Oral solid dose (OSD) manufacturing and development services
Confidently navigate every stage of your OSD product’s lifecycle
Oral solid dose (OSD) refers to pharmaceutical dosage forms including tablets, capsules, and pellets administered orally. OSD is the most widely used drug delivery format due to stability, manufacturing efficiency, and patient compliance. Thermo Fisher Scientific provides integrated OSD development and manufacturing services from early development through commercial production.
Our services span early-phase formulation development, late-phase scale-up, and commercial manufacturing for tablet and capsule dosage forms, including complex formulations. These capabilities are supported by state-of-the-art facilities, experienced scientific teams, and a strong regulatory track record.
Key oral solid dose highlights
135 NDAs approved
Thermo Fisher Scientific provided CDMO services for 135 NDAs that received FDA approval in the USA between 2011 and 2024.
400 molecules analyzed
Our Quadrant 2™ AI-powered platform analyzed 400 molecules for solubility improvements from 2014 to 2024, optimizing early development.
9/10 best-selling drugs
We provided development and manufacturing services and solutions for 9 of the top 10 best-selling small molecule blockbuster drugs in 2023.
Over 13 billion dose units
In 2024, our state-of-the-art facilities and equipment produced 13.5 billion oral dose units, including 7.6 billion tablets/capsules and 5.9 billion softgels.
Dosage forms and release profiles
Thermo Fisher provides oral solid dose development and manufacturing services for tablets and capsules across immediate-release, modified-release, and controlled-release profiles.
Tablet manufacturing and formats
Our formulation scientists leverage a diverse array of technologies and approaches to control the release of the active pharmaceutical ingredient (API) according to your requirements.
Partnering with Thermo Fisher pharma services grants you access to a broad selection of dosage forms and release profiles, including:
Immediate release:
- Oral disintegrating tablets
- Sublingual tablets
- Buccal tablets
- Chewable tablets
- Dispersible tablets
- Bilayer tablets
- Trilayer tablets
- Pellets
- Swallowable film-coated tablets
- Tablet in a tablet
- Mini tablets
Modified release, controlled release, and sustained release:
- Enteric-coated tablets
- Osmotic tablets
- Matrix tablets
- Pulsatile release tablets/pellets
- Gastro-retentive tablets
- Multi-unit particulate system (MUPS) tablets
- Bilayer tablets (IR/MR combination)
- Trilayer tablets (IR/MR combination)
- Modified release coated mini tablets
- Modified release pellets
- Hot melt produced cut rods and tablets
Capsule manufacturing and formats
Thermo Fisher manufactures a wide range of capsule formats to support clinical and commercial oral solid dose programs, including hard gelatin, HPMC, liquid-filled, and multiparticulate capsules.
Our most popular capsule formats are:
- Softgel capsules
- Powder/granules in capsules
- Coated pellets in a capsule
- Enteric release capsules
- Gelatin/HPMC capsules
- Liquid-filled hard capsules
- Mini tablets in capsules
- Tablet in a capsule (over encapsulation)
Individual dose packing options:
- Stick packing
- Sachets
- Powder in bottle
Oral solid dose formulation development services
Formulation development is a pivotal step in drug development, as it directly affects the safety, efficacy, pharmacokinetics, and patient compliance of a medication. This process involves creating a suitable formulation and manufacturing method to produce a finished product that meets the desired target product profile (TPP).
A well-designed formulation ensures that the active pharmaceutical ingredient (API) is effectively delivered within the body, maximizing therapeutic impact while minimizing adverse effects. Through formulation and process development, it’s possible to achieve the desired TPP, which is essential to establishing safety and stability data during clinical evaluation and developing a viable process for commercial manufacturing.
Early‑phase development services establish the foundation for successful clinical and commercial programs.
Our scientists have the breadth and depth of experience and expertise to support your needs including:
- Accelerating your project to first-in-human (FIH) studies
- Rapid pre-formulation to characterize drug substance and excipient compatibility
- Rapid stability evaluation of prototype formulations using ASAP stability program
- Quickly evaluating formulation options using algorithmic-based tools and our expertise
- Enhanced solubility techniques to improve bioavailability
- Paving the way for preclinical and clinical studies
- Developing, validating, and implementing analytical and process methodologies
- Generating the CMC data required for IND filings
In addition, as part of our end-to-end solutions, our clinical research group experts offer strategic clinical development support. For more information, please visit explore our integrated CRO and CDMO solutions.
The solubility of small molecules presents an increasing threat to molecule advancement through the drug development pipeline, particularly since most current new small molecules drug candidates exhibit poor solubility. Thermo Fisher addresses these challenges through integrated formulation development, solubility enhancement technologies, and predictive modeling services designed to improve bioavailability while maintaining scalability.
We provide a comprehensive range of solubility enhancement solutions, including spray drying, hot melt extrusion (HME), lipid formulation, micronization, and solid state chemistry.
In silico modeling technologies support formulation and process decisions by enabling predictive assessment of solubility, dissolution behavior, and formulation performance. These tools complement experimental development to reduce risk and guide formulation strategy.
Late‑phase oral solid dose services support the transition from clinical development to commercial manufacturing. With decades of experience supporting oral solid dose products, Thermo Fisher has supported the commercial launch of numerous programs across a range of dosage forms. Since 2011, we received the manufacturing contracts for 135 small molecule FDA approved products.
Our scientists design late-phase oral solid dose solutions that support scale-up, validation, and commercial readiness across a broad range of dosage forms. These solutions include:
- Facilities equipped with commercial packaging lines to support packing finished products in bottles, blisters, stick packs, and sachets
- Network of laboratories to develop and validate analytical methods for experimental batch testing, stability studies, clinical trial material (CTM), and commercial batch release
- Phase II and III clinical trial material supply
- Technology transfer planning and execution between development and commercial manufacturing facilities
- Process scale‑up and optimization
- Process validation and continued process verification
- Regulatory and registration support
Services are delivered through a global network of GMP‑compliant facilities with experience across a broad range of oral solid dose products.
There is a shift toward digital tools like AI and ML in OSD development, driven by the need for predictive insights when materials are limited, timelines are tight, and the data are incomplete. Traditional methods that rely on empirical, sequential experimentation through trial and error can waste precious API and valuable time.
There is a rising recognition that digital tools provide a level of predictive certainty that physical trials simply cannot match in terms of time and costs. At Thermo Fisher Scientific, our digital maturity is anchored by our immense scale as a global CDMO. The vast global scale in which our company operates avail us to immense amounts of proprietary data that make our AI models precise. Using AI in early drug development help narrow experimental paths and reduce unproductive trails to preserve scarce API, accelerate learning, and generate data that support confident discussions with regulators and investors. Importantly, this early development phase forms the foundation of how customers demonstrate asset visibility through clear scientific rationale, more reliable timelines, and more efficient use of limited materials.
With our comprehensive commercial manufacturing services, we offer pharmaceutical and biotechnology companies a trusted partner to navigate the journey from development to commercialization seamlessly.
Our global network of sites is strategically located to meet the diverse needs of our clients, both locally and globally. To ensure successful scale-up and commercial launch, all our development equipment is aligned with commercial capabilities.
We offer a broad spectrum of commercial capabilities tailored to our clients' needs, including the following technologies available for manufacturing OSD forms:
- Direct blending
- Wet/dry granulation
- Fluid bed coating — both top and bottom spray
- Hot melt extrusion (amorphous solid dispersions, pellets, cut rods, melt granulation)
- Spray drying
- Encapsulation
- Tableting and pelletization
- Coating
- Printing
- Visual inspection
- Additional digital technologies
Related services to support your molecule:
- Small molecule API drug development services: Our API development services offer comprehensive expertise and support—from early process optimization and route scouting through scale-up and commercial manufacturing—to accelerate your API’s journey from concept to market.
- Clinical trial services: Our end-to-end global clinical supply chain services are powered by people with an unwavering dedication to serving clinical research and patients worldwide.
Our strong and diverse regulatory expertise, based on solid knowledge of the requirements of major entities (ICH/EMA/FDA) and a commitment to staying abreast of new regulatory trends, is the foundation that enables us to deliver exceptional services continuously recognized by our customers.
To serve our client needs we have development centers and commercial manufacturing sites located in North America and Europe. All our sites are approved by the major and country specific regulatory agencies, and they are equipped to produce drug products for both regional and international markets. We offer QP release to certify a batch meets GMP and requirements of a CTA (Clinical Trial Application) or Marketing Authorization Application (MAA).
Visit our regulatory services and support page to learn more, or contact our regulatory specialists.
Explore our state-of-art OSD global network of sites
Thermo Fisher Scientific offers a global network of facilities dedicated to the development and manufacturing of OSD products.
Our Whitby Site specializes in commercial manufacturing for a full range of conventional dosage forms with specialized capabilities, and houses a fully integrated pharmaceutical development services (PDS) facility.
Our Manatí facility specializes in the medium to high volume commercial manufacture of solid dosage forms including tablets, capsules, bulk granules, and powders packaged in bottles.
With over 750 employees, our Thermo Fisher Scientific site in Cincinnati offers controlled and sustained release solid oral dosage forms, osmotic release dosage forms (laser drilling), liquid fill hard capsules, controlled substances manufacturing, abuse deterrent dosage forms.
Our Bend facility is our site network’s Center of Excellence for Solubility. The Bend site campus is divided into two main buildings; one devoted to business services and manufacturing, the other to warehousing, receiving, shipping, R&D and QC Laboratory services. The manufacturing facility comprises two separate areas including formulation and process development as well as cGMP manufacturing.
Our Toronto facility covers all phases of drug product development from early-phase formulation development to clinical trial material to commercial supply in the same plant using scalable equipment for non-GMP and GMP Work. Our experts at the Toronto facility are ready to address your needs for highly potent, low potent, complex formulations, pediatric dosage forms, patent-extension strategies, as well as conventional oral solid formulations.
Our facility in Bourgoin, France is an FDA-approved center of excellence for early- and late-stage development and commercial manufacturing for oral solid dose (OSD) products, with a specialization in handling highly potent APIs.
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