Spectroscopic, rheological, extrusion and X-ray solutions for pharmaceuticals

Guided by pharmacology and clinical sciences, and driven by chemistry, pharmaceutical research plays a crucial role in the development of pharmaceuticals. From the stages of drug development to marketing and post marketing,  a plethora of analytical techniques are used for the investigation of bulk drug materials, intermediates, drug products, drug formulations, impurities and degradation products, and biological samples containing the drugs and their metabolites, with an aim to understand the physical and chemical stability of the drug, the impact on the selection and design of the dosage form, the stability of the drug molecules, and the quantity and identity of the impurities, amongst others.

Our wide range of solutions are an important resource to quickly and accurately monitor your drug as it moves through the development workflow but also enables quality and regulatory compliance through the drug formulation, development and manufacturing processes. 

Our solutions empower you to quickly confirm the safety of your drug at every stage of development using the following techniques:

  • Spectroscopy instruments and software
  • Extrusion and rheological tools
  • X-ray diffraction
  • Ultraviolet-visible and visible spectrophotometers
  • Service and support

And more!

Contact us

Featured brochure
Safely accelerating drug development for brighter outcomes

Safely accelerating drug development for brighter outcomes

Learn more about our wide range of range of spectroscopy and materials characterization tools – from Compounding, Rheology, FTIR, NIR, Raman, UV-Vis to XRD techniques.

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Pharmaceutical workflow

Early research in preclinical drug development is a complex process that involves understanding the underlying disease mechanism, identifying the therapeutic target, and enabling the selection of promising molecules as drug candidates. The most important element of the early discovery process is to select the best new molecular entities to enter clinical trials and to limit failure in full development. The priority during the preclinical selection process is the safety and efficacy testing of a new molecular entity, which is important for small chemical molecules and biotherapeutic compounds alike.

Webinars
Improving Quality of Bacterial Culture and Oligo Nucleotides with UV/Vis Spectroscopy to Accelerate mRNA Vaccine Production
Bacterial growth rate influences gene expression by acting on both sides of the mRNA equilibrium: synthesis and degradation. Discover how the Thermo Scientific GENESYS and Evolution series UV/Vis spectrophotometers can be used to evaluate and achieve optimum bacterial culture growth rate and measure oligonucleotide quality to ensure vaccines produced are not contaminated.
  Watch webinar

From preclinical samples to clinical phase supply, this stage involves pilot-scale development of the drug, addressing analytical methods, process chemistry, process development and optimization, and approaches for scaleup. Early development also encompasses the formulation process to assess the best composition and compounding method of the API and other excipients for safe, timely, and effective delivery to the therapeutic target.

Webinars
Biodegradable Long-acting Injectable Implants Prepared by Hot Melt Extrusion
InnoCore Pharmaceuticals shares their experiences on how to prepare long lasting implants using hot melt extrusion (HME), an overview and applications for injectable implants, and what to consider when choosing polymeric matrices for drug delivery systems.
   Watch webinar
Effective Imaging for Identification and Sizing API Domains
The distribution of API in a pharmaceutical tablet is a critical factor in developing drugs that are effective when consumed. The combination of FTIR and Raman spectroscopy with mapping is well-suited for identifying and sizing API domains. Both techniques provide excellent chemical and spatial information about the distribution and concentration of the API in a tablet.
  Watch webinar
Predicting the Crystalline Nature of APIs with a Novel In-line X-ray Technique: InsituX
University of Rouen Normandy discusses how the precise identification of solid phases and their crystallinity are important for the design of drying, the storage conditions, and the repeatability of the solid transformations regarding APIs, as well as the identification of non-stoichiometric solids and the possible presence of polymorphs of hydrates and anhydrates.
  Watch webinar
Improving Solubility with Hot Melt Extrusion (webinar series)
Explore this webinar series on improving the solubility of APIs with HME by creating solid dispersions. This series covers: solid dispersion: a supersaturable formulation to improve bioavailability of orally administered APIs; enabling strategies for development of HPMCAS-based amorphous solid dispersion by HME; a closer look into ASD formulations: a tale of two solid dispersions
  Watch webinars

Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs. Reliable analytical methods, on-line and off-line, are necessary to develop a robust, well documented and safe process that can be registered with regulatory bodies. Scalable manufacturing unit-operations, such as granulation and hot melt extrusion can be used to tailor production output to market demands.

Webinars
Lean Manufacturing Practices with Raman Spectroscopy for the Biopharmaceutical Production
Learn about the role of Raman spectroscopy in the rapid release of raw materials through identity testing and real-time release testing of final products such as vaccines, hormones, and monoclonal antibodies.
  Watch webinar
Advances in Twin-screw Granulation Technologies
Review the basic concept of TSG, discuss the influence of process parameters on final product quality, and provide insights into recent advances in TSG continuous manufacturing.
  Watch webinar
NIR to the Rescue: Production Efficiency and Cost Savings for Pharma
Reducing costs and improving efficiency have always been a goal, but these needs are increasingly critical for pharmaceutical companies. This webinar will highlight NIR’s incredible capabilities across a variety of drug forms, in regulatory compliance, for GMP environments, and more.
  Watch webinar
Injectable Implants: Manufacturing Advanced Medicines with Hot Melt Extrusion
Injectable implants offer several advantages as drug delivery systems including site-specific release and high patient compliance. Hot melt extrusion (HME) is an ideal method to manufacture as scalable from early R&D to commercial manufacturing and can be done in a continuous manufacturing environment. Watch this webinar for an overview of implant types, materials, and scale-up from development to full-scale manufacturing.
  Watch webinar
Capable and Compliant XRD in Pharmaceuticals
X-Ray diffraction (XRD) offers valuable analytics in pharmaceuticals quality control. Its non-destructive nature and relatively easy sample preparation benefit all users. Learn about guidelines not only for sample preparation but also different measurement strategies while complying with even the most recent regulatory requirements.
  Watch webinar
Improve Efficiency and ROI by Adopting Molecular Spectroscopy Techniques in Pharma Manufacturing
Discover the differences between FTIR, NIR and Raman spectroscopy, learn how spectroscopy is applied in quality control labs and hear how implementation of these techniques increased efficiency and minimized costs.
  Watch webinar

Compliance is much more than Title 21 of the U.S. Code of Federal Regulations (CFR). It is a function that demonstrates and documents the quality of a pharmaceutical company’s processes and products. We need to understand the FDA’s current expectations to maintain Good Manufacturing Practices (GMPs) or specific regulatory requirements such as European Commission (EU) Annex 11. Having reliable software with your instrumentation that supports you with the ever-evolving emphasis on data integrity, security, compliant storage, and documentation can make a difference in driving your business benefit.

Webinars
Quality Assurance and Data Integrity from an Auditors’ Viewpoint
In this on-demand webinar, you will hear directly from industry auditors as they discuss the current regulatory framework for good manufacturing practice (GMP), including data integrity, validation and qualification for computerized systems in regulated laboratories.
  Watch webinar
Patheon Experience: Overcoming Challenges to Ensure Data Integrity and Standardization
Learn how and why Patheon Pharma Services implemented both FTIR Spectroscopy and a Chromatography Data System in different areas of their workflow to meet data integrity needs and the importance of these to the business.
  Watch webinar
Instrument Systems take on Burden of Compliance
Hear how two different instrument platforms – FTIR and Microvolume UV-Vis – help labs assure compliance in their processes for manufacturers in pharmaceuticals and other related industries.
  Watch webinar

Early research in preclinical drug development is a complex process that involves understanding the underlying disease mechanism, identifying the therapeutic target, and enabling the selection of promising molecules as drug candidates. The most important element of the early discovery process is to select the best new molecular entities to enter clinical trials and to limit failure in full development. The priority during the preclinical selection process is the safety and efficacy testing of a new molecular entity, which is important for small chemical molecules and biotherapeutic compounds alike.

Webinars
Improving Quality of Bacterial Culture and Oligo Nucleotides with UV/Vis Spectroscopy to Accelerate mRNA Vaccine Production
Bacterial growth rate influences gene expression by acting on both sides of the mRNA equilibrium: synthesis and degradation. Discover how the Thermo Scientific GENESYS and Evolution series UV/Vis spectrophotometers can be used to evaluate and achieve optimum bacterial culture growth rate and measure oligonucleotide quality to ensure vaccines produced are not contaminated.
  Watch webinar

From preclinical samples to clinical phase supply, this stage involves pilot-scale development of the drug, addressing analytical methods, process chemistry, process development and optimization, and approaches for scaleup. Early development also encompasses the formulation process to assess the best composition and compounding method of the API and other excipients for safe, timely, and effective delivery to the therapeutic target.

Webinars
Biodegradable Long-acting Injectable Implants Prepared by Hot Melt Extrusion
InnoCore Pharmaceuticals shares their experiences on how to prepare long lasting implants using hot melt extrusion (HME), an overview and applications for injectable implants, and what to consider when choosing polymeric matrices for drug delivery systems.
   Watch webinar
Effective Imaging for Identification and Sizing API Domains
The distribution of API in a pharmaceutical tablet is a critical factor in developing drugs that are effective when consumed. The combination of FTIR and Raman spectroscopy with mapping is well-suited for identifying and sizing API domains. Both techniques provide excellent chemical and spatial information about the distribution and concentration of the API in a tablet.
  Watch webinar
Predicting the Crystalline Nature of APIs with a Novel In-line X-ray Technique: InsituX
University of Rouen Normandy discusses how the precise identification of solid phases and their crystallinity are important for the design of drying, the storage conditions, and the repeatability of the solid transformations regarding APIs, as well as the identification of non-stoichiometric solids and the possible presence of polymorphs of hydrates and anhydrates.
  Watch webinar
Improving Solubility with Hot Melt Extrusion (webinar series)
Explore this webinar series on improving the solubility of APIs with HME by creating solid dispersions. This series covers: solid dispersion: a supersaturable formulation to improve bioavailability of orally administered APIs; enabling strategies for development of HPMCAS-based amorphous solid dispersion by HME; a closer look into ASD formulations: a tale of two solid dispersions
  Watch webinars

Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs. Reliable analytical methods, on-line and off-line, are necessary to develop a robust, well documented and safe process that can be registered with regulatory bodies. Scalable manufacturing unit-operations, such as granulation and hot melt extrusion can be used to tailor production output to market demands.

Webinars
Lean Manufacturing Practices with Raman Spectroscopy for the Biopharmaceutical Production
Learn about the role of Raman spectroscopy in the rapid release of raw materials through identity testing and real-time release testing of final products such as vaccines, hormones, and monoclonal antibodies.
  Watch webinar
Advances in Twin-screw Granulation Technologies
Review the basic concept of TSG, discuss the influence of process parameters on final product quality, and provide insights into recent advances in TSG continuous manufacturing.
  Watch webinar
NIR to the Rescue: Production Efficiency and Cost Savings for Pharma
Reducing costs and improving efficiency have always been a goal, but these needs are increasingly critical for pharmaceutical companies. This webinar will highlight NIR’s incredible capabilities across a variety of drug forms, in regulatory compliance, for GMP environments, and more.
  Watch webinar
Injectable Implants: Manufacturing Advanced Medicines with Hot Melt Extrusion
Injectable implants offer several advantages as drug delivery systems including site-specific release and high patient compliance. Hot melt extrusion (HME) is an ideal method to manufacture as scalable from early R&D to commercial manufacturing and can be done in a continuous manufacturing environment. Watch this webinar for an overview of implant types, materials, and scale-up from development to full-scale manufacturing.
  Watch webinar
Capable and Compliant XRD in Pharmaceuticals
X-Ray diffraction (XRD) offers valuable analytics in pharmaceuticals quality control. Its non-destructive nature and relatively easy sample preparation benefit all users. Learn about guidelines not only for sample preparation but also different measurement strategies while complying with even the most recent regulatory requirements.
  Watch webinar
Improve Efficiency and ROI by Adopting Molecular Spectroscopy Techniques in Pharma Manufacturing
Discover the differences between FTIR, NIR and Raman spectroscopy, learn how spectroscopy is applied in quality control labs and hear how implementation of these techniques increased efficiency and minimized costs.
  Watch webinar

Compliance is much more than Title 21 of the U.S. Code of Federal Regulations (CFR). It is a function that demonstrates and documents the quality of a pharmaceutical company’s processes and products. We need to understand the FDA’s current expectations to maintain Good Manufacturing Practices (GMPs) or specific regulatory requirements such as European Commission (EU) Annex 11. Having reliable software with your instrumentation that supports you with the ever-evolving emphasis on data integrity, security, compliant storage, and documentation can make a difference in driving your business benefit.

Webinars
Quality Assurance and Data Integrity from an Auditors’ Viewpoint
In this on-demand webinar, you will hear directly from industry auditors as they discuss the current regulatory framework for good manufacturing practice (GMP), including data integrity, validation and qualification for computerized systems in regulated laboratories.
  Watch webinar
Patheon Experience: Overcoming Challenges to Ensure Data Integrity and Standardization
Learn how and why Patheon Pharma Services implemented both FTIR Spectroscopy and a Chromatography Data System in different areas of their workflow to meet data integrity needs and the importance of these to the business.
  Watch webinar
Instrument Systems take on Burden of Compliance
Hear how two different instrument platforms – FTIR and Microvolume UV-Vis – help labs assure compliance in their processes for manufacturers in pharmaceuticals and other related industries.
  Watch webinar

Techniques
 RamanFTIRNIRXRDTwin-screw ExtrusionUV-VisRheometry
Capability

Chemical compound identification

Identification of both organic and inorganic materials

Chemical compound identification

Identification of organic materials in bulk state

Chemical compound identification QA/QC and process control

Crystalline phase identification and amorphous content determination

Enhancing bioavailability and enabling continuous granulation

Quantitative measurements of reflection or transmission properties of a materialMeasure critical rheological properties of compounds and extrusions

Study crystallization behavior
Workflow stage application: 
Research & Discovery  
Development 
Clinical Study   
Manufacturing
Raman spectroscopy

Raman spectroscopy continues to gain momentum as a viable spectroscopic technique. Complementing Fourier Transform Infrared Spectroscopy (FTIR), Raman spectroscopy and microscopy find many applications in the pharmaceutical industry including drug discovery, drug development, drug manufacturing, biologics, and medical devices. 

Raman spectroscopy is a rapid and non-destructive analytical technique that requires little to no sample preparation.  Since water is a very weak Raman scatterer, Raman is well suited for analysis of aqueous samples, such as solutions, injectables, and biological materials including tissues and cells.  By leveraging the spatial specificity of microscopy and the chemical specificity of Raman spectroscopy, Raman microscopy provides molecular level chemical annotation to sample morphology. A spatial resolution of sub-micron can be routinely achieved with a confocal Raman microscope.

Current Raman applications in the pharmaceutical industry include, but are not limited to: quality control of incoming raw materials, identifying polymorphs, monitoring real-time processes, detection of counterfeit and adulterated pharmaceutical products, finished product analysis of solid dosage forms and biologics, foreign particle identification and contaminant analysis in injectables and parenteral drug products, and imaging solid dosage formulations. 

Learn more


Learn about the Thermo Scientific DXR3 SmartRaman Spectrometer, built for dedicated bulk sample analysis, multi-purpose analytical labs with sampling versatility. 

HDI-Pharmaceutical-Manufacturing-Processes-270x195

FTIR is an analytical technique used to identify organic (and in some cases inorganic) materials. This technique measures the absorption of infrared radiation by the sample material versus wavelength. The infrared absorption bands identify molecular components and structures.

FTIR is a fast and nondestructive analytical method. Associated with chemometrics, it can become a powerful tool for the pharmaceutical industry. It is suitable for analysis of solid, liquid, and biologics pharmaceutical forms. It can be implemented during pharmaceutical development, in production for process monitoring, and in quality control laboratories.

FTIR microscopy offers many unique advantages in studying pharmaceutical packaging materials and formulations because of its sensitivity and variety of measurement modes with precise control of the area to the analyzed.

Applications covered by FTIR spectroscopy/microscopy in pharmaceutical drug development, drug formulation and manufacturing are: hyphenated technique TGA-IR for analysis of decomposition of drug product, rheometry with FTIR for understanding morphology and molecular structure simultaneously during drug formulation, stage compendial identification of raw materials based on worldwide Pharmacopeia, qualitative and quantitative evaluation of formulations, pharmaceutical packaging evaluation, and determination of quantity of active ingredients in solids and liquid dosage forms.

FTIR microscopy and imaging are used to troubleshoot manufacturing problems, identify product contaminants, image solid dosage form to evaluate and quantify distribution of API and excipients, protein secondary structure elucidation in biologics formulations, and manufacturing.

Learn more

FTIR Software

With industry-leading software, the Thermo Scientific OMNIC Software suite has become an industry standard with tens of thousands of copies in use. This software powers our range of FTIR and Raman spectrometers, providing the tools needed to acquire data from simple spectra to hyperspectral images and analyze spectra from simple identification to complex multi-dimensional datasets.

Learn more

Near-infrared spectroscopy

FT-NIR spectroscopy offers many advantages which makes it very useful for small (solids and liquid dosage forms) and large molecule (biologics, biopharma) manufacturers for routine analysis in QC labs and in process control. FT-NIR can help to streamline the analysis routines in the lab and online. It is implemented with ease in contrast to time-consuming standard analysis, the NIR method produces no wastes, causes no pollution, and requires no chemical reagents or gases, making it very cost-effective.

Major Pharmacopeias have published guidelines on the use of near infrared spectroscopy for compendial identification tests, finished product testing and for implementing quality by design (QbD) principles that ensures product compliance through closer control of processes. 

Applications covered by but not limited to FT-NIR spectroscopy are: Quality control of incoming raw materials, finished product testing, and monitoring hot melt extrusion process, moisture in lyophilized drug products. PAT applications in solid dosage form include monitoring granulation, drying, quantification of solvents, and monitoring of tablet coating processes.

PAT/QbD applications of FT-NIR spectroscopy in upstream/downstream in biopharma/biologics manufacturing are fermentation monitoring, monitoring protein concentration in cell cultures, monitoring and control of PEGylated proteins, and increasing the resin utilization in continuous chromatography with effective load control.

Learn more

X-Ray Diffraction

Quickly obtain detailed phase and structural information of your crystalline materials using X-ray diffraction (XRD), a versatile and non-destructive analytical technique. XRD analysis provides high-performance results in a wide range of pharmaceutical and research applications.

 

 

Benefits include:

  • Ease of sample preparation for both reflection or transmission mode analysis.
  • Workflow analysis with automatic data processing and validation.
  • Compatible with 21 CFR part 11 requirements

Learn more

Ultraviolet-Visible and Visible Spectrophotometry

UV-Visible spectroscopy is an established analytical technique used in the pharmaceutical industry for testing in research and quality control stages of drug development. Thermo Scientific Evolution UV-Vis Spectrophotometers provide highly accurate measurements in addition to meeting all USP and EP performance characteristics and enabling 21CFR Part 11 compliance. Thermo Scientific NanoDrop UV-Vis Spectrophotometers allow for 21CFR Part 11 compliance when measuring low volume samples and samples that absorb large amounts of light.

Meet your analytical challenges with our complete line featuring our award-winning designs and user-friendly software to help you quantify, assess purity, and more. Rely on industry-tested solutions for the pharmaceutical and research communities.

Learn more

Rheometry

Obtain the most information from your material with Thermo Scientific rheometers and viscometers, designed to accurately measure and characterize the flow properties of fluids and other complex materials. Our rheometers are known for accuracy, ease of use in quality control, product development, and research applications.

Learn more

Twin-screw extrusion

In the early development of a new drug, formulation scientists face the challenge that only a small amount of expensive API is available for experiments. Maximize your research efficiency by requiring only a small amount of material to conduct experiments. Lab scale size extruders allow you to conduct numerous trials efficiently, cost effectively, all while conserving precious laboratory space. With a Thermo Scientific lab scale twin-screw extruder, you can easily upscale from 11, 16 to 24 mm due to our design.

Our pharmaceutical extruders meet a wide range of drug development applications and are ideal for developing and testing formulations with expensive API and associated excipients.

Learn more

Compare twin-screw extruders

 
 
 Pharma mini HMEPharma 11Pharma 16Pharma 24
Recommended for
  • Feasibility
  • Small-scale HME
  • Implants (ophthalmic and injectable)
  • Research and discovery
  • Laboratory scale
  • Development pilot scale
  • Production scale
  • Manufacturing
  • Production scale
Suitable for
  • Co-extrusion
  • Implant production
  • Co-extrusion
  • Sheet extrusion
  • Implant production
  • Co-extrusion
  • Sheet extrusion
  • Implant production
  • Sheet extrusion
  • High-volume HME production
Downstream options
  • Take off belt
  • Conveyor belt
  • Pelletizer
  • Conveyor belt
  • Pelletizer
  • Chill roll
  • Conveyor belt
  • Pelletizer
  • Chill roll
Twin-screw granulation

Many pharmaceutical manufacturers are moving toward continuous manufacturing because twin-screw extruders (for wet or melt granulation) can help overcome the challenges of batch processing. The Pharma 24 TSG provides consistent and controllable processing, on-demand production, and reduced clean room space. It is also suitable for process analytical technology (PAT).

  • Efficiency and reliability
  • Ability to choose your scale
  • Flexibility and cost savings

Learn more

 

Featured On-demand Webinar
External experts - Quality assurance and data integrity from an auditors’ viewpoint

External experts - Quality assurance and data integrity from an auditors’ viewpoint

Industry auditors discuss the current regulatory framework for good manufacturing practice (GMP), including data integrity, validation, and qualification for computerized systems in regulated laboratories.

Watch webinar

Service and support
Service and support

Thermo Fisher Scientific understands the importance of instrument uptime in pharmaceutical QA/QC labs. This is why we offer a broad range of service offerings to ensure timely response and repair of mission-critical instruments.

We offer comprehensive, worldwide after-sales service and support, including instrument installation, on-site technical consultancy, applications support, instrument qualification, and compliance services.

Our customers may also take advantage of our Premier offering, which includes a two-day on-site response or industry-exclusive no-charge requalification guarantee if you add OQ to a qualifying plan—imagine hassle-free help with audit-readiness for your GMP compliance.

Learn more

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