Benefit from our proven technical transfer and process validation expertise

At Patheon, part of Thermo Fisher Scientific, we pride ourselves on our creating flexible manufacturing options for our clients. We understand the uncertainty associated with forecasting demand. We think strategically to offer biomanufacturing options that meet the unique needs of your molecule. We can work with your cell lines. Our contracts are individualized to meet your requirements and we do not charge royalties. And our reputation is built on transferring complex molecules both in and out of our company.

We apply our deep Process Development skills to dramatically increase the batch yield and significantly reduce processing time for your molecule. Applying Design of Experiment (DoE) methodology to both Upstream and Downstream Processing, we define the CPPs and CQAs that enable robust processes, maximize yields, and optimize throughput. For Upstream Processing, we utilize the Sartorius ambr® 15 and 250 systems as well as 10 L single-use bioreactors to define optimal feed and processing conditions.

 You’ll have access to everything you need to ensure the reliability of your supply and consistent high quality, including:

We see tech transfers as an opportunity to use our integration and efficiency to give our clients a strategic and financial advantage. Technology transfers, for scale-up or to move a project between facilities, are part of the normal course of business. But even when the transfer is urgent, our teams can execute it quickly and effectively to get your project back on track and preserve the supply of product. In all cases, we are driven by your deadlines, flexible in our approach and determined to get it right the first time, every time.

 

Complete Validation

As part of the establishment of your commercial supply of biologic drug substance, we provide a complete validation package according to regulatory and cGMP guidelines, including:

  • Process validation with critical parameters
  • Validation of analytical assays
  • Release testing
  • ICH stability testing
  • Container shipment studies
  • CMC documentation in CTD format

Read our Complete Development & Manufacturing Overview Brochure