Biologics Dosage Forms
Access extensive sterile pharmaceutical manufacturing capabilities and scales, including terminal sterilization, aseptic processes and world-class expertise in lyophilization. With Patheon, a part of Thermo Fisher Scientific, you’ll also have access to a state-of-the-art commercial-scale cGMP manufacturing suite 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, we often utilize this dose form to help clients efficiently achieve proof of concept.
- Lyophilized Vials:
Benefit from the speed and efficiency of having access to seamless scale-up from development to commercial manufacturing. This is possible because the equipment capabilities at our facilities in North America and Europe range from 2 mm vials up to 100 mm vials, enabling precise control of process conditions for consistency at any phase or scale.
- Prefilled Syringes & Cartridges: Ready-to-use dosage formats that enable self administration of parenterals which once required a clinical visit. As the healthcare industry seeks to move treatments into the home, we are investing in 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.
Process Validation and Tech Transfer
A complete process validation in accordance with regulatory and cGMP guidelines is essential for the establishment of a reliable high-quality commercial supply of your biologic drug product.
- Process validation with critical parameters
- Validation of analytical assays
- Hold time studies
- Stability studies at required ICH conditions
- Container shipment studies
- Release testing
- CMC documentation in CTD format
While technology transfers are commonly viewed as part of the normal course of business, we see them as an opportunity to use our integration and efficiency to give clients a strategic and financial advantage. Even when your transfer is urgent, our teams can execute it quickly and effectively to minimize interruption to product supply.
In 2016, we successfully completed the Technology Transfer of 111 commercial scale products. In all cases, we are driven by your deadlines, flexible in our approach, and determined to get your tech transfer right the first time every time. It is with this approach we won the European Outsourcing Award for Most Effective Technical Transfer in 2008, 2010, 2011 and 2012.
Repeatable high quality delivered by exceptional analytical services teams. The speed and efficiency of being in-house at every sterile dose manufacturing facility. Fully equipped cGMP labs providing you with comprehensive project support.
- In-process control production support
- Release testing
- Stability testing for various ICH climatic zones
- Genotox studies
- PAR studies
- IND/IMPD dossier support
Work with us and you’ll always have access to the full breadth of our analytical services and capabilities. Know-how grounded in the experience of manufacturing hundreds of products, and scientifically sound data for your regulatory submissions.
You’ll feel confident in the quality of your product and processes because of the high quality of the analytical data they’ll be built upon. No matter what the demands of your project.
Commercial Batch Manufacturing
Patheon, a part of Thermo Fisher Scientific, is a global leader in contract pharmaceutical manufacturing. Our work has encompassed more than one third of all outsourced biopharmaceutical NMEs globally – That’s more than twice as many than any other CDMO.
With us you’ll have access to extensive commercial capabilities, scale and capacity; the full spectrum of sterile dosage forms; and a global network of fully integrated world-class facilities – all approved by international regulatory agencies, and all with Right First Time/On-Time track records that are second to none.
You’ll have a partner whose groundbreaking custom manufacturing suites and streamlined supply chain solutions are transforming the industry. Over 40 years, quality and innovation have earned us the trust of the industry:
- All of the top 20 pharmaceutical companies*
- 15 of the top 20 specialty pharmaceutical companies*
- 18 of the top 20 biotech companies*
In FY2015 we produced more than 700 products for delivery to more than 70 countries. This includes the development or manufacturing of 27 of the top 100 pharmaceutical Rx products of 2015.
Source: Development and commercial client list 2015; EvaluatePharma® WW Prescription (Rx) 2015 sales data.
High-capacity cGMP primary and secondary packaging for sterile dosage forms for both long-term and short-term needs. We can deliver a finished biologic drug product approved for distribution around the world, and do so for multiple markets from a single batch. Plus you'll have access to expert guidance in stability, safety and USP testing, as well as component specification.
We are a flexible and efficient alternative to specialized vendors. With the same level of expertise and quality, you can directly align your packaging with your product manufacturing to streamline your supply chain. Generate even more efficiency and speed to market by also tying in the development and manufacture of your large molecule drug substance.
Custom Manufacturing Suites
We are committed to providing clients with solutions precisely tailored to meet the unique requirements of their product and business. That may mean collaborating with you on the design, construction, management and operation of a fully equipped, state-of-the-art, cGMP manufacturing suite within one of our facilities.
This unique alternative approach enables you to benefit from our expertise in facility design, construction, equipment selection, process development and technology transfers. You’ll have a completely customized, dedicated solution that will ensure you have the commercial biologic drug product supply you need to succeed.