Robust and scalable processes for manufacture of biopharmaceuticals for clinical and commercial supply

With a proven track record in cell culture, we offer a complete range of development services to establish a cell line and process that meet your needs and are suitable for manufacturing product for clinical or commercial supply. We do this for both GS System® cell lines and cell lines brought to us by our customers.

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 customer’s technology.  Our services are flexible and are created through close partnerships with our customers throughout the lifecycle of their product.

  • Process Development

    Our platform manufacturing process is robust and reproducible, with scalability proven to 20000L. Our well-characterized platform process offers many benefits to you:

    • We provide accelerated timelines because our cell lines are selected to fit a process rather than having to develop a customized process for each new cell line leading to higher success rates and lower error rates as our plant operators are familiar with the process.
    • In addition, if excursions occur, trouble-shooting a platform process is more straightforward than doing the same for a customized one.
    • Our 35 years of developing processes for cGMP manufacturing enables us to support you to optimize your existing process to ensure optimal commercial manufacturing.   
    • We can very quickly identify critical process parameters (even in a process we have not developed or never run ourselves) to speed up process characterization and validation activities. We have made considerable investment in the development of proprietary culture media and feeds for cGMP manufacturing, which are chemically defined and animal component-free. This investment facilitates both trouble-shooting and process modification if needed to tune a product’s quality attributes.
  • 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 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 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. 

  • We have extensive experience with regulatory agencies across the globe and have validated a large number of processes for production in mammalian systems. In the past 5 years, we have provided the complete CMC documentation for >15 biological full BLA / MAA including products with Breakthrough or PRIME designation. We develop open and trusting 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.
Since 2001, Slough development has transferred more than 500 customer or Lonza developed processes into cGMP manufacturing for small, mid or large scale at all product lifecycle stages.

Process Optimization of the Lonza Platform Process – a case study on how we have used DoE in cell culture development and process optimization.

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Technologies and Products

For the last 30 years our GS Gene Expression System® has been continuously improved for robust technical performance. It 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.