...

## Key facts

- **NIH application ID:** 10480679
- **Project number:** 1R43TR003975-01A1
- **Recipient organization:** PAK BIOSOLUTIONS, INC.
- **Principal Investigator:** Joanna Frances Rucker Pezzini
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $324,999
- **Award type:** 1
- **Project period:** 2022-06-06 → 2025-06-05

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10480679

## Citation

> US National Institutes of Health, RePORTER application 10480679, LABORATORY SCALE SYSTEM FOR CONTINUOUS PURIFICATION OF BIOPHARMACEUTICALS (1R43TR003975-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10480679. Licensed CC0.

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