Biologics Product Development

Preformulation Screening

With speed and efficiency, evaluate the properties of your biologic for a clear understanding of the path to Phase I clinical studies and beyond. Patheon, a part of Thermo Fisher Scientific, gives you access to the full breadth of advanced analytical technologies and preformulation services.

  • Chemical purity analysis
  • Physicochemical properties
  • Solid form definition and analysis
  • Molecular structure analysis
  • Excipient compatibility testing
  • Amorphous vs. crystalline solid state testing
  • Aqueous and solvent solubility
  • Solution and solid state stability
  • Vehicle screening for ADME and toxicity

Working with us at this early phase opens the door to a partnership that can take you all the way to commercial supply. Fully integrated services that deliver speed, flexibility and a streamlined supply chain. One partner, one team, one seamless solution customized to your exact needs.

Formulation Development

Get your discovery to the proof of concept milestone with speed and efficiency while laying a firm foundation for future commercial success. We have helped clients receive more NDA approvals than any other CMO.* By pairing this experience with a full range of analytical, formulation and dosage form technologies and solutions, we will tailor a lean drug development program precisely suited to your molecule and business. One that will accelerate your project to first-in-human studies, and beyond when fully integrated with our comprehensive commercial supply and drug substance services. 

*Source: PharmSource ® CMO Scorecard, March 2016.

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 you need.

  • 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.

Manufacturing Process Development

Build quality and robust repeatability into your manufacturing process. Do it during early phases to accelerate through later phases and into commercial production upon approval. Because our capabilities span the full breadth and depth of the biopharmaceutical development life cycle, because we have experience at every stage, we know what your process needs to succeed today and tomorrow. With us, you’ll get a process that is reliable, efficient and built to deliver repeatable quality when you bring your product to market.

Dosage Forms

Every biologic offers unique technical challenges, just as every biopharmaceutical company has specific business requirements. The more options you have available, the more precisely you will be able to meet these needs. This is why we offer such an expansive range of choices in sterile dosage forms, technologies and development services.

Access extensive sterile pharmaceutical product development capabilities, including terminal sterilization, aseptic processes and world-class expertise in lyophilization. You’ll also have access to a state-of-the-art capabilities for prefilled syringes and cartridges.

  • Liquid Small Volume Parenterals (SVP): Choose from a wide range of vial forms and sizes to achieve exactly the right solution for your project.
  • Liquid Large Volume Parenterals (LVP): Available in a broad array of forms and sizes, this is often the dosage form of choice to efficiently acheive proof of concept.
  • Lyophilized Vials: Access capabilities from 2 mm vial size up to the 100 mm in the same facility, in both North America and Europe. This affords you the speed and efficiency of seamless scale-up with precise control of process conditions for consistency at any phase or scale.
  • Prefilled Syringes and Cartridges: Ready-to-use dosage formats that enable self administration of parenterals that once required a clinical visit. As the healthcare industry seeks to move treatments out of the clinic, we are investing in the capabilities that will keep you ahead in the evolving marketplace.

Our sterile capabilities also include process development and manufacturing of biologic drug substances at all scales from clinical to global commercial. With us as your single-source partner, you’ll be able to bring your large molecule discoveries to market with more speed and efficiency than ever before.

Clinical Batch Manufacturing

High-quality clinical trial materials to support your pursuit of regulatory approval. Fit for purpose formulations for Phase I and II studies. A comprehensive range of finished dosage forms for Phase IIb and III studies. Patheon, a part of Thermo Fisher Scientific, has decades of experience and an inspection record that is second to none. Our reliable quality is further proven by our exceptional Right First Time/On-Time delivery track record.

As your project progresses through clinical trials, we have the full range of services to respond to your evolving needs with speed and flexibility.

  • cGMP manufacturing at all scales
  • Fit for purpose formulations for early phases
  • Full range of sterile finished dosage forms
  • Materials for dose escalation studies
  • Registration batches
  • Quality by Design process development
  • Full analytical support and stability testing
  • CMC documentation for regulatory submissions

Clinical trial material manufacturing is only one of our fully integrated pharmaceutical development services. Our facilities are designed with a commonality of equipment from clinical batch to commercial for seamless scale-up. Patheon OneSource ™ aligns development of your drug substance and drug product for the most efficient path to market, taking months off your development timeline.

Do you want to learn more?

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