Drug Substance

Process Development

Comprehensive upstream process development capabilities and a commitment to innovation, quality and service, make us the ideal partner for the process development of your mammalian cell culture projects. Our fully integrated global network includes cGMP facilities across Europe, North America and Australia. Our expertise spans multiple commercial cell lines: CHO, myeloma, hybridoma and PER.C6® as well as cGMP cell banking.

  • Batches at all scales
  • Process development and validation
  • Design of Experiment studies
  • Scale-up and tech transfer

You’ll be assigned a project manager who will serve as your main point of contact. You’ll also have a cross-functional team dedicated to designing a process that meets the needs of your discovery and your business. 

Flexible solutions are custom built from comprehensive technical capabilities in fed-batch and perfusion processes. Patheon, a part of Thermo Fisher Scientific, also works with high density mammalian cell culture technologies including our proprietary XD™ and Rhobust™ technologies.

We also understand the unique needs of consultants and offer custom, flexible solutions that cater to your clients’ needs.

Clinical Batch Manufacturing

World-class facilities in Europe, North America and Australia, offer the flexibility to adapt to changes in the market and product development strategy. Upon completion of preclinical development, our award-winning tech transfer team will move your project to a cGMP facility for scale-up and production of your clinical materials. It’s an approach that pays off in two ways: Using a non-GMP lab for initial screening activities accelerates your path to market. The protocols of transferring into cGMP serve to expose opportunities to improve your process.

Analytical Services

World-class analytical capabilities engaged at every phase of development. Rapid identification and characterization of your recombinant protein or antibody. Development and implementation of cGMP methodologies. Generation of data for regulatory submissions.

Our breadth of analytical services and capabilities ensures that you always have access to the tools and know-how.

  • HPLC /UPLC based methods
  • Glycan profiling
  • ELISAs for product and impurities assessment
  • Gel and capillary based electrophoresis
  • Gel and capillary based isoelectric focusing
  • Residual DNA detection
  • Cell-based assays
  • Immunologic and colorimetric assays
  • Mass spectrometry
  • Analytical method validation
  • Stability testing for various ICH climatic zones

Get the high-quality analytical data you need to maximize the quality of your product and processes, and make critical decisions with confidence.

Process Validation and Tech Transfer

In late clinical phases, and as part of the establishment of your commercial supply, we provide a complete validation package according to regulatory and cGMP guidelines.

  • Process validation with critical parameters
  • Validation of analytical assays
  • Virus validation of the downstream process
  • Resin re-use and hold time studies
  • Stability studies for various ICH climatic zones
  • Container shipment studies
  • Release testing
  • CMC documentation in CTD format

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

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.

Commercial Batch Manufacturing

Commercial manufacturing under full cGMP conditions with speed, efficiency and exceptional quality, plus flexibility to adapt to changes in your market and mission.

There is no such thing as good enough. We will never stop working to optimize and intensify your process to increase outputs and reduce timelines and capital expenditure. We are continuously making investments in capacity, infrastructure and technology. Our goal is to lower your cost of goods while maintaining the highest standards of quality. And to earn your business year after year with hard work and innovation.

2014 ISPE Facility of the Year for Process Innovation

From its innovative business structure to its state-of-the-art technologies, our cGMP facility in Brisbane, Australia is a model for the future of biomanufacturing. It offers 8,000 square meters (86,000 square feet) of clinical and commercial manufacturing. Now companies in Australia, and from around the world, have access to exceptional biologic expertise and a portfolio of proprietary technologies in a uniquely business-friendly environment. The Australian Taxation Office is offering tax rebates up to 45% for the R&D of eligible products. Also, the Biopharmaceutical Development Fund from BioParmaceuticals Australia offers grants up to $250,000 to eligible companies. 

Do you want to learn more?

We look forward to learning about your specific needs, please contact us.