Dr Ruth Rowland-Jones

by Ruth Rowland-Jones
Senior Principal Scientist, Process Development

Biopharmaceutical manufacturing is in the midst of a transformative phase. As the demand for more complex molecules grows, we’re seeing a shift towards enhanced efficiency and productivity.

Optimizing bioprocess intensification

As a Senior Principal Scientist, I oversee and support the global implementation of Lonza's Process Intensification Platform (Figure 1). Process intensification helps to accelerate innovation through advanced biopharma process development techniques, technologies and improved manufacturing platforms. Lonza’s core concept revolves around optimizing bioprocessing intensification, focusing on the N-1 and production stages.

Figure 1. Lonza Biologics’ fed-batch intensification platform process
Exponential cell growth for a longer period of time

Our new biopharma process involves implementing a perfused N-1 stage during the inoculation train where fresh, nutrient rich medium is continuously added to the bioreactor - whilst cell-free spent media is removed via a filter. This sustains exponential cell growth for a longer period of time, resulting in higher cell densities.

Reducing the cost of goods at commercial sale

This can then be used to inoculate the perfusion bioreactor at a higher seeding density, operating it as a high inoculum density fed-batch production process. Operating this way enables the culture to reach maximum viable cell concentration sooner - meaning more product can be produced in a shorter period of time - and reduce the cost of goods at commercial sale.

Significant reduction in production time

This strategic alteration has led to remarkable outcomes, including a reduction in production time from 15 days for a typical fed-batch process to 12 days. Also, on average, an impressive 79% increase in titres titres (and up to >140% increase in some instances), as shown in Figure 2, across various cell lines - encompassing monoclonal antibodies and more intricate molecules like bispecific antibodies.

Figure 2. Increased product concentration with HID when compared to traditional fed-batch process. *Lonza mAb producing cell lines
Precise monitoring and control of the bioreactor environment

One of the keys to successful development of perfusion bioprocesses is understanding what’s occurring in the bioreactor so that the process can be well-controlled.

We have integrated innovative and advanced Process Analytical Technologies (PAT) such as:

  • Real-time capacitance measurement
  • Raman spectroscopy

These allow for precise monitoring and control of the bioreactor environment. This level of sophisticated control (based on real-time data, non-destructive analysis) is critical to the platform's efficiency and effectiveness across multiple cell lines, making it adaptable for standardized use in various production settings.

From research and development to practical implementation
lab technician working at base of equipment

The successful launch of the Process Intensification Platform in 2023 marked a significant milestone, transitioning the technology from the research and development phase to practical implementation in Lonza's manufacturing facilities.

Notably, this innovative platform is now operational in facilities in:

  • The UK (for development up to 1kL)
  • Singapore (for development)

There are also plans for integration into sites in the US (2kL) and Switzerland (20kL).

Supporting customers at every stage of biopharma process development

It’s been a privilege to witness and play a key part in the immense teamwork, communication and collaboration across different global sites that have brought this new bioprocess intensification technology to life. The standardized implementation of this platform globally is a testament to their dedication and deep expertise.

It is a monumental achievement that enables Lonza to better support our customers’ through every stage of the product development lifecycle.

About the author:

Ruth Rowland-Jones is a senior principal scientist in the Global Biologics Technical Development group at Lonza Biologics. Ruth has 10 years of experience in biopharmaceutical process development, including work with implementation of advanced process analytics and multivariate data analysis at companies including GSK. At Lonza, Ruth is a global technical implementation manager, supporting the implementation of many projects across the network, including the Lonza fed-batch process-intensification capabilities described in this report and numerous internal digitalization projects.