Aseptic Manufacturing and Sterile Fill Finish Services
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 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.
172 million
In 2022, we produced over 172 million sterile liquid and lyo vials
Leading CMO
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
NDA/BLA approvals
From 2013 to 2022, Thermo Fisher Scientific has received more NDA/BLA approvals than the next 2 CMOs combined.1
172 million
In 2022, we produced over 172 million sterile liquid and lyo vials
Leading CMO
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
NDA/BLA approvals
From 2013 to 2022, Thermo Fisher Scientific has received more NDA/BLA approvals than the next 2 CMOs combined.1
Aseptic manufacturing and fill finish 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 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:
- Liquid filled vials
- Lyophilized vials
- Extensive range of vial sizes including ISO standard
- Pre-filled syringes and cartridges
Helpful resources
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
View references