Small Molecule (API) Commercial Manufacturing

Patheon, part of Thermo Fisher Scientific, offers commercial API manufacturing under full cGMP conditions with speed, efficiency and exceptional quality. We bring 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, including:

  • Global capacity: Commercial manufacturing facilities in North America and Europe, with total capacity in excess of 700,000 L, and with reactors up to 16,000 L.
  • Technical Expertise: An exceptionally broad range of technical capabilities plus expertise in complex chemistries, to manufacture APIs (active pharmaceutical ingredients)
  • High containment and regulatory compliance: Infrastructure, safety procedures and regulatory approvals to work with controlled substances and highly potent compounds.
  • Continuous innovation: With “continuous flow” processes in microreactors, advanced catalysis, proprietary process intensification technologies, we push boundaries to give you an edge.
  • Commitment to 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.

Commercial Batch Manufacturing

With Thermo Fisher Scientific, you can also align the development and manufacturing of your API with that of your finished dosage form to simplify your supply chain and maximize value. Our goal is to streamline and accelerate your supply chain while maintaining the highest standards of quality – and to earn your business year after year with hard work and innovation. A range of technologies are available within our commercial manufacturing network:

  • “Continuous flow” processes in microreactors: Only Thermo Fisher Scientific can deliver today the efficiency, flexibility and scalability of the lab of tomorrow with reliability at commercial scale.
  • Advanced catalysis: Bring feasibility to more of your most challenging discoveries and most complex processes with access to interdisciplinary route scouting, proprietary biocatalytic processes and scale-up timelines reduced from years to months.
  • Polymer APIs: We can combine proprietary process technologies, deep polymer science knowledge and large-scale cGMP production expertise to deliver these unique products.
  • Cryogenic manufacturing: Access low-temperature capabilities down to -85 °C in 200 L – 2,000 L reactors.
  • High-pressure manufacturing: Take advantage of 1,000 psi high-pressure processing, including hydrogenation, at 200 L and 2,000 L scales.
  • Highly potent compounds: Put your trust in our global network of facilities featuring the latest high containment infrastructure.
  • Controlled substances: Gain access to facilities that are fully licensed by the DEA.

Innovative Manufacturing Technologies

Access our vast range of small molecule API capabilities in Europe and North America, with all the chemistries you expect plus many innovative technologies. We can provide unique solutions that open the door to groundbreaking reactions, processes and drug substances that would otherwise be impossible.

Additionally, we have a continuous manufacturing line now fully functional in our Greenville, NC site.

“Continuous Flow” Processes in Microreactors

We run “continuous flow” processes in microreactors – on commercial scale. This results in faster, more efficient, easier-to-control reactions capable of 20 percent higher yields. Exactly the same process is used for pilot batches and production runs, simplifying scale-up.

Reactions in microreactors can take place under extremely harsh conditions that would be prohibitively dangerous at commercial scale using traditional equipment. With our continuous flow processes in microreactors, you are free to explore new process designs with novel process windows to unlock new reactions. Only Thermo Fisher Scientific has the years of hands-on experience to guide you through the parameters of what is technically and financially feasible.

Hydrogenation

Leverage this high-yielding, environmentally friendly reduction reaction at any scale from 1 g to hundreds of metric tons/year. With us as your partner, you can choose from an exceptionally wide selection of process technologies and reaction systems, consistently achieving atom economy of near 100%. You’ll be able to control and change the oxidation state of organic compounds in a selective, safe and efficient reaction – a key capability in organic synthesis.

Advanced Catalysis

Today’s discoveries can require complex, multi-step chemical synthesis, which conflicts with the need 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, proprietary biocatalytic processes and experience with large-scale complex processes that development-only labs do not. We can provide everything you need to pursue the potential of more of your discoveries.

Polymers

We can work with you to 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.

Commercial Products

High-quality APIs and intermediates are made in the same facilities, and to the same stringent standards, as our custom manufacturing projects. These are common building blocks for pharmaceuticals made with an uncommon level of precision.

Companies that understand the difference between price and value know that pharmaceuticals will only be as good as their chemical components. Rather than exposing your project to the risks of commoditized materials, source from a reputable and trusted partner. Whether you need a kilo for an in-house project or metric tons for a commercial project, with us, you can rely upon this portfolio of APIs and intermediates to make your products their best, and simplify your supply chain. Our portfolio includes:

  • NeoBr – CAS RN: 114-80-7 – Neostigmine bromide
  • NeoMS – CAS RN: 51-60-5 – Neostigmine methylsulfate
  • P1DR – CAS RN: 108-73-6 – Phloroglucinol anhydrous
  • P1B – CAS RN: 6099-90-7 – Phloroglucinol dihydrate
  • PyrBr – CAS RN: 101-26-8 – Pyridostigmine bromide
  • SSD – CAS RN: 22199-08-2 – Silver sulfadiazine
  • CAS RN: 2524-64-3 – Diphenylchlorophosphate
  • CAS RN: 90315-82-5 – (R)-2-Hydroxy-4-phenylbutanoic acid ethyl ester
  • TMB Milled Flakes – CAS RN: 621-23-8 – 1,3,5-Trimethoxybenzene milled flakes
  • CREA – CAS RN: 60-27-5 – Creatinine
  • GF – CAS RN: 5464-28-8/4740-78-7- Glycerol formal—EKT
  • CAS RN: 608-25-3 Glycerol formal—EKT 2-Methylresorcinol
  • Moclobemide – CAS RN: 71320-77-9
  • Flucytosine – CAS RN: 2022-85-7 – CAS RN:96829-58-2
  • Acitretin – CAS RN: 55079-83-9
  • Colesevelam – CAS RN: 182815-44-7
  • Clodronate disodium – CAS RN: 22560-50-5

Innovative Business Solutions

Thermo Fisher Scientific is dedicated to providing clients with solutions precisely tailored to meet the unique requirements of their products 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. You can benefit from our expertise in facility design, construction, equipment selection, process development and technical transfers to ensure you have the commercial product supply you need to succeed.

Our Shell Concept allows us to create a custom facility for your specific process needs. The capacity is all yours to flex as your demand requires.

Speak with one of our manufacturing experts about your project.