Develop and optimize your process for clinical and commercial API production at state-of-the-art facilities in Europe and North America. Access the full range of standard process development technologies as well as high throughput experimentation capabilities. Work directly with experts who possess many years of experience. Our core competences include:
- Route scouting
- Process development
- Clinical supply manufacturing
- Tech transfer and scale-up of new and existing processes
- Improvement of existing processes
- Expertise with difficult to manufacture APIs
- High potency compounds and controlled substances
- Comprehensive analytical services
Scale-up will include risk assessment and proven acceptable range (PAR) studies, as well as validation of analytical methods and the manufacturing process. If needed, our QA/regulatory compliance team can provide data and support for the CMC portion of your submission.
Clinical Batch Manufacturing
Your early-stage clinical supply of API will be produced at state-of-the-art facilities in Europe and North America. You’ll work with a team of top-tier experts employing a full range of technologies and analytical services to deliver exceptional yields and quality. For late-stage trials and beyond, your supply of small molecule drug substance will be manufactured at a cGMP commercial production facility on equipment complimentary to that used at earlier stages for seamless scale-up and an abbreviated tech transfer process. Our facilities offer everything you need:
- Sites throughout Europe and North America
- Capacity for 1 kg to thousands of metric tons
- Comprehensive array of technologies, services and solutions
- Flexible, seamlessly scalable process
- Access to a streamlined end-to-end supply chain
- Peerless quality systems and successful first batch track record
- Full regulatory support with CMC documentation
Patheon, a part of Thermo Fisher Scientific, offers you the means to streamline and coordinate every aspect of developing a successful pharmaceutical product. By partnering with us you will unlock the potential to accelerate development and simplify your supply chain.
Achieve repeatable high quality and robust process design at every phase of your small molecule API pharmaceutical development projects with access to a comprehensive array of analytical services.
- Physical and chemical definition and analysis
- Process development and validation
- Analytical development and validation
- Impurity tracking
- In-process production support
- Stability testing for various ICH climatic zones
- PAR studies
We have cGMP labs staffed by highly experienced teams within each of our manufacturing and development sites. Gain the scientifically sound data you need for regulatory submissions and to guide your next steps. When those next steps include us, we can use the results of your API analytical activities in the development of your drug product, gaining you significant time and cost efficiency. Get high-quality analytical data for high-quality products, processes and business decisions.
Process Validation and Tech Transfer
In clinical phases and as part of the establishment of your commercial supply of API, Patheon, a part of Thermo Fisher Scientific, provides a complete validation package according to regulatory and cGMP guidelines. With us, you’ll have everything you need to ensure the reliability of your supply with consistent high quality.
- Process validation with critical parameters
- Validation of analytical assays
- Stability studies
- Container shipment studies
- Release testing
- CMC documentation in CTD format
We see tech transfers as an opportunity to use our integration and efficiency to give you a strategic and financial advantage. Technology transfers, for scale-up or to move a project between facilities, are part of our normal course of business. Even when the transfer is urgent, We can execute it quickly and effectively to get your project back on track and preserve the supply of product. In all cases, we are driven by your deadlines, flexible in our approach and determined to get it right the first time every time.
In 2008, 2010, 2011 and again in 2012, The European Outsourcing Awards recognized Patheon for executing the most effective scale-up and technology transfer.
Commercial Batch Manufacturing
Commercial API manufacturing under full cGMP conditions with speed, efficiency and exceptional quality. Flexibility to adapt to changes in your market and mission. We will never stop working to optimize your process to increase outputs while reducing timelines. We are continuously making investments in capacity, infrastructure and technology.
- Global Capacity: Industrial-scale facilities in North America and Europe, some with total capacity in excess of 700,000 L with reactors as large as 16,000 L.
- Many Options: An exceptionally broad range of capabilities at any scale plus expertise in complex chemistries, to manufacture APIs other CMOs simply cannot.
- Highly Regulated Compounds: Infrastructure, safety procedures and regulatory approvals to work with controlled substances and highly potent compounds.
- Relentless Innovation: Microreactor flow chemistry, advanced catalysis, proprietary process intensification technologies – we push boundaries to give you an edge.
- Reliable Quality: Our exceptional regulatory track record and Right First Time/On-Time performance have made us a leader in the industry for quality.
- Spotless Reputation: We have earned the trust of the top 20 pharmaceutical companies in the world. We supply API for more than 100 commercial products.
With Patheon, a part of Thermo Fisher Scientific, you can align the development and manufacturing of your API with that of your finished dosage form to simplify your supply chain and maximize value. To lower your cost of goods while maintaining the highest standards of quality. To earn your business year after year with hard work and innovation.
The “right solution” is the one that most directly addresses the specific needs of your molecule, timeline and budget. This is true of everything we do, and vividly demonstrated by our unique solutions.
These high quality products and customizable solutions bring together core capabilities and advanced technologies to overcome your most critical challenges with maximum speed, efficiency, quality and value in ways only possible with our team.
- APIs and Intermediates
- Innovative Technologies
- Microreactor Flow Chemistry
- Advanced Catalysis
APIs and Intermediates
High-quality active pharmaceutical ingredients (APIs) and intermediates made by Patheon, a part of Thermo Fisher Scientific, in the same facilities, and to the same stringent standards, as our custom manufactured projects. Common building blocks for pharmaceuticals made with an uncommon level of precision. Another way we help you simplify your supply chain.
Companies that understand the difference between price and value know pharmaceuticals can only be as good as their chemical components. Rather than exposing your project to the risks of commoditized materials, source from a reputable partner you know. Whether you need a kilo for an in-house project or barrel after barrel for a project with Patheon, you can rely upon this portfolio of APIs and intermediates to make your products their best.
Access a vast range of small molecule API capabilities in Europe and North America. All the chemistries you expect plus many innovative technologies. Unique solutions that open the door to groundbreaking reactions, processes and drug substances that are otherwise impossible.
Microreactor Flow Chemistry
Get the efficiency, flexibility and scalability of the lab of tomorrow made reliable at commercial scale today. Microreactor flow chemistry is a continuous process of small reactions. The result is faster, more efficient, easier to control reactions capable of 20% higher yields. The exact same process is used for pilot batches and production runs, simplifying scale-up.
Small reactions enable extremely harsh conditions that would be prohibitively dangerous at commercial scale using traditional equipment. With Patheon microreactor flow chemistry you are free to explore new process designs with novel process windows to unlock new reactions. Only Patheon, a part of Thermo Fisher Scientific, has the years of hands-on experience to guide you through the parameters of what is technically and financially feasible.
Leverage this high-yielding, environmentally friendly reduction reaction at any scale from 1 g – 1,000 metric tons/year. Choose from an exceptionally wide selection of process technologies and reaction systems. Consistently achieve atom economy of near 100%. Control and change the oxidation state of organic compounds in a selective, safe and efficient reaction – a key capability in organic synthesis.
Today’s discoveries can require complex, multi-step chemical synthesis, which conflicts with pressure to prove viability quickly or move on. We make more of these discoveries feasible with advanced catalysis technologies that can reduce timelines from years to months. You’ll have access to interdisciplinary route scouting expertise, 2,000+ enzymes, proprietary biocatalytic processes and experience with large-scale complex processes that development-only labs do not. Everything you need to pursue the potential of more of your discoveries.
Create completely unique products by combining proprietary process technologies, polymer science, advanced synthesis and large-scale cGMP expertise. The specialized equipment and distinctive properties of polymers are unfamiliar to those focused on conventional pharmaceutical syntheses. The volumes are huge and the challenge to cGMP analytics is formidable. After two decades, we still stand apart in mastery of this technology – as do the pharmaceuticals we make with it.