Patheon

End-to-end, fully compliant clinical manufacturing services for biotech and pharma drug developers conducting clinical trials, including microdosing, placebo manufacturing, and blinding.

Investigational product packaging, labeling, and distribution services supporting clinical trials with ambient, refrigerated, and frozen capabilities.

Comprehensive clinical trial packaging, labeling, storage, and distribution services provided at the Ahmedabad, India Special Economic Zone facility.

World-class total transportation management, storage, and distribution services to protect product integrity throughout the supply chain or cold chain.

Clinical Supply Chain Optimization Services focus on streamlining and optimizing your supply chain using state-of-the-art tools and an extensive global network, overseeing strategy, planning, execution, and refinement.

Comprehensive suite of clinical trial supply chain capabilities including distribution, secondary packaging, returns, and destruction.

Comprehensive aseptic sterile fill-finish capabilities for clinical and commercial supply.

Efficient sterile drug manufacturing and development for injectable medicines supporting biologics, small molecules, and mRNA therapeutics from development through commercial manufacturing.

An integrated, FDA-inspected facility in Cork, Ireland offering small molecule API process development, scale-up, and commercial manufacturing, with specialized capabilities for highly potent APIs.

Comprehensive development and commercial manufacturing services for solid oral dosage forms including tablets and capsules, featuring high potency capabilities and specialized processing in Toronto, Ontario.

Flexible drug substance manufacturing site offering highly potent compound handling, process development and scale up, and large-scale and mid-scale API production.

Global network of facilities providing development, manufacturing, and commercialization services for highly potent compounds.

Small molecule API manufacturing services with reactors ranging from 30 L up to 16 m3, comprehensive analytical services, and chemistry expertise in Europe and the United States.

Viral vector manufacturing, testing, and process development services supporting phase III and commercial supply of AAV, Lenti, Adeno, HSV, and Retro.

Integrated lentiviral vector CDMO services covering early process development through commercial GMP manufacturing, supporting CAR-T therapies and gene therapy applications.

A unified, one-team approach that seamlessly integrates API development and product manufacturing to simplify complexity and reduce risk.

A comprehensive range of pharmaceutical development and manufacturing services spanning all drug development phases, offering an end-to-end approach for biotechnology and pharmaceutical companies.

Translational services approach to reduce risk, speed up drug development, and seamlessly transition cell and gene therapy products to cGMP manufacturing.

Flexible drug substance manufacturing site offering highly potent compound handling, process development and scale-up, with large-scale and mid-scale API production capabilities.

End-to-end oral solid dose (OSD) manufacturing and development services at the Bourgoin, France facility, handling quantities from preclinical phases to commercial production.

Comprehensive viral vector CDMO services offering a full range of capabilities for the development and commercialization of viral vectors and gene therapy-based vaccines, from early discovery to commercial manufacturing.

Upstream and downstream process development with platforms to manage multiple projects simultaneously, tailored to fit various cell lines and molecules from Phase I to commercialization.

mRNA development and manufacturing services for advanced therapeutics and vaccines.

Integrated sterile liquid and lyophilized product development and commercial manufacturing services located at the Ferentino, Italy facility, including high potency products and large volume parenterals (LVP).

Establishing the best synthetic route for your molecule to ensure reliable supply throughout your product's lifecycle.

API development services and small scale API manufacturing providing rapid scale up and chemical production of intermediates and APIs for Phase I and Phase II clinical trials under cGMP / ISO conditions.

Robust process control strategy including process characterization, validation risk assessments, and single-use technology scale production up to 5,000 L.

End-to-end solutions that connect clinical trial treatments directly with patients to improve convenience and study retention.

Specializes in process development and chemical production of intermediates and APIs for toxicology, pre-clinical and clinical supply under both non-cGMP and cGMP conditions.

Tech transfers for scale-up or moving projects between facilities to give a strategic and financial advantage.

Full-service cell therapy process and analytical development capabilities and clinical and commercial cGMP manufacturing services located in the San Francisco Bay Area.

Comprehensive development and manufacturing services for Adeno-associated virus (AAV) vectors across multiple serotypes utilizing state-of-the-art technologies including triple transfection in adherent and suspension cell cultures as well as producer cell line based viral production.

Comprehensive contract development and manufacturing services for solid oral dosage forms, controlled substances, and specialized release technologies at the Cincinnati, Ohio facility.

Comprehensive CDMO services supporting autologous and allogeneic cell therapies with modification processes across various cell types including T-cells, NK cells, iPSCs, MSCs, APCs, and hESCs.

Commercial drug substance (API) and drug product manufacturing, packaging, and distribution services providing a streamlined approach to meet pharmaceutical manufacturing needs.

A flexible development solution for transfection-based lentiviral vector manufacturing that combines proven processes, established analytics, and configurable workflows.

A large, multipurpose pharmaceutical manufacturing and packaging campus providing solid dose form manufacturing/packaging and sterile dose manufacturing, filling and lyophilization of both biopharmaceuticals and small molecules.

Spray dried amorphous dispersions support the development of advanced drug formulations to ensure bioavailability, stability, and manufacturability.

Finding the most appropriate physical form for your API to impact downstream performance, bioavailability, and formulation.

Integrated biologics CDMO services from early development through clinical and commercial cGMP manufacturing, spanning mammalian cell line development, process development, and drug substance manufacturing.

Flucytosine API supplied as part of the Patheon portfolio of APIs and intermediates.

Particle size reduction solutions including milling and micronization for all stages of API development and commercial manufacture.

Clinical labeling featuring proprietary translation management, internal printing, and automated inspection software.

Moclobemide API supplied as part of the Patheon portfolio of APIs and intermediates.

Clodronate disodium API supplied as part of the Patheon portfolio of APIs and intermediates.

Acitretin API supplied as part of the Patheon portfolio of APIs and intermediates.

Colesevelam API supplied as part of the Patheon portfolio of APIs and intermediates.

State-of-the-art multipurpose biomanufacturing site providing flexible bioproduction technologies from pre-clinical process development through to large-scale commercial production.

Analytical method development, basic method validations, forced degradation, stability studies, and reference standard synthesis.

Phloroglucinol Dihydrate API supplied as part of the Patheon portfolio of APIs and intermediates.

An integrated platform combining biologics development, drug substance and drug product manufacturing services, clinical packaging, labeling, and distribution to accelerate timelines to IND/IMPD and Phase I clinical trials.

End-to-end digital supply chain platform for visibility and collaboration across the full product lifecycle, offering order management, process transparency, and automated forecasting.

Pyridostigmine Bromide API supplied as part of the Patheon portfolio of APIs and intermediates.

Creatinine API supplied as part of the Patheon portfolio of APIs and intermediates.

Silver Sulfadiazine API supplied as part of the Patheon portfolio of APIs and intermediates.

Phloroglucinol Anhydrous API supplied as part of the Patheon portfolio of APIs and intermediates.

Neostigmine Methylsulfate API supplied as part of the Patheon portfolio of APIs and intermediates.

Technology transfer services to facilitate the seamless transfer of pharmaceutical manufacturing processes from development to commercial-scale production.

Includes all Core services plus Thermo Fisher taking charge of detailed upfront planning and real-time study oversight, reducing supply chain risk.

Neostigmine Bromide API supplied as part of the Patheon portfolio of APIs and intermediates.

1,3,5-Trimethoxybenzene Milled Flakes intermediate supplied as part of the Patheon portfolio of APIs and intermediates.

Glycerol formal – EKT supplied as part of the Patheon portfolio of APIs and intermediates.

A biologics program development platform designed to take projects from DNA to final drug product, packed and labeled to begin Phase I clinical trials in as few as 8 months.

Scaled-down processes and qualifiable high-quality materials supporting early translational development.

Integrated mammalian cell line development, process development, GMP drug substance manufacturing, GMP sterile fill-finish, and clinical supply services designed to accelerate biologics programs from DNA to IND/IMPD submission and Phase I clinical trials.

Flexible integrated end-to-end solutions and technical expertise in commercial packaging combined with value-added supply chain and manufacturing services.

A clinical trial supply chain platform providing real-time data transparency, inventory and distribution management, web order entry, and sophisticated reporting for pharma and biotech companies.

Global network of biorepositories, integrated quality systems, and specialized supply chain solutions to store, process, and transport cell and gene therapies under ambient to cryogenic temperatures.

State-of-the-art sterile drug development and manufacturing facility in Singapore supporting rapid fill finish for vaccines and other therapeutics, featuring high-speed automated aseptic fill-finish lines for small and large molecules.

Robust in-house analytics for quality control, quality assurance, and analytical formulation sciences ensuring rigorous testing and compliance.

Comprehensive oral solid dose services encompassing phase-appropriate formulation development, process optimization, scale-up to commercial manufacturing, softgels, and continuous manufacturing.

State-of-the-art facility in Brisbane, Australia specializing in clinical and commercial manufacturing, and single-use biologics technology.

Cloud based, Clinical label-specific, validated translation and approval management system for online label order, text translation, and approval through label manufacturing.

Biologic manufacturing services at the Groningen, Netherlands site specializing in cGMP for clinical and commercial manufacturing, including mammalian cell culture manufacturing, scale up and cGMP manufacturing of recombinant proteins and monoclonal antibodies.

Clinical packaging solution featuring a protective carton design and tamper-evident sealing to ensure the safety of vials without requiring separate tamper-evident labels.

Regulatory-compliant movement, storage, and delivery of clinical supplies across diverse therapeutic areas globally.

Comprehensive analytical methods and drug substance/drug product formulation services for biologics, supporting therapeutic criteria from early phase to commercial manufacturing.

A suite of study services for seamlessly managing projects of varying complexity, including a mix of client and Thermo Fisher responsibilities.

Manufacture of cGMP cell banks on behalf of the biologics network using automated fillers.

Global consultative partnership and full suite of clinical ancillary management services with low-risk supply modeling and portfolio management.

Global assistance and real-time tracking to ensure prompt and complete delivery of clinical trial materials.

Supply and standard services with less complex project management support, including global supply chain management and kitting.

Purpose-built, AI-enabled technology capabilities designed to speed up and optimize every phase of clinical development.

Comprehensive mammalian cell line development (CLD) services designed to streamline biologics manufacturing from early-stage development to full-scale clinical and commercialization, utilizing AI- and ML-based gene optimization and high-throughput technologies.

End-to-end drug Chemistry, Manufacturing & Controls (CMC) strategies and regulatory support spanning the product lifecycle from development through clinical and commercial.

Proprietary computational modeling program that analyzes a compound's specific molecular structure and chemical characteristics to predict solubility and bioavailability enhancement.

A cutting-edge solution designed to provide unparalleled oversight into cold chain supply management, offering global visibility into shipments in real time.

A solvent-free, fusion-based process utilizing frictional and shear energy to rapidly process an API and polymer/excipient blend into an amorphous solid dispersion.

Supply, basic distribution, and logistics with limited and light project management (PM) support.

Proprietary softgel technology offered at the High Point, NC manufacturing facility.

Proprietary softgel technology used for chewable dosage forms with taste masking development.

Proprietary softgel technology offered at the High Point, NC manufacturing facility for gelatin based drug delivery.

Digital content distribution platform designed to enhance the clinical trial experience by making essential drug information more accessible to patients via a QR code.

End-to-end supply chain management service providing legal responsibility for imported goods compliance and tax payments.

End-to-end cold and ultra-cold supply chain solutions for correct material storage and temperature-controlled delivery.

Thermo Fisher Scientific's AI/ML powered digital toolbox and predictive modeling platform that helps biotech innovators solve formulation challenges, deliver data-driven foresight into solubility, permeability, bioavailability, FIH dosing, packaging, and scale-up planning.

Comprehensive transportation management service ensuring clinical trial products reach destinations efficiently and at the right temperature.

Streamlined service combining IOR and VAT reclaim requirements into one contract with consolidated invoicing.

Technology that incorporates enteric properties directly into the gelatin shell, removing extra coating steps during manufacturing for consistent enteric behavior.

Proprietary patient-centric soft lozenge technology designed to provide a soft and soothing sensory mouthfeel for comfortable delivery of active pharmaceutical ingredients (APIs) with superior taste-masking and a sugar-free option.

Softgel technology suitable for liquid formulations, faster onset of action, low-dose products, and poor bioavailability compounds benefiting from lipid systems.