Pharmaceutical Development Services

Product Description

Patheon enables its customers to bring drug candidates from preclinical stages through to clinical trials, the NDA approval process and, if approved, commercial manufacturing. Patheon offers the full breadth of advanced scientific and preformulation services through to late development in solid and sterile dosage forms, as well as specialized capabilities in high potency, controlled/sustained release, and sterile manufacturing, including aseptic filling and lyophilization. Very few CDMOs can bring this big-picture perspective to building success into both solid and sterile pharmaceutical products. We give you access to a remarkably wide selection of formulation technologies.
• Conventional and specialized oral solid dose formats, including softgels and softgel technologies
• Liquid and lyophilized sterile products, including prefilled syringes and cartridges
• High potency products and controlled substances
• Solubility and bioavailability enhancement expertise

Thermo Fisher Scientific Inc.

  • US
  • 2015
    On CPhI since
  • 5000+
Contract Service
  • Supplied from
    United States
  • Measured In

Thermo Fisher Scientific Inc.

  • US
  • 2015
    On CPhI since
  • 5000+
Contract Service

More Products from Thermo Fisher Scientific Inc.

  • Active Pharmaceutical Ingredients

    Product Active Pharmaceutical Ingredients

    We cover the spectrum from clinical to commercial services to outsource active pharmaceutical ingredients (APIs), registered intermediates (RIs), and registered starting materials (RSMs). DSM services encompass most commercially-used chemical conversions. Some of our specialities include:

    •Chiral technologies
    •Homogenous catalysis
  • Commercial Manufacturing Capabilities

    Product Commercial Manufacturing Capabilities

    As the global leader in large-scale pharmaceutical manufacturing, Patheon offers extensive commercial capabilities and capacity for drug product manufacturing. We have a global network of twelve fully integrated world-class commercial scale facilities – all preapproved by international regulatory agencies, and all maintaining the highest standards of quality and service. We take pride in our steadfast reliability, unmatched regulatory track record but also in our spirit of innovation, as demonstrated by our introduction of the world’s first sterile backup supply service. Over the course of nearly 40 years Patheon has earned the trust of the most quality-conscious pharmaceutical companies by being able to provide exceptional service in:
    • Large-scale capabilities and capacity at facilities around the world
    • Wide variety of solid, sterile and softgel dose forms
    • Award-winning technology transfers and scale-up
    • Expertise in complex formulations, controlled substances and highly potent compounds
    • Primary and secondary packaging
  • Formulation Development

    Product Formulation Development

    Patheon offers pharmaceutical development services,
    analytical development services, and clinical trial
    material manufacturing for solid dosage forms.
    • Preformulation Services
    • Formulation Services
    • Analytical Research Support
    • Laboratory Facilities
    • Clinical Trial Material
    Manufacturing—Solid Dose
  • Biologics

    Product Biologics

    From pre-clinical development to commercial supply, Patheon is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully integrated network of facilities. These world-class cGMP sites feature USP and DSP processes and technologies that enable us to meet your preclinical, clinical and commercial milestones and goals for even your most challenging projects. With unmatched flexibility, Patheon gives you access to a breadth of options and technical expertise in biologic drug substance that will transform your expectations for yields, time to market and costs and that is supported by sterile manufacturing, including aseptic filling and lyophilization.
    • Process and analytical development of mammalian cell culture drug substances
    • Clinical and commercial cGMP manufacturing via fed-batch, perfusion and XD®
    • cGMP and non-cGMP supply
  • Blister Packs

    Product Blister Packs

    Blister Packaging • Thermoform • Cold Form • Push-Through or Child Resistant • Online Foil Printing • Pre-printed foil • Color Vision Systems • Inserts & Coupons • Hospital Unit Dose • Compliance promoting Other Packaging • Pouches and Packets
  • Capsules/encapsulation

    Product Capsules/encapsulation

    Blending Granulation and Compression
    • Direct compression blending
    • Wet granulation
    • Dry granulation
    • Top spray granulation
    • High and low shear granulation
    • Tray
    • Microwave
    • Wurster drug layering and coating
    • Aqueous and solvent film coating
    • Sugar coating
    • Sustained-release bead coating
  • Cell Culture

    Product Cell Culture

    We offer world-class technologies and manufacturing services to the biopharmaceutical market, incorporating mammalian cell lines as production platforms for recombinant proteins and monoclonal antibodies on all commercial cell lines, including CHO, Hybridoma and PER.C6® cell line.
    •Range of mammalian bioreactor sizes from 50L – 1,000L, combined with strong process and analytical development capabilities.
    •Stainless steel and Single Use Bioreactors
  • Contract Manufacturing of Dosage form Drugs

    Product Contract Manufacturing of Dosage form Drugs

    Our finished product services include aseptic filling, lyophilisation, cytotoxic and clinical trial manufacturing, tablets/capsules, scheduled drugs and a variety of packaging services. •Aseptic liquid filling – with LiquidAdvantage proprietary distribution control system •Lyophilisation – with LyoAdvantage software for cycle control •Clinical trial manufacturing – post discovery, cGMP Phase I, II, III or ready for commercial manufacturing •Solid dosage form •Packaging
  • Custom Manufacturing

    Product Custom Manufacturing

    Patheon is a leading provider of contract development and commercial manufacturing (CDMO) services to the global pharmaceutical industry for a full array of solid and sterile dosage forms. Patheon, a DPx Holdings B.V. business unit, encompasses the combined CMO capabilities and pharmaceutical product development services (PDS), as well as the Biosolutions and Biologics (BIO) business.
  • Drug Delivery Systems

    Product Drug Delivery Systems

    • Biomedical materials science for advanced
    drug delivery technologies
    • Proprietary bioresorbable polymers for
    implantable drug delivery systems
    • Precise target area controlled release
  • Outsourcing

    Product Outsourcing

    Patheon has a broad biomanufacturing platform for pharma and bio-industrial products which provides sustainable solutions for mammalian cell-based and microbial-based manufacturing, green chemistry R&D and manufacturing technologies, and finished dosage production of biopharmaceuticals. With an offering covering early stage development through clinical trials to the full commercial production and packaging, DSM serves the breadth of the biopharma value chain.
  • Softgels

    Product Softgels

    Softgel Capsules
    EnterlCare® Enteric Softgels
    Twist-Off Softgels
    LiquilSoft™ Chewable Liquid-Filled Softgels
    Versatrol™ Controlled-Release Softgels
    Solvatrol™ Enhanced Solubility Softgels
    Soflet® Gelcaps
    Chewels® Chewable Gels
    EcoCaps™ Non-Animal Softgels

Thermo Fisher Scientific Inc. resources

  • News Viral vector demand to flourish on wave of imminent approvals, CPhI Worldwide audience told

    Expected increase in approvals for gene therapies, gene-modified cell therapies and recombinant vector vaccines will also increase pressure on manufacturers to build new capacity
  • Brochure Five ways to get to IND_IMPD faster

    The road to IND/IMPD isn’t always easy. Balancing speed, risk, and future needs is a challenge. So how do you get to IND/IMPD faster without sacrificing quality and future commercialization goals? Our experts have shared a few things to consider when thinking about accelerating and optimizing your early development process.
  • News Increasing demand for outsourced manufacturing due to changing Chinese market conditions, CPhI Worldwide conference told

    Rise of innovative companies with high-risk portfolios will necessitate need for CDMOs, says Thermo Fisher senior executive

  • Brochure Made with proof & purpose

    Your molecule has the potentialto change lives and shape thefuture. That’s why you need apartner you can trust.
  • News CPhI Webinar: mRNA vaccines, Trends, Technologies and Supply Chain

    The COVID-19 pandemic has meant scientists, together with pharmaceutical companies, have had to reinvent how to bring vaccines to market faster without impacting product quality, safety, or efficacy, according to experts speaking at a recent CPhI webinar.
  • Brochure Patheon pharma services_ Get the facts

    Industry-leading, end-to-end pharma services capabilities to simplify your supply chain
  • News Thermo Fisher takes on operational responsibility for new Swiss biologics manufacturing site

    The 1.5 million-sq. ft Switzerland-based facility is part of the company's strategic partnership with CSL Limited
  • Brochure Pharma Services' scientific innovation and investments

    Simplifying and accelerating your journey to market by providing the end-to-end solution you need.
  • Sponsored Content Thermo Fisher Scientific Opens cGMP Plasmid DNA Manufacturing Facility in Carlsbad, California

    Responding to critical market capacity constraints, Thermo Fisher announces the official opening of new 67,000 sqft cGMP plasmid DNA manufacturing facility in Carlsbad, CA. This site expands clinical and commercial capabilities for cGMP plasmid DNA used as a critical raw material to develop and manufacture cell and gene-based therapies in addition to capabilities to produce large-scale plasmid DNA as a primary drug substance for DNA therapies.
  • Brochure Drug repurposing trends and strategic approaches for shortening timelines

    As the complexity of drug development increases, so does the industry’s focus on strategies and solutions that can help bring advanced products to market as quickly as possible. Lowering the cost of R&D is also a key factor, as new chemical entities and de novo drugs in clinical phases face high attrition rates, with companies losing significant investments in nonviable candidates. One approach to avoiding this fate is drug repurposing, where known clinical candidates or commercially approved molecules are evaluated for new targets and indications. Understanding drug repurposing, how it can significantly reduce your time to market, and the important role established and knowledgeable CDMOs can play in this journey is critical to finding success with this emerging strategy.
  • News Thermo Fisher Scientific Opens Biologics Manufacturing Site in Lengnau, Switzerland

    Thermo Fisher Scientific Inc., the world leader in serving science,  announced that it has assumed operational responsibility for a new biologics manufacturing site in Lengnau, Switzerland as part of its strategic partnership with CSL Limited announced last year. The Lengnau site will become part of Thermo Fisher's global biologics manufacturing network, and approximately 200 employees will join Thermo Fis
  • Brochure Setting a strong foundation for your oral solid dose product to support late-stage development

    Drug sponsors face significant pressure to reduce the time required to move a new molecule through Phase I and into Phase II trials. If all goes well, identifying the quickest scale-up path for supplying efficacy trials and commercial demands is next. But at early stage, sponsors need to keep the formulation as simple as possible. This means identifying the desired critical quality attributes of a formulation and selecting only those must-have requirements that align closest to the objectives of each clinical trial stage.
  • News Thermo Fisher to build facility in Nashville for production of single-use technologies products

    Investment will further expand CDMO's global network of SUT facilities to boost reliable supply of critical materials used to produce new biologics and vaccines
  • Brochure Navigating the Adoption of Continuous Pharma Manufacturing Amid Unprecedented Global Challenges

    In addition to the devastating impact the COVID-19 global pandemic has had on public health, the economy, and the overall quality of our day-to-day lives, it has also exposed significant risks in today’s pharmaceutical supply chain. Improvements in speed to market and quality assurance, among other factors, need to be made to ensure not only the timely delivery of safe and efficacious drugs but also the stability necessary to manage future risks and disruptions.
  • News Thermo Fisher Scientific and AstraZeneca sign NGS-based CDx co-development agreement

    Companies say earlier collaboration may speed development and introduction of targeted precision medicine therapies for patients.
  • Brochure Impact of a Pandemic Outbreak on Vaccine Development Approach

    Over the past decade, outbreaks of H1N1 influenza, Sars-Cov, Ebola, and MERS have triggered several discussions about traditional vaccine development methods1. For example, new platform technologies, such as the use of messenger RNA (mRNA) vehiculated through lipid nanoparticles, have been introduced, stimulating scientific discussions. With the spread of SARS-CoV-2 intensifying, scientists, together with pharmaceutical companies, are reinventing the approach of how to bring these life-saving drugs to market faster without impacting product quality, safety, or efficacy.
  • News Thermo Fisher pledges to reach carbon neutrality by 2050

    Accelerated efforts align with the Paris Agreement and Race To Zero to combat climate change
  • Whitepaper Getting to first-in-human clinical trials_ A make-or-break milestone for small biopharmas

    “Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market quicker than ever before. The incentive of securing market share with first-to-market offerings is felt by all industry players. Pressure mounts from here for small companies, which often must meet certain milestones before receiving funding from investors. Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for cash-strapped companies whose hopes for success hinge upon just one or two molecules.
  • News Thermo Fisher supports gene developers with new AAV manufacturing solutions

    A new media panel, gene kit and advanced resins help reduce manufacturing costs and increase the viability of gene therapies
  • Whitepaper Strategic CDMO partnerships: Leveraging infrastructure investments and innovation to accelerate biologics development

    Rising to the challenges of biologics development in this period of disruptive change requires an appreciation for the science, technology, and market forces driving the transformation and a willingness to adopt strategies that align with these changes. For most pharmaceutical and biotech companies, this means identifying trusted partners who can provide access to innovative technologies and methodologies, sufficient manufacturing capacity for growing biologics demand, deep expertise in navigating regulatory channels, and the operational efficiencies needed to accelerate speed to market. This report provides a roadmap for assessing and selecting the right partner to get promising biological therapies to patients quickly.
  • News Thermo Fisher buys Novasep viral vector manufacturing business

    Expanded global capacity addresses growing demand for cell and gene therapy
  • Video China: Opportunities & High Growth Potential for Global and Domestic Pharma

    Originally broadcast as part of the CPhI Worldwide 2021 digital content agenda, this session will provide an overview of the opportunities and challenges for growth in the world's second largest pharma market. Speakers from Thermo FIsher and Informa Pharma Intelligence will explore some of the consistent drivers for investment and innovation trends through the views of thought leaders in China's pharma industry. Discussion points include: Market Dynamics & Industry Trends Opportunities in Drug Development and Clinical Research Best practices in supporting global Pharma companies to access China How Pharma companies in China can leverage the experience of the Global Market
  • News Thermo Fisher boosts clinical supply chain and distribution services in Europe

    Two new facilities in Germany will provide clinical supply and cold chain services to support growing demand
  • Video Building Viral Vector Capacity and Capabilities to Realise the Promise of Gene Therapies

    This session was originally broadcast live on 1 November as part of the CPhI Worldwide digital content programme, and is now available to view on-demand. Continuing advances in cell and gene therapy are transforming how biopharma companies treat and potentially cure certain diseases. This session will touch upon some of the opportunities, challenges, and implications for stakeholders in this fast-evolving field and provide a guide on how to Build Viral Vector Capacity and Capabilities to Realise the Promise of Gene Therapies. Discussion points include: Challenges and opportunities of bringing viral vector products to market Importance of building capacity and capabilities to meet future needs Addressing scalability challenges
  • News Thermo Fisher releases new CE-marked combo testing kit

    The single PCR-based diagnostic kit can detect and differentiate between SARS-CoV-2, influenza (flu) A/B, and RSV
  • Video Developments and Opportunities in Continuous Manufacturing

    This session was originally broadcast as part of the CPhI Worldwide digital content programme. Continuous Manufacturing is a premier event for modernizing pharmaceutical manufacturing and accelerating commercial success. Even though the move towards the use of these techniques has been slow, more and more facilities are choosing continuous manufacturing processes when introducing a new product. This session will explore: Level of adoption of continuous pharmaceutical manufacturing: Drivers and challenges The current state of continuous manufacturing of API, FDF, and biologics: Overview and key differences Importance of the catalytic role of National Regulatory Agencies and pharmacopoeias for increased continuous processing of the pharmaceutical products
  • News Thermo Fisher Scientific Opens New Bioprocessing Collaboration Center in St. Louis

    Thermo Fisher Scientific Inc., the world leader in serving science, announced the opening of its new Bioprocessing Collaboration Center (BCC) in St. Louis, Missouri.
  • Video mRNA vaccines, Trends, Technologies and Supply Chain

    Over the past decade, outbreaks of H1N1 influenza, Sars-Cov, Ebola, and MERS have sparked ongoing conversations about strategic approaches and responses to pandemics and epidemics. With the spread of SARS-CoV-2 intensifying, scientists, together with pharmaceutical companies, are reinventing how to bring these life-saving drugs to market faster without impacting product quality, safety, or efficacy. The response has its own set of complex challenges that traditional manufacturing methods won’t solve. This webinar will tackle some of the key lessons learned from the COVID 19 situation, the role, application, and potential of mRNA Vaccines technologies, as well as some of the challenges and considerations for achieving a robust global vaccine supply chain.
  • News INOVIO signs up Thermo Fisher to support COVID-19 vaccine production

    The CDMO will support INOVIO's plans to have 100 million doses of COVID-19 vaccine candidate INO-4800 manufactured in 2021.
  • Video The Lasting Impact of COVID-19 on Drug Development

    A disrupter event to many businesses and industries worldwide, what lasting impacts will be felt and what can pharma learn from the COVID-19 pandemic in terms of the acceleration of drug development and repurposing in the future; the broader impact on how trials are conducted, and the impact of virtual clinical trials for clinical supplies business. Discussion Points Fast-tracking R&D Emergency use approvals Drug Repurposing Diversifying Clinical trials This session was originally broadcast live as part of CPhI North America 2021
  • News Thermo Fisher seals US government deal to supply VTM tubes for COVID-19 testing

    CDMO aims to ramp up production to 8 million tubes per week via $40 million Lenexa site expansion
  • Video Navigating Decision Points to Fast-Track Commercialisation

    This webinar originally aired as part of CPhI Discover - 17-28 May 2021 Understanding the risks, requirements and challenges of bringing clinical products through validation and to the market are vital for the success of your large molecule project. Whether you are experiencing resource constraints or struggling with the right level of technical expertise, navigating key decision points within early development can pose a lot of challenges. Optimizing your decision making can save time and costs by avoiding rework and delays. During this webinar, learn more about: Strategies for formulation development vs. process development How to change presentation/dose and the appropriate timing Selecting the right scale at each phase and for commercial launch Limiting waste throughout your project Readiness for validation Executing PPQ Case studies: Small molecule lyo – large scale Large molecule liquid – small scale
  • News Thermo Fisher to more than double viral vector capacity through Plainsville addition

    CDMO will build a $180 million development and manufacturing facility to support increasing demand for cell and gene therapies and vaccines
  • Video Manufacturing Innovation: The Case for Continuous Manufacturing

    This webinar originally aired as part of CPhI Discover - 17-28 May 2021 Technologies with the potential to accelerate product development, reduce manufacturing costs and facilitate speed to market will be one of the leading change drivers for pharma manufacturing processes in coming years. Continuous Manufacturing has been widely touted as an approach for creating efficiencies in pharma manufacturing and accelerating commercial success. While industry adoption has been slow, more and more facilities are choosing continuous manufacturing processes when introducing a new product. What are some of the latest breakthrough technologies being implemented by pharmaceutical manufacturers? Guidance for Industry: Quality and regulatory Considerations for Continuous Manufacturing Batch vs Continuous Manufacturing Critical success factors and common pitfalls Hybrid-type manufacturing systems? Continuous manufacturing – a technology suited to new products and new facilities rather than existing ones?
  • News Thermo Fisher to invest more than $475 million this year on capacity and capability expansion

    Thermo Fisher Scientific will invest more than USD475 million in 2020 in new capabilities and capacity to meet increasing demand for biologics, cell and gene therapies and drug products, the contract development and manufacturing organisation said Monday.
  • Video Thermo Fisher Pharma Services: COVID-19 Mobilization

    We're working arm-in-arm with industry innovators, government agencies and academic institutions to provide scale, flexibility and expertise in the battle against COVID-19.
  • News Thermo Fisher Scientific to acquire Qiagen

    Thermo Fisher Scientific said Tuesday it has agreed to buy Dutch molecular testing and diagnostics specialist Qiagen for €39 per share in cash, valuing the overall transaction at around USD 11.5 billion.
  • News New advanced LC system delivers productivity, precision and compliance

    The Vanquish Core HPLC System maximizes the delivery of precise results with simple, seamless method transfer.

Recommended products