Sterile drug product development

Solve complex challenges throughout your product lifecycle

The rapid growth of sterile drug product due to the rise in biosimilars, mRNA, and other prevalent therapies has resulted in the need for capacity and innovative solutions within development and manufacturing. Navigating a complex regulatory environment, analytical data, process development and optimization, and on-time delivery are all vital to the success of your sterile drug product. Our flexible solutions and strategies for your large molecule’s unique needs and challenges will enable success in early development, late-phase, and commercial manufacturing.

169 million

We produced 169 million sterile liquid and lyo vials in 2020

Leading CMO

Thermo Fisher Scientific was the leading CMO of Parenteral/Injectables NME and Non-NME NDA approvals from 2011-20201

10 years

In the past 10 years, Pharma Services has received as many NDA approvals as the next three CDMOs combined, making us a trusted partner for your project

169 million

We produced 169 million sterile liquid and lyo vials in 2020

Leading CMO

Thermo Fisher Scientific was the leading CMO of Parenteral/Injectables NME and Non-NME NDA approvals from 2011-20201

10 years

In the past 10 years, Pharma Services has received as many NDA approvals as the next three CDMOs combined, making us a trusted partner for your project


Steriles solutions and capabilities

Getting formulation right from the start of early development can help save time and money as you advance through each phase and on to commercialization. Our early development formulation experts and scientists are here to support every step of your project. Gain access to an integrated drug formulation program that is tailored to your large molecule and your process.

Helpful resources 

Gain access to a broad range of dosage forms to meet your molecule’s specific needs. As we work with you to build your program, we are focused on providing speed, flexibility, and efficiency to accelerate your molecule’s journey to first-in-human (FIH) studies.

We understand the unique set of challenges that arise with traditional or niche indications in drug development for steriles. We offer a broad range of dosage forms to meet your large molecule’s needs:

  • Liquid filled vials 
  • Lyophilized vials 
  • Extensive range of vial sizes including ISO standard 
  • Pre-filled syringes and cartridges 

Building out a robust, agile, and flexible process will set you up for long term success as you scale up and will help you achieve high quality results and sustainability within your product’s lifecycle. Our industry experts have the experience to develop an optimal process that is tailored to your needs, including:

  • Lyo-cycle process development and optimization
  •  Manufacturing process development
  • Studies: 
    • Mixing and pump-shearing 
    • Holding time 
    • Freeze-thaw 
    • Scalability product contact part compatibility 
    • Proven Acceptable Ranges (PAR) 
    • International Council for Humanization (ICH) stability
    • Shipping container 
    • Component compatibility testing
  • Cleaning validation 
  • Sterilization cycle development and validation 

Scaling to commercial manufacturing can be arduous as you try to balance speed, regulatory needs, and the supply chain. Patheon pharma services offers experience, reliability, and a broad range of sterile fill/finish commercial solutions that enable you to:

  • Navigate a complex regulatory environment at a global scale 
  • Get to market quicker 
  • Execute tech transfers with speed 
  • Ensure a robust supply chain within a global network 

Helpful resources 

Whether it’s for scaling up or moving to another facility, technology transfers are part of the normal course of business. Learn how our tech transfers ensure transparency and efficiency.

In the past 10 years, we have received as many NDA approvals as the next three CDMOs combined, and more than third of our commercial manufacturing product launches originate from our formulation and development programs.

Helpful resources 

We offer experience, reliability, and a broad range of sterile fill/finish commercial capabilities. We have an unrivaled record of sterile drug product commercialization success for our clients. Leveraging our commercial production and clinical trials solutions will give you extensive access to global technical experts, scale, capability, global regulatory insights, and transportation. Global network and solutions include the following:

  • Clinical trial packaging and storage 
  • Clinical supply optimization 
  • Clinical label 
  • Cold chain storage and logistics 
  • Distribution and logistics 
  • Global clinical ancillary management 

Our Patheon™ Quick to Clinic™ programs rapidly accelerate your molecule to FIH studies using minimal amounts of your valuable drug substance. Learn more about our programs >> 

Helpful resources 

Patheon pharma services is the global standard for quality and assurance for cold chain solutions. With an expansive network and facilities strategically located across the globe, we provide comprehensive site-to-site connectivity with dependable storage, packaging, labeling, and shipment capabilities. We maintain product integrity and quality at every point of transfer from collection to shipping or distribution.

Our reliable infrastructure offer enables us to help you:

  • Ship single patient units to any clinical site around the world 
  • Transport cellular therapies and biologics, including vaccines and monoclonal antibodies 
  • Access custom liquid nitrogen equipped vehicles 
  • Access a fleet of validated dry shippers 
  • Transport customer-owned freezers, refrigerators, and liquid nitrogen tanks from one facility to another 

Helpful resources 


View references
1. GlobalData: New Drug Approvals and Their Contract Manufacture – 2021 Edition