Oral solid dose (OSD) development and manufacturing services
Confidently navigate every stage of your OSD product’s lifecycle
Oral solid dosage (OSD) forms are the most popular and preferred by patients due to their ease of administration, efficiency, cost-effectiveness, and shelf stability. Thermo Fisher Scientific offers state-of-the-art global capabilities, expertise, and a highly qualified team to support OSD development from discovery and early phases through late-phase clinical manufacturing, scale-up, registration, process validation, and commercial production.
Our skilled scientists and engineers work closely with clients to develop customized OSD formulations and processes, ensuring robust and high-quality products that meet the predetermined target product profile (TPP). With comprehensive services ranging from simple to complex OSDs and a strong regulatory track record, Thermo Fisher Scientific is the industry’s most trusted CDMO partner. Our end-to-end solutions help clients streamline vendor management and logistics, allowing them to focus on their core objectives and company vision.
60-70%
Sixty to 70% of molecules in clinical development have high permeability but poor solubility; predictive modeling can help
78%
We are involved with 78% of the top-performing drug products, delivering reliability and quality
>700
We worked on over 700 large and small molecules in 2022
3 of the top 8
We have developed and launched 3 of the top 8 best-selling small molecule drugs
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.
Read more: Inside drug development: The fundamental principles of pharmaceutical formulation
Thermo Fisher Scientific provides comprehensive end-to-end services, from early-phase formulation development to late-phase process optimization and commercial manufacturing.
Early-phase development services
Our early-phase formulation development scientists have the breadth and depth of experience and expertise to support your needs at every step.
- Accelerate your project to first-in-human (FIH) studies
- Rapid preformulation to characterize drug substance and excipient compatibility
- Rapid stability evaluation of prototype formulations using ASAP stability program
- Quickly evaluate formulation options using algorithmic-based tools and our expertise
- Enhanced solubility techniques to improve bioavailability
- Pave the way for preclinical and clinical studies
- Develop, validate, and implement analytical and process methodologies
- Generate the CMC data required for IND filings
In addition, as part of our end-to-end solutions, our clinical research group experts offer comprehensive clinical support to ensure a successful IND filing. For more information, please visit our Integrated CRO and CDMO Solutions | PPD Inc.
The solubility of oral solid dose drugs presents an increasing threat to molecule advancement through the drug development pipeline, particularly since a majority of current new drug candidates exhibit poor solubility. Without dissolution and absorption into the bloodstream via the gastrointestinal tract, drugs cannot achieve systemic circulation to exert their intended effects. Addressing solubility is thus crucial to overcoming bioavailability hurdles.
Thermo Fisher Scientific provides a comprehensive range of solubility enhancement solutions, including spray drying, hot melt extrusion (HME), lipid formulation, micronization, and solid state chemistry. Learn more on our Bioavailability and solubility enhancement page.
In silico modeling technologies are transforming drug development and manufacturing by enhancing efficiency and accuracy while fostering innovation. Powered by artificial intelligence, machine learning, bioinformatics, molecular dynamics simulations, and systems biology, these cutting-edge tools help accelerate the development of new drugs, optimize their formulations, ensure quality in manufacturing, and streamline regulatory processes, all while potentially reducing costs and time to market.
Advantages of Thermo Fisher Scientific’s engineered solutions:
- Mitigate development risks and minimize experimental failures
- Expedite development timelines
- Reduce overall costs
- Conserve valuable API resources
- Enable informed decision-making and rational drug design
- Diminish dependency on animal testing
To learn more about Thermo Fisher Scientific’s digital modeling services, visit our in silico modeling page.
Late-phase development and commercial services
Thermo Fisher Scientific specializes in late-phase development of OSD forms, ranging from simple immediate-release formulations to complex dosage forms such as osmotic drug delivery, modified release, high-potency compounds, DEA-controlled substances, spray drying, hot melt extrusion (HME), and bead coating. Backed by an industry-leading network, we have the global and regional resources to meet your specific needs. With over 40 years of experience in developing a wide range of OSD forms, Thermo Fisher Scientific has successfully supported the commercial launch of numerous projects for our clients. Our expert scientists excel in designing customizable solutions tailored to meet your commercial production needs.
Our facilities are equipped with commercial packaging lines capable of packing finished products in bottles, blisters, stick packs, and sachets. With integrated laboratories and extensive network lab testing capabilities, we can develop and validate analytical methods for experimental batch testing, stability studies, clinical trial material (CTM), and commercial batch release. Our late-phase services include CTM supplies for phase II and III trials, registration support, scale-up, process validation, site transfers, and commercial manufacturing. At Thermo Fisher Scientific, we are dedicated to meeting your project timelines while upholding the highest standards of quality, delivering right-first-time, on-time results.
Advantages of Thermo Fisher Scientific’s services:
- Strong regulatory track record
- Multiple commercial launches
- Expertise in scale-up and GMP manufacturing
- Global capacity expansion to meet growing commercial needs
- Global quality standards across all sites
- Qualified personnel
- Digital platforms for project and business management
- Logistics management
- Flexible capabilities to accommodate small-scale through large-scale projects
Process development, scale-up, and validation
Our scale-up solutions will give you access to a risk assessment and proven acceptable range (PAR) studies, as well as validation of analytical methods and manufacturing processes. If needed, our QA and regulatory compliance team can provide data and support for the Chemistry, Manufacturing, and Controls (CMC) portion of your submission. Active pharmaceutical ingredients (API) for use in clinical trials are produced at our state-of-the-art manufacturing facilities located in Europe and North America.
All our facilities adhere to current Good Manufacturing Practice (cGMP) regulations and undergo regular inspections by national and international regulatory agencies. A team of experts will support your discovery with a full range of technologies and analytical services to ensure flexibility and timely delivery with exceptional yields and superior quality. In late-stage trials and beyond, your drug substance will be manufactured at one of our cGMP-compliant commercial production facilities.
Oral solid dosage forms and related profiles
Having access to both conventional and specialized dosage forms, ranging from simple to complex, enables an integrated drug formulation program tailored to the unique properties of your molecule. Collaborating closely with you, we ensure that your discoveries have a proof-of-concept designed for speed and efficiency, accelerating your molecule's progression to first-in-human (FIH) studies.
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 Scientific pharma services grants you access to a broad selection of dosage forms and release profiles, including:
Immediate release:
- Dispersible tablets
- Oral disintegrating tablets
- Buccal tablets
- Sublingual tablets
- Chewable tablets
- Swallowable film-coated tablets
- Bilayer tablets
- Trilayer tablets
- Tablet in a tablet
- Mini tablets
- Pellets
Modified release/controlled release/sustained release:
- Enteric-coated tablets
- Gastro-retentive tablets
- Matrix tablets
- Pulsatile release tablets/pellets
- Multi-unit particulate system (MUPS) tablets
- Osmotic 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
Capsules are one of the most common oral dosage forms and include medication that’s enclosed in an outer shell. This outer shell is broken down in the digestive tract and the medication is absorbed into the bloodstream and then distributed and metabolized in much the same way as medication from a tablet.
Thermo Fisher Scientific produces many different types of capsules, most popular are listed below:
Capsules:
- Powder/granules in capsules
- Coated pellets in a capsule
- Enteric release capsules
- Gelatin/HPMC capsules
- Liquid-filled hard capsules
- Softgel capsules
- Mini tablets in capsules
- Tablet in a capsule (over encapsulation)
Individual dose packing:
- Stick packing
- Sachets
In addition to these technologies, we can also fill powder in a bottle.
Non-sterile oral liquids including solutions and suspensions can be developed and commercially manufactured at our network sites.
Oral solid dose (OSD) manufacturing
At Thermo Fisher Scientific, we understand the complexities and challenges involved with bringing pharmaceutical products to market. With our comprehensive commercial manufacturing services, we offer pharmaceutical and biotechnology companies a trusted partner to navigate the journey from development to commercialization seamlessly.
Visit our commercial manufacturing service page to learn more.
Thermo Fisher Scientific has a global network of sites 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, with 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
- Osmotic drug delivery
- Pelletization
- Sachets/stick packs
- Powder in a bottle
- Coating
- Printing
- Visual Inspection
Our end-to-end global clinical supply chain services, formerly known as Fisher Clinical Services, are powered by people with an unwavering dedication to serving clinical research and patients worldwide. With over 30 years of experience in clinical trial services, we offer support and expertise across your supply chain, whether your investigational medicinal product (IMP) is a traditional small molecule, biologic, or advanced therapy.
Visit our clinical trial services page to learn more.
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.
Visit our regulatory services and support page to learn more, or contact our regulatory specialists.
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.