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Brochure
27 Jun 2024

Brochure: Quick to Care™ Program

PDF 6.2 MB

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.

Content provided by our supplier

Thermo Fisher Scientific Inc.

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

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  • Technical Data CDMO + CRO integration: Transforming the pharmaceutical value chain for emerging biotechs and large pharmas

    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 CPHI Barcelona 2023: Tackling the Pharma Talent Precipice – Part 2

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  • 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.
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  • 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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  • Video Greening the Supply Chain: A Guide to a Sustainable and Renewable Supply Chain

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  • News Thermo Fisher Scientific sponsors lab facility to support emerging biotechs

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  • Video Enabling Industry Consensus and Action for Sustainable Drug Delivery Devices

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  • Video Fireside Chat: Sustaining Progress through Uncertainty: Navigating the Unknown

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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.

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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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    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

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    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.

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    Click here to register

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  • Webinar Managing Outsourcing Relationships to Optimise Manufacturing Operations

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  • Technical Data cGMP plasmid DNA manufacturing services

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  • 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
  • Brochure Large molecule development and manufacturing

    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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    - 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
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    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.
  • 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. 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
  • Video Optimizing ADC Processes: Advanced Strategies with High-Quality Bioreagents

    Ensuring accurate potency testing and maintaining product purity are crucial in antibody-drug conjugate (ADC) development, scale-up, and commercialization. Innovative solutions, including effective tools and streamlined processes, are necessary for efficient production of ADCs for clinical trials and commercial launches. Reagents such as dehydroascorbic acid (DHAA) and tris(2-carboxyethyl phosphine) (TCEP) play vital roles in conjugation chemistry, enabling efficient and precise antibody-drug conjugation. This presentation will explore leveraging CGMP grade materials and a trusted supply chain partner to help teams achieve the highest quality outcomes for ADC their projects to overcome challenges in potency testing and product purity.
  • Video Pharma’s Innovation Catalyst: How Partnerships, Investments, and Acquisitions Are Shaping Healthcare's Future

    Pharma is often perceived as lacking innovation outside its core R&D operations. However, the venture capital arms of major pharmaceutical companies play a crucial role in driving innovation and tackling significant healthcare challenges. Join this panel discussion to gain the latest insights into the current investment and acquisition dynamics within the pharmaceutical industry.
  • Video Panel: Digital Health in Pharma: Revolutionizing from R&D to Patient Care

    Discover how digital health is transforming the pharmaceutical industry. Explore the expanding role of technology across the pharma value chain and its implications for the future
  • Video Maximizing Outsourcing and Manufacturing Success Through Strategic CDMO and CRO Partnerships

    The evolving landscape of the pharmaceutical industry, marked by significant breakthroughs in advanced treatments and relentless pressures for speed and innovation, has fundamentally transformed the role of Contract Development and Manufacturing Organizations (CDMOs). As the industry faces challenges from supply chain disruptions, regulatory shifts, capacity deficits, and cost pressures, CDMOs are increasingly operating as strategic partners who play a critical role in helping to bring new therapies to market through innovative service models and customizable solutions across different scales and modalities.
    Attendees will gain insight into the evolution of CDMOs from transactional service providers to essential collaborators, enabling biotech and pharmaceutical companies to streamline the path to Investigational New Drug (IND) submission, optimize their supply chains, reduce risks, and accelerate the development and commercialization of new therapies to market.
    Discussion points include: Leveraging integrated CRO/CDMO capabilities and a robust global network for enhanced stability, flexibility, and reliability in uncertain times Dynamic scaling and pivoting of operations in response to market shifts, global health crises, and changing business models Driving innovation and efficiency with advanced technology platforms and collaborative project management Navigating complex regulatory landscapes to comply with changing global standards and market access requirements Future-proofing manufacturing processes through adaptive strategies"
  • Video Development and Validation of Automated Rapid Protocols to Ensure Mycoplasma-Free Biologics

    Testing for Mycoplasma is essential to ensure safety of biopharmaceutical products. With over 200 recognized species, Mycoplasmas are common contaminants in manufacturing facilities and cell-derived biologics. Existing compendial methods are complex and lengthy. PCR-based methods, while faster, can be limited in sensitivity. To overcome these challenges, we have developed novel protocols based on the Applied Biosystems™ MycoSEQ Plus quantitative PCR method combined with automated DNA extraction. Our protocols were validated with live Mycoplasma species to meet regulatory requirements. The sensitivity, sample volume and turnaround time surpass compendial culture method results. Our testing protocols are suitable for testing a variety of samples, including raw materials & final products, samples that interfere with traditional culture and PCR method, and complex samples such as cell and gene therapy products.
    This session discusses how our new testing protocols can benefit biologics companies and help accelerate the manufacturing process for cell and gene therapies.
  • Video Panel: Pharma Manufacturing in Emerging Markets - Towards Localisation in Africa?

    Africa stands at the cusp of unprecedented growth, offering a wealth of opportunities for strategic partnerships and investment.  Unprecedented momentum in catalytic initiatives for ecosystem development offer potential for unlocking aggregate commercial opportunity greater than $20Bn.  By fostering collaborations between global health actors, local institutions, investors, and international companies, Africa can harness its vast potential. Join us as we explore opportunities that Africa can offer to the Global Pharma Industry  Establishing strategic partnerships between local institutes, investors and international companies  Initiatives around regulatory capacity, local infrastructure and value chain to help attract foreign investment
  • Video Navigating Shifts in CDMO-Pharma Relations: Trends and Implications

    The recent acquisition of Catalent is driving significant transformation in the CDMO space within the pharmaceutical landscape. This shift has led CDMOs to expand beyond manufacturing, incorporating development services into their offerings. This evolution is redefining their role in the supply chain, providing integrated solutions that boost efficiency and foster innovation. At the same time, larger pharmaceutical companies entering the CDMO sector are changing market dynamics, increasing competition, and diversifying service offerings. Why traditional CDMOs are broadening their scope by taking on development roles alongside manufacturing, reshaping their role within the pharmaceutical supply chain. Assessing the impact of larger pharmaceutical companies entering the CDMO sector, and the resultant shifts in market dynamics, competition, and service offerings. Reviewing the evolving relationships between CDMOs and Pharma, and what it means changing landscape.
  • Video Harnessing Digital Twins for Enhanced Aseptic Manufacturing Processes

    Explore the use of digital twin technology to simulate pharma manufacturing processes, allowing for optimization of processes, scale up, faster validation and training for faster to market and without risking actual production and quality. We scratch the surface of what it takes in respect to digital technologies, the complexity and some of the barriers that is still missing to unlock the hype in pharma. Rooted in some use cases we look into some of the value drivers and where Novo Nordisk see some of the challenges – e.g. when to interact with authorities, do we have sufficient guidelines and building trust of digital models.
  • Video A Case Study with Roche on the Integrated Continuous Manufacturing of Pharmaceuticals

    A new drug substance and drug product production route using integrated continuous manufacturing has been developed for a Roche drug. This new manufacturing process successfully addresses supply chain constraints and patient needs, reducing the lead time from 15 months down to 50 hours. Equivalent yield, and greater purity Production costs reduced by 37% 400% smaller carbon footprint
  • Video Enhancing Cybersecurity: What Pharma Can Learn From an Intelligence Agency

    A talk with a cyber security professional, sharing valuable insights gained from a career in the UK intelligence community. A look at the potential threats that the pharmaceutical industry faces and how risks can be mitigated. Including an introduction to the complexities of using AI securely.
  • Video Leveraging AI for Knowledge Management in Pharmaceutical Development: The iQNow Experience at Boehringer Ingelheim

    During pharmaceutical product development, Boehringer Ingelheim generates hundreds of thousands of documents, each containing valuable knowledge and problem-solving strategies. The challenge is to make this knowledge accessible within the company to avoid redundant efforts. To address this, Boehringer Ingelheim developed iQNow, an AI-supported knowledge management system. iQNow employs various methods and technologies, with AI playing a crucial role, to deliver the right knowledge to the right person at the right time in a scalable, efficient, and universal manner. The introduction of GPT technology has been transformative for iQNow. In just nine months, the user base has grown to 26,000, and the system has enabled the reallocation of over 700,000 work hours to more productive activities. In this conference, we will provide insights into the iQNow system and share our experiences of implementing AI in a large company. Join us as we explore the intersection of AI and innovation within the context of pharmaceutical development in Germany.
  • Video Deep Dive: Navigating Data Compliance Standards in Pharma

    Pharma thrives on innovation but requires strict regulations for safe and effective drugs. In today's age, navigating compliance for complex new technologies, drug manufacturing and patient safety adds to the challenge. How compliance management systems such as digital documentation can reduce errors and enhance consistency processes. What does efficient auditing look like and how to achieve it Insights into efforts towards regulatory harmonization and its impact on international manufacturing and market access
  • Video Fireside Chat – Navigating Outsourcing Partnerships for Start-Ups

    Join our session on navigating outsourcing partnerships for start-ups, where we'll explore effective strategies and best practices for collaborating with external partners to accelerate growth and innovation. Learn how to leverage outsourcing to optimize resources and drive success in your startup journey
  • Video The Future of Pharma Manufacturing

    Join our opening keynote and gain insights into emerging trends, sustainability initiatives, and the transformative potential of Industry 5.0. This session will explore what the future looks like for pharma manufacturing.
  • 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.