A proven track record in mammalian cell culture
We provide robust and scalable processes for manufacture of biopharmaceuticals for clinical and commercial supply.
Our development teams work closely with the manufacturing and quality assurance groups to define and document all new processes and to create robust manufacturing procedures. We perform a complete development program or individual work packages based on our customers' technology. Our services are flexible and are created through close partnerships with our customers throughout the lifecycle of their product.
Since 2001, we have transferred more than 500 customer processes into cGMP manufacturing for small, mid or large scale at all product lifecycle stages.
For the last 30 years our GS Gene Expression System® has been continuously improved for robust technical performance and is able to express a diverse range of biopharmaceuticals with high titers. The system is used within Lonza and is also available for out-license.
Tailorable technical scope and timelines when necessary to meet customers' needs
When you bring a non-Lonza cell line to us and you want us to evaluate our platform cell culture process, a typical initial process development study includes the assessment of inoculum expansion and production bioreactor processes, feeding strategies and cell line stability studies. This rapid evaluation will test if the platform is suitable for the cell line and product. If it is not, we use our expertise to adapt our platform process to improve productivity or match a specific product characteristic.
We have transferred-in processes for a variety of expression systems and cell lines. The activities we undertake are driven by customer needs and they can range from ensuring fit to our manufacturing plant to optimization to improve product quality or productivity and on-to scale-up before being transferred into our manufacturing network.
Get a robust and reproducible platform manufacturing process
Our platform manufacturing process is robust and reproducible, with scalability proven up to 20 kL. Our well-characterized platform process offers many benefits to you:
- Accelerated timelines. Because our cell lines are selected to fit our platform process, this leads to higher success and lower error rates.
- Simpler troubleshooting. If excursions occur, troubleshooting and if needed, modifying a platform process containing our proprietary culture media and feeds is easier than for a customized one.
- 35+ years' experience in developing processes for cGMP manufacturing enables us to support you to optimize your existing process for commercial manufacturing.
- Quick identification for critical process parameters to speed up process characterization and validation activities.
Broad experience with regulatory agencies across the globe and process validation in mammalian systems
Over the past 5 years, we have provided the complete CMC documentation for more than 15 biological full BLA / MAA, including products with Breakthrough or PRIME designation. We develop open and trusted communication channels with our customers, so that we can support them when they have to respond to the authorities’ questions.
The CMC section of a successful BLA application requires good planning, good science and a thorough understanding of the process and product profile. We take a structured approach to developing a tailored program for each product and process that considers all CMC aspects of a BLA program.
We have developed a strategy that supports products with accelerated approval pathways. The scope of the studies performed is dependent on your needs and the current regulatory guidelines.