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Our capabilities

Small molecule

                                                        API
                                                    
                                                        Oral solid dose
                                                    
                                                        Softgels
                                                    
                                                        Steriles

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Steriles

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                                                        Viral vectors
                                                    
                                                        Cell therapy
                                                    
                                                        mRNA
                                                    
                                                        Translational Services

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Innovative 360˚ CDMO and CRO services to support your aspiration to get treatments to patients faster.

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Clinical ancillary management Clinical manufacturing Clinical packaging and logistics Clinical supply demand planning, sourcing and optimization Cold Chain Cold and ultracold clinical supply management Commercial manufacturing Commercial packaging and logistics Continuous manufacturing Direct-to-patient, Depot-to-patient and Pharmacy-to-patient Engineered solutions Fill & Finish services Label services Other Predictive modeling Quick to Clinic Regulatory Smart packaging Storage Technical transfer

Expert

Anil Kane PhD MBA Audrey Kelleman Brian Kunz Chris Howell Christy Eatmon Clara Ferloni Daniel Baskind Douglas Hausner PhD Elena Gontarz PhD Harry Berlanga Iain McGroarty Jason Mieding Julie Hoffman Kevin Kane PhD Kevin Shea Laura Chamberlain Lloyd Norris Monica Commerford PhD Panteli Theocharous Paul Jorjorian Richard Snyder PhD Sanjay Konagurthu PhD Sara Sheriff Shawn Regits Staff writer Vincenza Pironti

Blog post

Tamper-evident Packaging for Clinical Supply Protection

Thermo Fisher Scientific’s patented Tamper Evident Carton provides a comprehensive answer to tamper-sealing concerns in clinical supply chains. This design eliminates the need for traditional tamper-evident labels by incorporating the carton, insert, and tamper-evident features into a single, unified package.

(12 minute read)

Staff writer

Blog post

Scaling allogeneic cell therapies: Overcoming manufacturing hurdles

Scaling allogeneic cell therapies requires overcoming unique manufacturing hurdles to achieve safe, high-volume production. This article explores key challenges and best practices to maintain quality and efficiency, making these transformative therapies more accessible to patients worldwide.

(15 minute read)

Staff writer

Blog post

Redefining acceleration of the drug development journey

In the pharmaceutical industry, getting essential treatments to patients quickly and safely demands a comprehensive approach that reduces delay, complexity and risk throughout the drug development journey. Accelerator™ Drug Development, Thermo Fisher Scientific’s 360˚ CDMO and CRO solutions, brings all those necessary services under one roof, enabling customers to achieve their goals of getting treatments to patients faster.

16 minute read

Staff writer

Blog post

What are Small Molecule Drugs?

Explore the ins and outs of small molecule drugs, including key development and manufacturing challenges, as well as their future potential in modern medicine.

16 minute read

Staff writer

Blog post

Insights from CPHI 2024: Accelerating drug development through strategic CDMO and CRO partnerships

Pharma and biotech companies are under increasing pressure due to rising competition, stricter regulations, and supply chain disruptions. In her CPHI Milan 2024 presentation, Jennifer Cannon, President of Commercial Operations at Thermo Fisher Scientific, discusses how tailored outsourcing solutions combining CDMO and CRO services can help streamline development and reduce costs across various therapeutic modalities.

12 minute read

Staff writer

Blog post

Insights from CPHI 2024: Navigating the high costs of cell and gene therapy development with flexible financial solutions

Cell and gene therapy developers face significant financial challenges that can stall critical projects. Flexible financial solutions are helping companies manage costs and advance their therapies. During CPHI 2024 Milan, Kelly Howard, Vice President of Commercial Operations for Viral Vector, mRNA, and Cell Therapy Services at Thermo Fisher Scientific, discussed flexible options available through Thermo Fisher Financial Solutions.

8 minute read

Staff writer

Blog post

Manufacturing autologous cell therapies: challenges and best practices

Manufacturing autologous cell therapies is a complex and resource-intensive process that involves unique challenges like supply chain complexity, scalability, and high costs. These therapies, which utilize a patient's own cells, require a highly personalized approach at every stage. However, by adopting best practices—such as optimizing supply chain management, implementing scalable manufacturing solutions, and staying aligned with regulatory requirements—manufacturers can enhance efficiency and reduce costs, making these life-saving therapies more accessible to patients in need.

(17 minute read)

Staff writer

Blog post

Emerging trends in cell therapy: Autologous and allogeneic perspectives

The cell therapy sector is experiencing significant growth, driven by innovations in biotechnology and increased investment in research and development. Despite the promise of these therapies, the intricate manufacturing processes for both autologous and allogeneic treatments present significant challenges. Thermo Fisher Scientific’s commitment as a manufacturing partner is to stay at the forefront of these advancements, driving innovation and ensuring the highest standards in cell therapy development and manufacturing.

10 minute read

Staff writer

Blog post

Understanding cell therapies: Key differences between autologous and allogeneic approaches

By harnessing living cells to repair, replace, or regenerate damaged tissues and organs, cell therapy offers personalized and potentially curative treatment for a wide range of conditions. As the field evolves, understanding the nuances between different types of cell therapies is crucial for professionals involved in the development and manufacturing of these therapies.

12 minute read

Staff writer

Why process development matters: Six benefits for biotech and pharma companies

This blog explores the essential role of process development in drug development and manufacturing, highlighting six key benefits that sponsors can gain by prioritizing this task.

15 minute read

Staff writer

Embracing green chemistry for sustainable API development and manufacturing

Early-stage API development, despite its inherent risks and uncertainties, is the critical period for embedding green principles. This proactive approach not only reduces environmental impact but also lays the foundation for scalable and cost-effective processes as the compound progresses through clinical phases.

9 minute read

Staff writer

Blog post

The power of partnership in small molecule discovery and development

Pharma companies can streamline their small molecule drug development by leveraging the internal synergies of a single, trusted provider for discovery resources and development and manufacturing services.

9 minute read

Staff writer

Blog post

Advancing viral vector development through Quality by Design approach

Explore more on NysnoBio's partnership with Thermo Fisher, focusing on a quality by design approach to viral vector development and manufacturing.

12 minute read

Staff writer

Blog post

Meeting biopharma challenges: An insider’s view on CDMO solutions for biologics

Maider Parikh, Ph.D., Vice President, Commercial Operations, Biologics at Thermo Fisher Scientific discusses the key biopharma challenges including meeting project timelines, navigating regulatory requirements, and ensuring supply chain reliability, and explains how advanced technologies, expertise, and strategic planning enable Thermo Fisher to address these challenges and help bring biologic products to market faster.

9 minute read

Staff writer

Tech transfer, part 2: The value of strategic partnerships in technology transfer

Strategic partnerships play a crucial role in successful technology transfers by helping to identify and mitigate process risks. A well-chosen strategic partner can preserve project timelines, overcome common technology transfer challenges, and lead to significant cost savings.

10 minute read

Staff writer

Tech transfer, part 1: Navigating uncertainty in pharmaceutical manufacturing: The critical role of technology transfer

Efficient technology transfer in pharmaceutical manufacturing helps maintain product quality, protect intellectual property, manage costs, and scale operations, thereby ensuring that companies can respond effectively to new opportunities or challenges, maintain competitive advantage, and ensure uninterrupted supply of medications to patients.

15 minute read

Staff writer

Five best practices for integrating drug substance and drug product development

Discover five best practices to consider when integrating drug substance and drug product development to optimize the efficiency and effectiveness of your approach.

9 minute read

Staff writer

CDMO quality harmonization: Ensuring consistency, reliability, and supply chain resilience

The harmonization of quality standards, procedures, and practices across sites is crucial for enhancing the resilience and efficiency of the entire supply chain and is a key driver in accelerating market entry for safe, effective therapies.

14 minute read

Staff writer

What’s hot in freeze drying? Your lyophilization questions answered

Lyophilization is a critical process in the sterile fill-finish phase of pharmaceutical manufacturing, particularly for products that require high levels of stability and a longer shelf life. The ability to transform drug products into a dry powder without compromising their structural integrity is particularly crucial for preserving the stability and efficacy of biologic products, such as vaccines, antibodies, and other protein-based therapies. Over the years, advancements in technology and process optimization have made lyophilization more efficient and reliable for a wide range of pharmaceutical applications.

15 minute read

Staff writer

Revolutionizing drug development: AI-driven solutions for solubility and bioavailability challenges

The integration of AI/ML technologies in drug development, particularly in addressing solubility and bioavailability challenges, marks a significant paradigm shift in the pharmaceutical industry. These advanced computational methods are transforming the traditional resource-intensive trial-and-error processes into more efficient, accurate, and cost-effective strategies.

12 minute read

Sanjay Konagurthu, PhD

Mastering complex small molecule APIs and formulations

Complex small molecule APIs are characterized by their intricate structures, higher molecular weights, and sophisticated delivery requirements, which pose unique challenges in their formulation and manufacturing processes.

15 minute read

Staff writer

Predictive modeling for solubility and bioavailability enhancement

Explore the challenges faced by poor solubility and low bioavailability in pharmaceutical formulation and the potential of predictive modeling to overcome these challenges.

15 minute read

Sanjay Konagurthu, PhD

The quality lever: Shaping success in CDMO partnerships

Compromising on quality can lead to detrimental impacts on both speed and cost, ultimately affecting the successful development and marketing of new therapies.

10 minute read

Staff writer

Blog post

A CDMO Partner for every Gene Therapy Manufacturing Stage

Take a closer look at the experiences of NysnoBio and bluebird bio for insight into what companies need in a CDMO partner for every stage of viral vector manufacturing and development.

20 minute read

Staff writer

Blog post

CDMO 2.0: Three pharma industry trends for 2024 and beyond

Discover three major trends expected in the pharma industry, including turning to flexible manufacturing, embracing digital enablement, and the need for CDMOs deliver transformational value.

15 minute read

Anil Kane, PhD, MBA

Blog post

Benefits of an integrated approach to viral vector manufacturing

Learn why biopharma companies choose to partner with integrated CROs and CDMOs with experience developing and manufacturing viral vectors over doing the work in-house.

15 minute read

Staff writer

Blog post

Understanding the viral vector product journey

Learn why biopharma companies choose to partner with CDMOs to leverage their innovative, integrated, and ready-to-use solutions for viral vector development and manufacturing for gene therapies.

20 minute read

Staff writer

Blog post

Exploring four patient-centric trends shaping today’s biopharma landscape

The biopharma industry is adopting a patient-centric approach to drug research, development, and manufacturing. Explore four trends shaping today’s landscape.

15 minute read

Staff writer

Blog post

Sterile injectable therapies: Changing delivery formats revolutionizes lifecycle management

The sterile injectable drug market is evolving at a rapid pace. This segment's significance cannot be understated. A closer examination reveals the intricacies of this evolving landscape, specifically in the realm of delivery formats.

8 minute read

Staff writer

Transforming clinical trial supply chain optimization through digitization

Innovative technologies such as artificial intelligence, automation, and real-time data analytics stand to revolutionize clinical trial supply planning from an efficiency, accuracy, and resiliency standpoint.

15 minute read

Staff writer

Blog post

Key Insights from CPHI Barcelona 2023

As the largest global event for pharmaceutical supply chain companies, CPHI is a microcosm of the pharmaceutical manufacturing industry. At this year’s event, the rapidly shifting pharma landscape contributed to an undercurrent of urgency. Following are some of the key takeaways.

10 minute read

Staff writer

Blog post

Inside pharmaceutical formulation development

Pharmaceutical formulation is a key aspect of drug development and helps to ensure safe, effective, and patient-friendly medications for people worldwide.

15 minute read

Staff writer

Blog post

Unlocking efficiency: Pros and cons of outsourcing your biorepository

When it comes to biorepositories, should biopharma companies insource or outsource their storage needs? This blog breaks down the pros and cons.

8 minute read

Staff writer

Blog post

Building a biorepository: Weighing the benefits and drawbacks

Biorepositories play a crucial role in collecting, preserving, and utilizing biological materials, but does it make sense to build or buy one?

8 minute read

Staff writer

Blog post

The 5 drug development phases

To be deemed a “success,” a new drug must make it through five specific phases: 1) discovery and development, 2) preclinical research, 3) clinical research, 4) FDA review, and 5) safety monitoring.

9 minute read

Staff writer

Blog post

Adherence and Accuracy: Smart packaging advances quality in clinical trials

Learn from Thermo Fisher Scientific’s head of medication adherence and biomarker measurement about data-quality implications of smart packaging and how to integrate them into clinical trials.

15 minute read

Staff writer

Blog post

In Silico Modeling: Accelerating drug development

In silico modeling, both in early development and across the product lifecycle, can streamline drug development and reduce the risks associated with trial-and-error experimental methods. Realizing the potential of the technology requires careful selection and application of in silico strategies and a deep understanding of how to interpret and derive the most valuable insights from the data.

6 minute read

Sanjay Konagurthu, PhD

Blog post

Integrated CDMO for Small Molecule Drug Development

A single CDMO partner that offers integrated API, drug product, and clinical strategy activities can streamline and accelerate small molecule drug development. Learn more.

6 minute read

Staff writer

Blog post

A collaborative approach to viral vector development and manufacturing

The development and manufacturing of viral vectors from discovery to commercialization is a complicated endeavor with several key considerations. Learn more.

9 minute read

Staff writer

Blog post

Enter the CRDMO: Reshaping drug development through CRO/CDMO integration

CRDMOs, or integrated contract research, development, and manufacturing organizations, are a trend to watch. Discover five benefits of partnering with one.

9 minute read

Staff writer

Blog post

Role of mRNA Encapsulation

mRNA must be encapsulated in different carriers/vectors, such as lipid nanoparticles, to ensure its efficient and effective delivery into target cells. Learn more.

10 minute read

Staff writer

Blog post

mRNA Purification Methods and Process

Learn more about the process of purifying mRNA, and how a CDMO partner with end-to-end mRNA purification experience can help streamline the drug development journey.

10 minute read

Staff writer

Blog post

CROs vs CMOs, and CDMOs: What’s the difference between the three?

CROs, CMOs, and CDMOs all help biotechnology and pharmaceutical companies with drug development and manufacturing, but what’s the difference between the three?

9 minute read

Staff writer

Blog post

Product and partnership quality in viral vector manufacturing: Your gene therapy depends on it

Viral vectors are inherently complex to produce at scale, requiring a laser focus on quality to ensure the efficiency, safety, targeted delivery, and scalability of the gene therapy.

7 minute read

Staff writer

Blog post

What is a CDMO and what to look for in a partner

Learn how CDMOs (contract development and manufacturing organizations) work with pharma companies, and the top considerations companies have when choosing a CDMO partner.

9 minute read

Staff writer

Blog post

Viral vector commercialization – Part 3: Specialized regulatory support

Find detailed regulatory considerations when preparing viral vectors for commercialization and best practices to address them.

7 minute read

Staff writer

Blog post

Viral vector commercialization – Part 2: Best practices in process validation lifecycle

Learn more about the robust viral vector process validation cycle, which includes various assessments and studies to ensure the safety, efficacy, and quality of viral vectors.

11 minute read

Staff writer

Blog post

Viral vector commercialization – Part 1: Tech transfer process for commercial viral vector manufacturing

Learn how tech transfers can help develop and manufacture viral vectors at scale, accelerate vaccine and gene therapy commercialization, and provide expertise.

9 minute read

Staff writer

Blog post

Patheon Translational Services Advance Cell and Gene Therapies from Research to Clinical Trials

Learn how our translational research services, housed in our San Diego facility, can take cell and gene therapies from preclinical to clinical.

6 minute read

Richard Snyder, PhD

Blog post

Top tips for providing the right amount of detail in first-in-human common technical documents

In the early-development stage, little may be known about a drug’s characteristics. What’s more, drug processes and formulations frequently evolve as more information emerges following testing and trials. Learn more.

5 minute read

Staff writer

Blog post

Enabling a digital culture through integrated business processes

In contrast to a physical work environment, where stability and experience are key, a digital business environment focuses on innovation and connectivity. Learn more.

4 minute read

Staff writer

Blog post

Delivering on the promise of cell and gene therapies: A patient-centric approach

8 minute read

Staff writer

Blog post

Gaining a deeper understanding of your API

As active pharmaceutical ingredients (APIs) become increasingly complex, they pose potential formulation problems that can extend timelines and explode budgets. Read this blog to learn more.

5 minute read

Staff writer

Blog post

EU and US regulations: What’s coming for cell and gene therapies?

Cell and gene therapy (CGT) developers today face an added challenge in their quest to bring a product through clinical trials and to the market. Read this blog to learn more.

7 minute read

Staff writer

Blog post

Choosing a CDMO for mRNA success: Five CDMO characteristics needed

The promise of mRNA technologies has been clearly demonstrated during the COVID-19 pandemic, with vaccines reaching the market in record time. The vital role...

7 minute read

Staff writer

Blog post

Trends in mRNA therapeutics: Pandemic learnings for a pathway to success

The rapid advancement of the Pfizer-BioNTech and Moderna messenger RNA–based COVID-19 vaccines from lab to clinic—with development taking less than one year—has validated the...

5 minute read

Staff writer

Blog post

Moving from vials to prefilled syringes for vaccines: Three key success factors

As pharmaceutical companies become more patient-centric and self-administration of injectable drugs continues to increase, the market for drug products in prefilled syringes is forecast to grow, reaching $9.53 billion by 2026.

4 minute read

Staff writer

Blog post

The Four Stages of Equipment Qualification

As discussed in my previous blog, qualification is the process of establishing documented evidence that a specific equipment, facility or system are fit and ready for their intended use.

3 minute read

Staff writer

Blog post

Myths & Facts about Ancillaries

It’s a fact that ancillary supplies are frequently perceived as less important than study drug.

2 minute read

Staff writer

Blog post

Is Your Supply Chain Bulletproof?

Before you respond, think hurricanes, Nor’easters and tsunamis. Earthquakes, typhoons and volcanic eruptions. Civil unrest and war. Terrorism. A pandemic virus.

2 minute read

Jason Mieding

Blog post

Top Tips on How to Manage Clinical Label Translation and Regulatory Requirements

Wouldn’t it be nice to find a way to stay on top of label translation and regulatory requirements for every country included in your clinical trial?

2 minute read

Kevin Shea

Blog post

Introducing an Expanded Packaging Service for Specialty Products

Developing a specialty drug for a complex or rare disease is an achievement worthy of celebration.

2 minute read

Staff writer

Blog post

Is it Time to Start Thinking about Packaging?

If this headline caught your eye, it may be because you’ve received promising pre-clinical results (Congratulations!) and you’re starting to think about planning your next steps.

2 minute read

Chris Howell

Blog post

Taking Your API to the Next Level: Three Steps to Consider Before Outsourcing

With outsourcing API development becoming more common, we see a rise of multiple competing Contract Development Manufacturing Organizations (CDMOs) as potential development partners.

10 minute read

Laura Chamberlain

Blog post

Break Through the OTC Noise

It’s no secret—consumers have a vast range of OTC options at their favorite in-store or online retailer. Everything from tablets and capsules, to syrups—consumers have more options than ever in the OTC jungle.

8 minute read

Staff writer

Blog post

Considerations and roadblocks that stifle orphan drug development

According to the US Food and Drug Administration (FDA), “2020 was a record-breaking year in terms of the number of orphan drug designation and rare pediatric disease designation requests submitted to the Office of Orphan Products Development.”

6 minute read

Christy Eatmon

Blog post

Regulatory landscape in Europe: Key advice for meeting post-Brexit Qualified Person requirements

The United Kingdom’s (UK) departure from the European Union (EU) has added a layer of complexity to the clinical trial supply chain in Europe above and beyond COVID-related disruptions.

(4 minute read)

Staff writer

Blog post

Time to embrace electronic labels? Potential labeling solutions under the new EU Clinical Trial Regulation

The new EU Clinical Trial Regulation (CTR) is intended to simplify clinical trial administration and create a more welcoming climate for pharmaceutical companies that operate in Europe.

5 minute read

Kevin Shea

Blog post

Navigating the Complexities of Process Performance Qualification

Method qualification is monumentally important before process performance qualification (PPQ). This early assessment of your method’s performance characteristics is critical as it pertains to method validation and its parameters such as precision, accuracy, and linearity.

5 minute read

Elena Gontarz, PhD

Blog post

Continuous Manufacturing: An Efficient Way to Produce OSD Drugs

When Henry Ford revolutionized manufacturing practices back in 1913 in Highland Park, MI, his main goal was simple—to make the best possible product in the most efficient and cost-effective manner. Ford’s focus on bettering the “flow” of manufacturing to enable workers/technology to work smarter and reduce waste of raw materials, changed manufacturing principles forever.

6 minute read

Douglas Hausner, PhD

Blog post

Simplifying Your API's Development Journey

The primary way new drugs are developed is changing. Historically, pharma companies—particularly large pharma companies—have developed APIs in-house.

7 minute read

Audrey Kelleman

Blog post

COVID-19’s Silver Lining: Accelerated Vaccine Development

Vaccine development is a lengthy process—it is expensive, attrition is high, and to get a licensed vaccine to everyone, it takes multiple candidate iterations. Vaccine development for pandemics and epidemics is risky, and due to the novel nature of viruses, certain unknown factors can derail a vaccine program.

6 minute read

Staff writer

Blog post

A Day in the Life of a Viral Vector Partner

When it comes to a viral vector Contract and Development Manufacturing Organization (CDMO), what sort of qualities should they possess?

9 minute read

Staff writer

Blog post

How Decentralized Clinical Trials Enhance Patient-Centricity in the Age of COVID-19

As COVID-19 continues to change how we do business in the biopharmaceutical industry, it’s important to not lose sight of why we do what we do: improving and saving patient lives.

5 minute read

Jason Mieding

Blog post

Work Smarter, Not Harder: Accelerating Your Biologics Development and Commercialization

Over the past decade, the biologics industry has seen double digit growth and an overall increase of market share.

5 minute read

Paul Jorjorian

Blog post

Prefilled Syringes: Three Pain Points You May Not Have Considered

As pharmaceutical companies look to become more patient-centric, certain drug products come to the forefront to support that effort.

5 minute read

Staff writer

Blog post

Navigating Cell & Gene Therapy Regulations: How Does Your CDMO Match Up?

Whether you are a large or new and emerging biotech company, many companies find themselves lacking the internal resources and/or expertise to properly support regulatory submissions.

7 minute read

Staff writer

Blog post

Choosing a CDMO Who is a True Bioproduction Expert

With the number of CDMO’s rising in the biologics manufacturing industry, it can be challenging for new and emerging biopharmaceutical companies to determine which CDMO is right for them.

8 minute read

Elena Gontarz, PhD

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