21 Mar 2023

Continuous Manufacturing- What's Driving Adoption?

CDMO’s accelerating adoption Reshoring: CM can help when competing with Asian producers on price. Government investment during Covid to protect against supply chain issues & increased focus on critical drugs supply New guidance based on GMP - ICH Q13 will likely see smaller companies deciding to use CM Opportunities for generic manufacturers – cost savings, beyond production efficiencies Moderator: Wayne Weiner, Principal, Pharmatech Solutions LLC Panellists: Bikash Chatterjee, CEO, Pharmatech Associates- A USP Company Graziano Castaldi, President/CEO, Chemelectiva Kai Donsbach, Professor, Virginia Commonwealth University William A. Hein II, Senior Director Technical Operations Small Molecule Platform, Janssen

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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. (72)

  • 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.
  • 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 North America 2023 – From the Floor

    Follow along for live updates from the Content team as we bring you the latest from CPHI North America 2023 - from session talks, panel discussions, interviews, and more, there's a lot to discover with CPHI Online at the Pennsylvania Convention Center! 
  • Brochure From Molecule to Medicine

    One integrated partner for every step of your drug development journey.
  • News Thermo Fisher Scientific sponsors lab facility to support emerging biotechs

    To assist with the growth of the biotechnology industry and support newly emerging biotech companies, Thermo Fisher Scientific have made the move to be a founding sponsor of Momentum Labs in Alachua, FL, USA. 
  • Brochure Growing your biopharma

    Ten questions you're likely to face from investors and how to respond to them.
  • News Thermo Fisher Scientific expands with state-of-the-art facility in China

    Thermo Fisher Scientific are to open a new cGMP facility in China, including the latest technology so that they can assist in the accelerated provision of medicines to patients. 
  • 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.

  • News New CPHI report looks at CDMO outsourcing and partner selection

    In The Future of Outsourcing - Strategies for Partner Selection, experts from across the pharma industry look at current trends impacting the contract services landscape and gauge the merits and drawbacks of the most common outsourcing strategies in use

  • Brochure Brochure: Quick to Care™ Program

    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.
  • 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 Pharma Services' scientific innovation and investments

    Simplifying and accelerating your journey to market by providing the end-to-end solution you need.
  • 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 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.
  • 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 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
  • 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.
  • 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
  • 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
  • News Thermo Fisher buys Novasep viral vector manufacturing business

    Expanded global capacity addresses growing demand for cell and gene therapy
  • Technical Data Maintaining the cold chain in European distribution

    High biologics growth in Europe fuels the need for cold chain management. Check out this infographic to learn top tips on how to maintain cold chain integrity across the European supply chain, from molecule to medicine.
  • 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
  • Technical Data cGMP plasmid DNA manufacturing services

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

    Combining technical expertise with agile execution to address your unique cell therapy project needs 
  • 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.
  • 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.
  • 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
  • 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 The Future of Outsourcing – Strategies for Partner Selection

    How can innovators select the right outsourcing partners to work with their in-house teams? This report will examine current outsourcing strategies, and assess which approaches work best for specific products, and for particular development/manufacturing pathways. In a market where CDMOs and development partners are in incredibly high demand, this report considers current market trends, the changing development goals for biotech and pharma, and how outsourcing strategies are now evolving. Calling on market experts from across the outsourcing sector, this report will collate expertise for a comprehensive overview of the manufacturing, outsourcing, and partnering landscape.
  • Whitepaper mRNA vaccine development: Key insights for planning, workflow, and supply chain success

    In this report, we will review key insights derived from the development of mRNA-based COVID-19 vaccines and how they can be applied to accelerate progress in the manufacture of mRNA vaccines and therapeutics moving forward, focusing on the following:
    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.
  • 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.
  • 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

    Learn how Thermo Fisher is meeting its environmental sustainability goals, and how we work in partnership with the pharma and biotech communities on shared environmental sustainability goals.
  • Whitepaper EU Clinical Trial Regulation 2022_ Understanding the impact on clinical research in Europe

    Eight years after its adoption, the EU Clinical Trial Regulation (CTR) 2022 has come into full application, radically altering the regulatory landscape for conducting clinical trials in EU member states and European Economic Area (EEA) countries. This whitepaper provides insight into the key changes introduced by the regulation and guidance for managing anticipated challenges, focusing specifically on the following considerations:

    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
  • Whitepaper Decentralized Clinical Trials in the EU

    The COVID-19 pandemic accelerated the adoption of DCTs worldwide, but the rate of uptake has not been consistent globally. Some early implementation barriers, including immature digital infrastructures and sponsors’ limited experience with the approach, have been steadily receding as enabling technologies become more prevalent and knowledge of benefits grows. Other obstacles, such as the perception of regulatory barriers, are more challenging to navigate, especially in the EU, where EMA recommendations are not interpreted consistently across countries.

  • Whitepaper CGT_Cell and gene therapies in the US vs. the EU Top five areas of differentiation

    In this eBook we share the five key differences in the drug development and review process for companies hoping to gain market access through US Food and Drug Administration (FDA) or European Medicines Agency (EMA) approval—as well as tips for navigating these differences.
  • 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
  • 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 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...
  • 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 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 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 Targeting cancer with therapeutic antibodies: Solutions for every phase of mAb development

    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
  • 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.
  • 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.

  • 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 Bringing Innovative Therapies to Market Through an Enhanced Integrated Approach

    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 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
  • 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
  • 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
  • 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
  • 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
  • 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?
  • 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.
  • 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
  • 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
  • Webinar 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.
  • Webinar Covid Therapeutics Outlook

    Focus on Medicines for All's work in process improvements for COVID therapeutics, including work done thus far on remdesivir and molnupiravir. The session will also describe how Medicines for All shares its results with the global market and how this has led to uptake of its processes on critical COVID drugs. The Medicines for All Institute (M4ALL) is part of Virginia Commonwealth University; M4ALL is committed to improving access to high-quality medications across the globe by driving down production costs. M4ALL does this by optimizing active pharmaceutical ingredient (API) production and providing access to manufacturers around the world to enhance the security of medicine supply chains. This session was broadcast as part of the CPHI North America show.
  • Webinar Form and fit: Mobilizing integrated resources to transform complex small molecules into high-performing drugs

    As clients seek to gain maximum benefit from each clinical stage, the advantages offered by contract partners with integrated services are making these higher returns tangible. This presentation will highlight key activities under Thermo Fisher’s integrated drug substance and product development services for the clinical development of small molecule APIs that decrease development risk, decrease timelines, and enable success in Phase 1 and beyond. This session was broadcast as part of the CPHI North America show.
  • Webinar Novel Excipient Pilot Program Review

    In this webinar, originally broadcast as a part of Pharmapack Europe 2022, speaker Nigel Langley, Director Technical Service & Scientific Affairs, BASF Pharma Solutions reviews the 'Novel Excipient Review Pilot Program'. Launched at the end of 2021, the voluntary Novel Excipient Review Pilot Program (Pilot Program) allows excipient manufacturers to obtain an FDA review of certain novel excipients before their use in drug formulations. Fundamental to the creation of the program, IPEC Americas talks us through the historical challenges that led to this first-in-kind program and an update from the FDA on the first four excipients approved in the pilot and what this means for the future of excipient manufacturing.
  • Webinar Optimized Approach to Drug Development

    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.
  • Webinar CPHI Webinar Series Parenteral Drug Market: Meeting Escalating Challenges

    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