Case Study

At Laureate Pharma, Inc. we provide quality-driven solutions in order to deliver our clients’ protein therapeutic drugs successfully time after time. We have overcome unique challenges in each case and we share with you some examples of our successful projects.

cGMP Production of antibodies –
from a vial of cells to bioreactor cGMP Scale-up

Introduction

A biotechnology company with a focus on development of monoclonal antibody-based therapies for treatment of various diseases approached us to produce pre-clinical material
for toxicology studies as well as cGMP material for Phase 1 studies.

The Challenge

Our client company had a well-developed process that was ready for technology transfer. They had completed cell line development and media development and were successful in scaling up to small-scale (5L) bench-top bioreactors. However, they had no capability for large-scale production of their biotherapeutics. The client wanted Laureate to complete tech transfer and generate toxicology materials within 6 months, followed by production of Phase I materials within 9 months.

Laureate Solution

The amount of cGMP therapeutic material required for Phase I stipulated that we use a 2000L stirred tank bioreactor. We developed a successful process flow starting with a vial of Master Cell Bank cells and scaled them up in sequence in Wave 20L, 50L, 200L and 1000L bioreactors to inoculate our 2000L stirred tank bioreactor for production of product. One of our challenges in the process was to scale-up the high density and high antibody yielding CHO cells in the 1000L Wave bioreactor® to generate inoculum for the 2000L stirred tank bioreactor. To sustain the maximum viability of the cells in this large vessel, we developed optimal mixing speed by adjusting both the angle of rocking and the rock rate. Using this model we prepared the entire seed train using Wave disposable bioreactors and generated inoculum for the 2000L production reactor. The scale-up was successful and the process yielded the desired amount for phase I clinical study for our client. By using single-use technologies such as Wave bioreactor we were able to eliminate time and resource consuming clean-in-place procedures and streamline the entire manufacturing process. We completed the optimized scale up process within the time frame and the budget as stipulated by our client.

Successful Outcome:

We matched the cell growth curve done at bench scale to large-scale process and the cell growth profile closely matched that of the client’s runs. We successfully supported the high density and high titer 2000L bioreactor. We delivered Phase I clinical material within the timeline with increased productivity and efficiency and on budget.

Striving to be your #1 preferred partner in biomanufacturing.

Contact:
1-609-928-5700
[email protected]
www.laureatepharma.com