Bio/Pharma Analytical Solutions

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Analytical solutions for all your bio/pharmaceutical workflows

From drug discovery and development, through the clinical testing phase and on to bioproduction and QA/QC, we offer comprehensive workflows and LC-MS based innovative technologies to confidently answer your analytical questions, bringing new life-changing biotherapeutics to market faster than ever before.

Early discovery and research

High-throughput capabilities and advanced versatile tools to aid the search for pipeline candidates during early development phases.

Product characterization

Advanced analytical tools to answer in-depth molecular questions with full confidence.

Process and analytical development

Robust and reproducible analyses to monitor molecular attribute changes with speed and confidence.

Quality control and manufacturing

Reproducible, robust, GMP compliance-ready methods to ensure the release of safe and effective products.


Industry insights

Emerging applications continue to shape the future of pharmaceutical analytical workflows, from novel therapeutic classes like GLP-1s to heightened regulatory demands around contaminants such as PFAS. This section highlights the trends redefining how scientists are improving speed, precision, and compliance across the drug development lifecycle.

GLP-1

Therapeutic peptides, a class of pharmaceutical products made up of amino acids, have gained significant attention for their potential in treating a variety of diseases. With over 100 approved peptide medications worldwide, including the best-selling semaglutide for type 2 diabetes and weight management, the development of these drugs is rapidly expanding. However, challenges in production, including the identification and control of peptide-related impurities, have driven advancements in analytical technologies like Liquid Chromatography coupled with HRAM mass spectrometry for improved quality control.

Confident and sensitive identification of semaglutide degradation products and impurities using a UHPLC-HRAM MS platform

This application note shows the capabilities of both Thermo Scientific Orbitrap Exploris 240 Mass Spectrometer and Thermo Scientific Vanquish Flex UHPLC system for identifying semaglutide degradation products and impurities.

Enhancing GLP-1 analysis: Accurate impurity detection and detailed structure elucidation

This flyer highlights that therapeutic peptides, composed of structured amino acids, are widely used in medicine. Over 100 are approved globally, including semaglutide for diabetes and obesity. As patents expire, companies are developing generics, driving new innovations.

PFAS

PFAS (per and polyfluoroalkyl substances) play a complex role in pharmaceutical packaging. Valued for durability and resistance, they are commonly found in coatings, seals, and container linings. However, their persistence in the environment and rising regulatory scrutiny have put them in the spotlight. This section shares industry insights on PFAS in pharma packaging, covering detection, compliance, and safer alternatives, helping manufacturers and suppliers stay ahead of evolving standards while protecting product quality and patient safety.

Comprehensive PFAS screening in pharmaceutical packaging and medical devices

Discover advancements in therapeutic peptides and production challenges in our webinar. Learn how liquid chromatography with HRAM mass spec helps control impurities for safer medications.

Comprehensive PFAS screening in pharmaceutical packaging and medical devices by LC-HRAM-MS

This application note shows how LC-HRAM-MS enables sensitive, simultaneous targeted and non-targeted PFAS screening in pharmaceutical packaging and medical devices, detecting known and unknown contaminants.

Advancing PFAS Detection in Pharmaceutical Manufacturing with LC-HRAM-MS

Discover how advanced LC-HRAM-MS technology enhances PFAS detection in pharmaceutical manufacturing, ensuring higher sensitivity, accuracy, regulatory compliance, and product quality.

Bioanalysis for oligonucleotides

Bioanalysis is crucial for oligonucleotide therapeutic drug development as it enables the precise measurement of drug concentrations and their metabolites in biological matrices. This is essential for understanding the pharmacokinetics, pharmacodynamics, and safety profiles of these therapeutics. Accurate bioanalytical methods ensure that the drug's absorption, distribution, metabolism, and excretion (ADME) properties are well-characterized, facilitating dose optimization and efficacy assessment. Additionally, bioanalysis helps in monitoring potential off-target effects and immunogenic responses, thereby ensuring the overall safety and effectiveness of oligonucleotide-based therapies.

Sensitive LC-MS/MS quantitation of antisense oligonucleotides in plasma using the TSQ Altis Plus mass spectrometer

Bioanalysts have long relied on triple quadrupole technology for its speed, sensitivity, and reliability. Learn to accurately quantitate fomivirsen and nusinersen in human plasma matrix.

Sensitive quantitation of antisense oligonucleotides in plasma using high-resolution, accurate-mass (HRAM) mass spectrometry

Discover how to easily develop a sensitive, selective, and reproducible quantitation method for antisense oligonucleotides in human plasma using IPRP-LC-HRAM-MS.


Case studies

Thermo Fisher Scientific provides technology innovations to support biopharmaceutical companies of all sizes–our workflows are leveraged by major manufacturers like Pfizer and Merck, as well as innovative research organizations like LifeArc, Bio-Techne Corporation, and NIBRT.

 

“Many of our academic collaborators have been using Orbitrap technology to aid their research for years, now it is great for us to apply it to both our biopharmaceutical and small molecule programs to accelerate their progression,” said Dr. David Tickle, Senior Principle Scientist, LifeArc.

Characterizing Therapeutic Proteins for Drug Discovery and Development

Discover how LifeArc leveraged Thermo Fisher Scientific solutions to drive protein-based drug discovery.

Case study: Deploying MAM across sites at Pfizer

Case study: Deploying MAM across sites at Pfizer 


Applications

Thermo Fisher Scientific offers a superior portfolio of fit-for-purpose solutions to meet your drug development and drug release needs with compliance in mind. Our solutions include cutting-edge mass spectrometry, reliable LC, GC, and IC separation, as well as high-throughput instruments designed for routine analysis.

 

Behind every instrument is SMART software designed to make life easy for you, whilst maintaining compliance to answer your most difficult analytical questions faster for a broad range of pharmaceutical applications.


Resources

Are you looking for more details on how Thermo Fisher Scientific solutions are accelerating biotherapeutic time-to-market? Check out these resources for more information on our workflows and technologies.

Featured resources


For Research Use Only. Not for use in diagnostic procedures.