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 aseptic manufacturing and sterile filling solutions and strategies for your molecule’s unique needs and challenges will enable success in early development, late-phase, and commercial manufacturing.
In 2022, we produced over 172 million sterile liquid and lyo vials
Thermo Fisher Scientific was the leading CMO of Parenteral Non-NME NDA approvals from 2013-2022, having 10 (11% market share) Parenteral/Injectables Non-NME NDA approvals from 2013-2022.1
From 2013 to 2022, Thermo Fisher Scientific has received more NDA/BLA approvals than the next 2 CMOs combined.1
In 2022, we produced over 172 million sterile liquid and lyo vials
Thermo Fisher Scientific was the leading CMO of Parenteral Non-NME NDA approvals from 2013-2022, having 10 (11% market share) Parenteral/Injectables Non-NME NDA approvals from 2013-2022.1
From 2013 to 2022, Thermo Fisher Scientific has received more NDA/BLA approvals than the next 2 CMOs combined.1
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 molecule and your process.
Learn more about our sterile formulation development services for drug substances including:
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 molecule’s needs:
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:
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:
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.
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:
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 >>
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: