27 Jun 2024

Large molecule development and manufacturing

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Thermo Fisher Pharma Services is a full-service CDMO that has the expertise and comprehensive capabilities to seamlessly manage every step of your drug development and manufacturing journey—streamlining your process so you can get to market quickly. As a collaborative partner, we have a shared goal of helping you succeed. We have the skills and experience to help you mitigate risk and respond with flexibility, from drug substance to drug product to clinical trials, and all the way to commercial manufacturing.

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Thermo Fisher Scientific Inc.

  • US
  • 2015
    On CPHI since
  • 2
  • 5000+
Company types
Contract Research Organisation (CRO)
Primary activities
Clinical Research
Contract Manufacturer
Contract Research Organisation
Packaging & drug delivery
Supply Chain

Other Content from Thermo Fisher Scientific Inc. (82)

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    A contract research organization (CRO) supports biopharma companies by providing a wide range of early-stage drug research and development offerings, whereas a contract development and manufacturing organization (CDMO) supports sponsors by providing later-stage drug development and manufacturing services. In the pharmaceutical industry, it’s not uncommon for sponsors to independently collaborate with both a CRO and a CDMO partner at various stages of drug development, which can create unnecessary complexities and unanticipated challenges.

    Our new infographic explains the benefits of working with an end-to-end, integrated CRO/CDMO partner that provides a wide range of innovative research, development, and manufacturing capabilities. It also illustrates how a single, centralized vendor can offer improved simplicity, speed, and scalability on the journey from molecule to medicine to market.

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  • Whitepaper Optimizing the cell and gene therapy patient journey through integrated CRO/CDMO partnership

    Cell and gene therapies have the potential to fundamentally change treatment paradigms for patients living with a wide range of diseases, including genetic disorders, rare cancers, and neurological conditions.

    However, to prove their safety and efficacy, cell and gene therapies must make it through a series of clinical trials. Currently, the clinical trial process can be overly complex, which may negatively impact the patient experience of participating.

    Some of these challenges can be addressed through innovative research, development, and manufacturing strategies, as well as through patient-centric protocols, which fall under the purview of integrated CRO and CDMO partners.

    Our new whitepaper takes a deep dive into these topics, specifically covering:

    The overall importance of patient journey mapping to clinical trial successThe role of manufacturing in delivering cell and gene therapies ...
  • News The Patient-Centric Synergy of Pharmaceutical CDMO and CRO Collaborations

    Pharmaceutical collaborations are nothing new to the industry. Increasingly complex drug development programs, calls for supply chain resiliency, and the involvement of all key stakeholders throughout a drug’s development lifecycle are pushing contract development and manufacturing organisations to partner with their counterparts in research.
  • Whitepaper Trend Report: The Nexus Between Patient and Big Pharma

    Collaborations between contract development and manufacturing organisations (CDMOs) and contract research organisations (CRO) are on the rise. With complex therapeutics in the pipeline and the need for supply chain resiliency, these collaborations can offer more capabilities and services. With such collaborations proving to be more than just a current trend, what will the effect be on patients? In our latest report, in partnership with Thermo Fisher Scientific, we explore how CDMO and CRO collaborations with a strategic focus and the right intentions can only drive the industry towards a patient-centric future.
  • News Thermo Fisher Scientific expands its cell therapy development and manufacturing capabilities with new facility in San Francisco, CA.

     Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, and the University of California, San Francisco (UCSF), will accelerate advanced cell therapies for difficult to treat conditions, including cancer, rare diseases, and other illnesses, from a newly opened cGMP manufacturing facility adjacent to UCSF Medical Center’s Mission Bay campus.
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  • News Thermo Fisher Scientific expands with state-of-the-art facility in China

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  • Brochure Fact sheet: Biologics Quick to Clinic™

    The pressure to file an IND makes accelerated Phase I safety testing a priority. With the Quick to Clinic™️ program, Thermo Fisher Scientific can help deliver your large molecule drug substance for First-in-Human studies in as little as 13 months from the start of transfection. Platform available for mAbs, bispecifics, and FC fusion molecules. 

    Now you can meet important milestones—such as filing for IND—or secure additional funding with all the confidence your project needs and, we can supply.

  • 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.
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    Quick to Clinic™ is an integrated early development offering designed for biotech companies looking for a dependable solution to scale up recombinant antibodies from discovery to first-in-human (FIH) trials.
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  • Technical Data Maintaining the cold chain in European distribution

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    Your molecule has the potentialto change lives and shape thefuture. That’s why you need apartner you can trust.
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    A new media panel, gene kit and advanced resins help reduce manufacturing costs and increase the viability of gene therapies
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    Expanded global capacity addresses growing demand for cell and gene therapy
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    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 boosts clinical supply chain and distribution services in Europe

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  • News Thermo Fisher Scientific Opens New Bioprocessing Collaboration Center in St. Louis

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    The unique attributes of mRNA vaccine development The planning paradigm shift to address major process challenges and streamline workflow Global supply chain implications and the investments and innovations needed to manage them.
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    “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.
  • 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.
  • Whitepaper Protecting tomorrow_Supporting pharmaceutical and biotech industries to build a sustainable future

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    The impact of the new regulation on existing clinical trialsThe implications for good manufacturing practice (GMP) guidance and the Clinical Trial Application (CTA) processNew labelling requirements, the challenges they may pose, and potential solutionsThe UK’s approach to clinical trial regulation and the impact of the EU CTR changes on Qualified Person (QP) requirements and other legislation
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    In Dec 2021, Thermo Fisher completed the acquisition of PPD, Inc, a leading global provider of clinical research services to the biopharma and biotech industry. With the addition of PPD, Thermo Fisher will offer a comprehensive suite of world-class services across the clinical development spectrum – from scientific discovery, to accessing safety, efficacy, and health care outcomes, to managing clinical trial logistics, to the development and manufacturing of drug product.

    Today a panel of executives from Thermo Fisher will discuss how the addition of PPD’s leading clinical research services differentiates Thermo Fisher and advances our work in bringing life-changing therapies to market, benefiting patients around the world.

    Today’s learning lounge will provide insight into how a patient centric mindset influences: drug development and manufacturing decisions clinical trial recruitment, retention and trial management end-to-end processes, from early drug development to the patient

    Click here to register

  • Video Technology Transfers: Best practices for Optimizing Success and Mitigating Risk

    When working with the right partner and network, transferring production between sites allows companies to reap a variety of strategic advantages. Timeline and cost efficiencies can be gained when a trusted CDMO can take a product from development to commercial launch.

    They can safeguard supply by producing at more than one site, and improve distribution by moving production closer to a critical market. Program costs and risk can be reduced by moving production to sites that are better qualified or better positioned to meet the needs of regulators. But this is not without challenges.

    Learn how Thermo Fisher Scientific: Uses a network of technical experts and digital innovations for project management to overcome key industry challenges related to tech transfers Customizes the approach for the process transfer, stylizing it specific to our customers Takes the lead in effectively managing projects through the most complex regulatory strategies by executing consistent, quality manufacturing Applies an optimized governance model and an integrated network approach to de-risk and simplify the transition of the program to commercial stage In this learning lounge, we will showcase what differentiates Thermo Fisher Scientific in the technology transfer market and how the power of our network consistently delivers speed through efficiency.

    Click here to register

  • Video The Lasting Impact of COVID-19 on Drug Development

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  • Video Thermo Fisher Pharma Services: COVID-19 Mobilization

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  • Webinar Form and fit: Mobilizing integrated resources to transform complex small molecules into high-performing drugs

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  • Webinar Novel Excipient Pilot Program Review

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    Take months off the development timelines of your large and small molecule discoveries. With Thermo Fisher Scientific's Quick to Care™ program, you can combine your drug substance and drug product development, demand planning and clinical trial supply execution into a single customized solution to simplify your supply chain and accelerate your discovery through clinical development. This session was broadcast as part of the CPHI North America show.
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    The percentage of parenteral drugs approved continues to increase as the overall drug market expands and new therapies for chronic and rare diseases enter the pipeline. In addition to this, swift advancement in biosimilars and biological products is projected to drive the parenteral drugs market growth in the years ahead. Manufacturers face increasing complexity, not just because of the drug substances but also due to formulations, patient-centric delivery technologies, and regulatory requirements, which are all further complicated by abbreviated development timelines. This session will aim to look at trends and challenges in today’s parenteral manufacturing and development market. Discussion will cover: Discuss key trends in the parenteral dosage development and manufacturing market Overcome complex formulation challenges: solubility, stability, process Navigate a complex regulatory environment (IND, filing, etc.) Build success in early development to enable commercial success Shorten timelines to get to market quicker Bolstering Capabilities for Parenteral Drug Development & Build a robust process development program Why attend? Parenteral Drugs: Recent Approvals and Growth Dynamics Key Trends and Issues Impacting Parenteral Development and Manufacturing Overcoming challenges getting drugs to market. WATCH FOR FREE
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    A global leader with over 40 years of biologics manufacturing experience. Decades of partnerships with highly regarded pharmaceutical and biotechnology companies around the world, paired with scalable cGMP-compliant facilities and industry-leading technology, mean we have the knowledge and tools to provide solutions to our customers to move forward in this space. In this keynote, I will talk about the CDMO´s journey over decades, how the pivot came with COVID-19 and the technological advancements like Cell and gene therapies. It´s about addressing the industry challenge and being extended partner rather than mere service provider. Journey of the Global biotech Cooperations, Novartis CDMO to bring therapies to the patients
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    The pharmaceutical landscape is undergoing a dynamic transformation, driven by technological advancements and a renewed perspective on collaborations. Central to this transformation is the role of CDMOs as strategic partners. In addition to providing access to the cutting-edge technologies that are reshaping drug production and supply chain management, CDMOs offer critical insights and guidance to ensure these technologies are leveraged to their maximum potential, delivering unparalleled value. This is especially critical in today’s evolving pharmaceutical ecosystem, where bringing next-generation therapies to market requires adapting and configuring solutions and processes to specific molecule and technology needs. As strategic partners in these endeavors, CDMOs must not only be willing to embrace new business models, but also have the dedicated infrastructures to support them. Beyond the tangible advancements in materials, engineering, and manufacturing processes that serve as the foundation for progress, the intangible elements of partnership—trust, collaboration, communication, agility, and foresight, among others—truly catalyze success. These qualities empower teams to navigate the unique demands of each development project, ensuring that innovation finds its way from concept to reality. Join us as we explore how CDMOs are embracing innovation and redefining the partnership paradigm. The discussion will revolve around three pivotal developments shaping the industry's future: Fully flexible manufacturing solutions. Explore how CDMOs are leveraging adaptable platforms to cater to diverse production needs Continuous manufacturing. Understand how transitioning from batch-based to continuous processes enables enhanced product consistency, scalability, and efficiency. Digital enablement and analytical capabilities. Discover how digital enablement is unlocking new frontiers in product quality, regulatory compliance, and operational efficiency
    The value of a CDMO partner that delivers services from discovery to commercialization, maintaining scientific integrity and process efficiency
    The role of CDMOs in managing both scalability and quality, ensuring seamless transitions from early-stage trials to late-phase development.
  • Webinar CDMO Selection for the Biotech: A Practical Guide

    Join us as we dive into the key considerations of choosing a CDMO as a biotech, and how to select the perfect partner: Establishing a pre-partner checklist of what you need (regulation, manufacturing technology, and logistics) to avoid unnecessary costly measures Why understanding your molecule format will help drive the process pathway for your potential partner Creating clear communication lines and expectations from the start
  • Webinar CDMO Organization within Pharma, a Different Perspective

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    Outlining collaborative and communication strategies that can help enhance an outsourcing partnership The importance of information sharing between client and vendor for effective situation response Case study showcase of a successfully implemented partnership strategy
  • Technical Data cGMP plasmid DNA manufacturing services

    De-risk your path to commercialization with flexible plasmid solutions backed by proven quality systems 
  • Technical Data cGMP cell therapy manufacturing services

    Combining technical expertise with agile execution to address your unique cell therapy project needs 
  • Whitepaper Leveraging innovations in plasmid manufacturing to bring advanced therapies to market

    This whitepaper provides insight into the market trends influencing the manufacture and supply of pDNA for advanced therapies and offers an in-depth discussion of the key challenges associated with transitioning from GMP-like to full cGMP quality. Guidance is also offered to address these challenges, including recommendations related to critical quality attributes, upstream processing, formulation and fill/finish, analytics, and flexible capacity planning
  • Technical Data mRNA manufacturing services

    Flexible, end-to-end mRNA service offering basked by decades of therapeutic manufacturing experience 
  • Technical Data Addressing challenges in mRNA drug development and manufacturing

    The rapid development and approval of COVID-19 vaccines has spurred a renewed interest in mRNA as a therapeutic strategy. An ideal platform due to the simplicity of manufacturing and robust immune response, mRNA-based drug products are being explored for use in infectious disease, protein replacement, and immuno-oncology applications, among others. Despite the advantages, challenges still exist around designing the template mRNA to properly balance the innate immune response with making a robust amount of protein, and ensuring the route of administration and vaccine form not only enable the desired therapeutic response, but also address storage and other logistical issues. This article details common challenges in the mRNA industry and explores avenues developers are researching to overcome them.
  • Video San Francisco site cell therapy capabilities video

    Overview of cell therapy development and manufacturing capabilities available at our state-of-the-art facility in San Francisco, CA
  • Whitepaper Technology transfers: Best practices for optimizing success and mitigating risk

    Whether changing manufacturing sites for scale up or passing from development to manufacturing, technology transfers are a critical process every drug must go through on its route to market. Done well, a successful tech transfer can improve productivity and efficiency, reduce program costs, optimize regulatory readiness, and accelerate time to market. Download the whitepaper to learn more about common pitfalls, best practices, and key elements to make your next tech transfer a success.
  • Whitepaper Telltale signs you’re with the wrong CDMO

    This article focuses on 10 red flags that could signal it is time to start looking elsewhere for a CDMO that can efficiently bring your project to commercialization while steering clear of potential roadblocks along the way.
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    This whitepaper identifies the key challenges faced at each stage of mAb development and provides guidance for streamlining pipeline progress of therapeutic mAb candidates, focusing specifically on the following:

    - Leveraging technology in the early stages to accelerate development while reducing risk- Scaling processes and production to match clinical and commercial demands
    - Integrating key regulatory considerations as a precursor to long-term success
    - Accelerating the start-to-finish workflow
  • Brochure Large molecule biologics

    Based on our unmatched experience with more than 1,000 molecules, including more than 50 large molecule (biologics) drug substances, Patheon pharma services brings deep scientific expertise to every challenge. We apply our comprehensive process development skills to significantly increase the batch yield and reduce processing time for your molecule. Our proven track record of scaling up biologics helps provide you with cost and time savings at every stage of development, with processes that ensure: 

    RepeatabilityReliabilityHigh quality and low cost
  • Whitepaper Implications of inaccurate forecasting on biologics drug substance manufacturing

    An Independent Executive Research Study was done by ORC International to examine how large molecule drug substance manufacturing and demand forecasting is filled with complexity. The long cycle time and short shelf life of a biologic drug substance makes it difficult to adapt the supply chain with agility, even at the earliest stages of development. As a result, inaccurate demand forecasts can have significant implications for companies developing biologics. And with less industry-wide available capacity for biologic production, it is increasingly difficult to locate capacity to respond to demand changes and ensure products achieve commercial goals. Thermo Fisher has a global network of sites with solutions to capacity issues.
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    “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. Whether biopharmaceutical companies have one candidate or 100, the directive is clear: moving quickly into FIH testing is essential. Learn key strategies for speeding time to clinic.
  • Whitepaper Biologic drug products: A 5-point strategy for building a robust CMC dossier

    Getting biological drug products to first-in-human (FIH) trials requires a deep and nuanced understanding of the scientific and regulatory challenges unique to these complex large molecule substances. Prioritizing regulatory CMC guidance and careful preparation of quality dossiers is integral to success from the very early stages throughout clinical development. This report identifies key strategies for developing a carefully executed, robust CMC dossier and avoiding common deficiencies that lead to clinical holds.
  • Whitepaper Switching delivery formats for sterile injectables

    Switching delivery formats can be an effective strategy to enhance they lifecycle of your drug. This whitepaper provides insight into the benefits and challenges of transferring a therapeutic compound from one aseptic injectable format to another, focusing specifically on the following:

    The material and process information and data needed to inform decision-makingTh...
  • Technical Data Four special fill/finish considerations for vaccine production

    Once your vaccine is ready for production, there are critical considerations needed in regard to the handling and process for fill/finish. The right choices can help ensure the stability and purity of your vaccine as well as limit unnecessary waste and cost. View the infographic for details on best practices for fill/finish.
  • Video The Road to Quality: Eliminating Supply Chain Blind Spots

    Managing the biopharma supply chain is a highly complex undertaking that is becoming ever more so as the number of new products rises and new process technologies are introduced. Moving with ease from one step to the next (R&D, production, distribution) while adhering to regulations and meeting customer demands involves managing many moving parts. It also requires managing a growing number of channels through which data needs to be sent, received, and tracked. Awareness and oversight over every activity and relationship along the continuum is critical for avoiding disruptions that can negatively influence distribution processes This presentation will provide insight into some of common blind spots that threaten supply chain quality, including: Supply chain vulnerabilities Insufficient demand signals Under-nurtured supplier relationships Supply chain network customization Attendees will learn about the measures that should be embedded throughout the supply chain, from procurement through last-mile delivery, to avoid these blind spots and build customer trust and confidence
  • Technical Data Cold chain services for clinical trial success

    This interactive infographic highlights Patheon’s capabilities for maintaining cold chain integrity across the supply chain. Utilizing our global network and expertise, our end-to-end cold chain management services can support your advanced clinical trial needs with:
    Cold chain storage and distributionGlobal CryoHubsSecondary packaging and labelingKit productionLaboratory services
  • Whitepaper Evolving solutions to optimize clinical trial decentralization

    The benefits offered by decentralized trials are driving wider adoption of this approach to clinical research. The introduction of novel solutions to facilitate adherence can support decentralized trials and mitigate potential concerns surrounding reduced patient-physician touchpoints.

    This whitepaper highlights Thermo Fisher's solutions to drive high adherence in decentralized trials.

  • Technical Data Interactive Clinical Trial Services Infographic

    This interactive infographic provides a summary of Patheon's end-to-end clinical trial service capabilities. You can click on any service line pod and it will dynamically display information related to that service line. This is inclusive of clinical supply planning and project optimization, clinical ancillary supplies sourcing and management, comparator and co-medication sourcing, cold and ultracold clinical supply chain management, global clinical packaging and labeling, storage, distribution, and clinical logistics management, and decentralized trial capabilities.
  • Whitepaper Prepping for commercialization through supply chain logistics

    With the rapid expansion of the cell and gene therapy market, innovators will require reliable supply chain solutions to enable the sage and efficient transportation of products to patients in need. 
    The following article highlights several industry challenges and key considerations as clients prepare for commercialization of advanced therapy products including:
    Ultra-low temperature controlManagement of stringent timelinesDocumentation and tracking requirementsScale-up capabilitiesCommunication strategy
  • Whitepaper Transforming CDMO partnerships through a holistic understanding of quality

    Quality is the underpinning of success in the pharmaceutical development and manufacturing industry.

    A commitment to quality is not only required to meet regulatory guidelines, it’s also foundational to:

    Accelerating time to marketReducing unnecessary riskImproving return on investmentCreating effective medicinesUltimately saving patient livesDespite its critical importance, quality is often mischaracterized, whether by conflating it with compliance, describing it as an end-of-the-line activity, or attributing responsibility to a single team.

    In fact, quality is difficult to fully classify because it’s not defined by one single activity, role, process, strategy, or outcome. Rather, it’s a combination and culmination of all these factors — plus more.

    This whitepaper takes an in-depth look at key indicators of CDMO quality, identifying tools and best practices to drive continuous improvement, strengthen collaboration, and ultimately cultivate trust.