Therapeutic Protein Biomanufacturing Levels Up with Lonza’s Latest Platform

Lonza, a pioneer in the pharmaceutical and biotechnology industry, has unveiled the groundbreaking TheraPRO® CHO Media System, a cutting-edge cell culture platform designed to optimize productivity and improve protein quality when used with GS-CHO cell lines. This innovative launch aims to support pharmaceutical and biotechnology companies in their quest to elevate product quality while streamlining time-to-market, accelerating the delivery of life-changing therapies to patients.

Meeting the Demand for Antibody Therapeutics

With the increasing popularity and effectiveness of antibody therapeutics, the healthcare landscape is undergoing transformative changes. To meet the escalating demand for such therapies, biopharmaceutical manufacturers must enhance protein production processes and expedite the time-to-market. However, protein production can pose challenges, and unexpected hurdles during scale-up and production can drive up costs and cause delays.

A Solution from Lonza: The TheraPRO® CHO Media System

Lonza has developed the TheraPRO® CHO Media System, a revolutionary chemically defined, animal-component free, two-part production system that optimizes productivity and protein quality when used with the GS-CHO cell line, a prevalent mammalian host cell for therapeutic protein production. The system achieves high viable cell concentrations and a remarkable protein titer exceeding 5g/L during a 15-day culture cycle, representing more than double the titer achieved with existing solutions.

Designed for ease of use and scalability, the TheraPRO® CHO Media System streamlines media preparation and supports cell line development through bioprocess manufacturing. The components are manufactured in ISO 13485 certified facilities adhering to Good Manufacturing Practices (GMP), ensuring quality and traceability. Lonza’s subject matter experts provide extended support to customers.

The system includes TheraPRO® CHO Production Medium and Feed, available in powder format, supporting high cell density culture of GS-CHO cells. TheraPRO® CHO Expansion Medium, a convenient ready-to-use 1X liquid solution, supports cell expansion and post-transfection recovery of GS-CHO cells. TheraPRO® CHO Cloning Medium, also a ready-to-use 1X liquid solution, can be used with various cloning methods for GS-CHO cells.

Pioneering Biologics Manufacturing with a Simplified Approach

Deirdre (Eychner) Raduns, Senior Global Product Manager, Bioscience at Lonza, highlights that manufacturing high-quality biologics presents a complex challenge, especially when aiming for scale and speed. To tackle these challenges, the TheraPRO® CHO Media System draws upon decades of GS-CHO cell culture expertise, offering exceptional performance through a simplified, two-part production system. With this launch, Lonza continues its mission to facilitate faster market access for life-changing therapies, benefiting customers and patients alike.

Versatility and Expertise in Action

Dr. Harsh Amin, Director and Head of Protein Expression Media R&D at Lonza, emphasizes the system’s versatility and broad applicability. The media system has been carefully developed to ensure ease-of-use while delivering high titers and product quality. Its versatility allows for its utilization with various GS Knockout CHO cell hosts and supports diverse clones with distinct metabolic profiles.

Assured Quality and Regulatory Compliance

Lonza leaves no room for compromise when it comes to quality and regulatory compliance. All components of the TheraPRO® CHO Media System are manufactured in ISO 13485 certified facilities, adhering to good manufacturing practices (GMP). This ensures full product traceability and optimum lot-to-lot consistency, providing customers with peace of mind. Additionally, customers will receive a Drug Master File (DMF) and expert technical assistance with regulatory submissions, maximizing the likelihood of successful outcomes.

As the biotechnology and pharmaceutical industries continue their pursuit of excellence, Lonza’s TheraPRO® CHO Media System stands at the forefront, poised to revolutionize therapeutic protein manufacture and bring forth new possibilities in advancing patient care.

About Lonza

Lonza, a global leader in the healthcare industry, is dedicated to enabling a healthier world by supporting its healthcare customers in their journey towards commercialization. With a community of approximately 17,500 skilled employees spread across over 30 sites worldwide, Lonza serves the pharmaceutical, biotech, and nutrition markets.

Drawing on its combination of technological insight, world-class manufacturing, scientific expertise, and process excellence, Lonza helps its customers develop new and innovative medicines to treat a wide range of diseases. As a preferred global partner, Lonza focuses on enabling treatments that prevent illness and promote healthier lifestyles. By optimizing scientific innovation and manufacturing technology, the company empowers its customers to serve their patients and consumers effectively.

Lonza offers a broad range of services and products, ranging from early-phase discovery to custom development and manufacturing of active pharmaceutical ingredients, as well as innovative dosage forms for the pharmaceutical and consumer health and nutrition industries. The company’s extensive scale and resources enable it to provide a comprehensive one-stop solution, supporting people in getting well, feeling well, and staying well. In 2022, Lonza supported over 825 preclinical and clinical small and large molecules, more than 195 commercial small and large molecules, and produced approximately 250 billion capsules.

Established in 1897 amidst the scenic Swiss Alps, Lonza now operates across five continents, boasting a workforce of around 17,500 full-time employees who are high-performing teams and individual talents that positively impact their business and the communities they serve. The company embraces global supply chains while maintaining agility to address local marketplace needs.

Lonza places great emphasis on responsible business practices and sustainability. Reducing its environmental impact, conserving energy and natural resources, and enhancing life quality are at the core of its culture. Lonza’s Vision Zero initiative exemplifies its commitment to achieving zero workplace accidents and injuries, zero environmental incidents, zero product transportation incidents, and zero manufacturing process incidents. The company remains dedicated to attracting and retaining top talent to drive meaningful change within their business and communities.

In Full-Year 2022, Lonza generated sales of CHF 6.2 billion with a CORE EBITDA of CHF 2.0 billion. Lonza shares are listed on the SIX Swiss Exchange and Swiss Market Index (SMI), with a secondary listing on the SGX Singapore Exchange. As a leading global player, Lonza continues to make significant strides in the healthcare industry, forging a path towards a healthier and more sustainable future.

Learn more at lonza.com.

Engr. Dex Marco Tiu Guibelondo, BS Pharm, RPh, BS CpE

Editor-in-Chief, PharmaFEATURES