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Pharma

Throughout the pharmaceutical development and production cycle, there are multiple demanding needs, from drug discovery to dosage form development and quality control. Our solutions support these stages by enabling the study of complex disease models, imaging cellular and drug interactions, characterizing the distribution of ingredients in dosage forms, identifying contaminants, and detecting counterfeit pharmaceuticals. 

Whether you are focused on understanding disease mechanisms, optimizing drug formulations, or ensuring product integrity, our advanced tools and technologies help you achieve your goals effectively and efficiently.

Let us assist you in overcoming challenges and managing risks while prioritizing your goals as a pharmaceutical innovator.

Talk to our Expert

Counterfeit Pharmaceuticals

Electron microscope based spectroscopy and micro- crystallographic analysis

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Comprehensive Pharmaceutical Workflow

OI Comprehensive Pharmaceutical Workflow
Discovery, Development and Scale-Up
Drug Discovery
Discovery, Development and Scale-Up
Process Development & Scale-up
Discovery, Development and Scale-Up
Pre-Clinical Trials
Discovery, Development and Scale-Up
Formulation (Drug Substance)
Manufacturing Consistency and Quality Control
Manufacturing (Drug Product)
Manufacturing Consistency and Quality Control
Quality Control & Assurance
Manufacturing Consistency and Quality Control
Failure Analysis & Counterfeit Control

High Content Screening
(Scientific Camera)
  • Able to capture real-time cellular dynamics at high resolution.
  • Facilitates high-throughput analysis by quickly processing large datasets, offering a competitive advantage in early drug discovery.
  • Enables quantification of multiple cellular markers simultaneously.

3D Disease Modeling
(Confocal Microscope)
  • Allows for the visualization of cell-to-cell interactions within 3D matrices.
  • Illuminates the architecture of cellular structures in their natural context.
  • Essential for understanding the disease microenvironment and targeting cellular pathways effectively.

Cellular and Molecular Interaction Analysis (Imaris)
  • The segmentation tools in Imaris such as Spots and Surfaces, enables delineation and visualization of individual cells, molecular structures, and their interactions in a 3D space.
  • The Machine Learning Object Classifier automates the classification of different cell types, helps understanding the drug effects on various cellular and molecular entities.

Reaction Kinetics
(NMR)

  • Provides detailed insights into the sequence of chemical transformations.
  • Direct observation of short-lived intermediates and their concentrations.
  • Facilitates understanding of potential bottlenecks or side reactions.

Reaction End Pointing
(NMR)
  • Real-time monitoring to ascertain the exact time a reaction reaches completion.
  • Reduces waste by preventing over-reaction or excessive use of reagents.

Reaction Monitoring
(Raman Microscope）

  • Vibrational spectra offer insights into evolving chemical species.
  • Crucial for tracking potential impurities or by-products.
  • Enables in-situ adjustments to optimize yields.

Pharmacology and Toxicology Studies
(Confocal Microscope)

  • Visualizes drug uptake, intracellular trafficking, and metabolism.
  • Captures cellular stress responses, helping in evaluating potential toxic effects.
  • Facilitates dose-response studies at the cellular level.

Motion Analysis and Quantitative Analysis
(Imaris)

  • Enables precise measurement of cellular and molecular parameters such as cell count, volume, and intensity, providing critical data for evaluating the therapeutic effects of drug compounds.
  • Offers tracking algorithms that allow for real-time monitoring and analysis of cell behavior over time. The track of cell movement, division, and interactions can reflect the dynamics of cellular responses regarding drug efficacy and safety.

Yield Optimization
(NMR)

  • Determines the exact concentration of drug molecules.
  • Tracks conversion rates, ensuring optimal resource allocation.
  • Reduces wastage by fine-tuning synthesis parameters.

Uniformity Assessment
(EDS)

  • Element-wise mapping to verify uniform distribution within a formulation.
  • Crucial to ensure consistent therapeutic doses and prevent hotspots.
  • Aids in adjusting mixing or dissolution parameters for homogeneity.

Solid Form Characterization
(NMR)

  • Differentiates crystalline from amorphous forms, which can influence solubility and bioavailability.
  • Detects potential polymorphic transitions that can affect drug stability.

Dosage Form Check
(Raman)

  • Validates the correct form (salt, polymorph, etc.) of the drug.
  • Ensures consistency across production batches.
  • Rapid feedback can assist in adjusting manufacturing parameters in real-time.

Process Analytical Technology
(PAT) (NMR)

  • Continuous monitoring of production lines for consistent quality.
  • Ensures consistency across production batches.
  • Detects aberrations quickly, reducing downtime and wastage.

API Concentration & Distribution
(EDS)

  • Validates elemental signatures correlating with API presence.
  • Ensures each unit (tablet, capsule) meets the therapeutic standard.

Polymorph Identification
(Raman Microscope)

  • Differentiates between distinct crystalline structures that a molecule can adopt.
  • Prevents unwanted polymorphic transitions that could affect drug performance.

Purity Analysis
(NMR)

  • Detects minor impurities or degradation products.
  • Validates the consistency of the formulation over its shelf-life.

Counterfeit Packaging Identification
(NMR)

  • Detects differences in packaging materials' molecular signatures.
  • Aids in tracing back to potential points of counterfeit introduction.

Elemental Composition Verification
(WDS/EDS)

  • Comprehensive analysis to determine the precise elemental composition.
  • Rapidly discerns genuine from counterfeit based on elemental fingerprints.

Discovery, Development and Scale-Up

High Content Screening
(Scientific Camera)
  • Able to capture real-time cellular dynamics at high resolution.
  • Facilitates high-throughput analysis by quickly processing large datasets, offering a competitive advantage in early drug discovery.
  • Enables quantification of multiple cellular markers simultaneously.

3D Disease Modeling
(Confocal Microscope)
  • Allows for the visualization of cell-to-cell interactions within 3D matrices.
  • Illuminates the architecture of cellular structures in their natural context.
  • Essential for understanding the disease microenvironment and targeting cellular pathways effectively.

Cellular and Molecular Interaction Analysis (Imaris)
  • The segmentation tools in Imaris such as Spots and Surfaces, enables delineation and visualization of individual cells, molecular structures, and their interactions in a 3D space.
  • The Machine Learning Object Classifier automates the classification of different cell types, helps understanding the drug effects on various cellular and molecular entities.

MR: X-Pulse Spectrometer

(https://nmr.oxinst.com/x-pulse)

In drug development, benchtop Nuclear Magnetic Resonance (NMR) spectrometers are used to analyze the structure of small molecule pharmaceuticals directly in the lab. These instruments provide detailed structural information without the need for liquid nitrogen or helium, which are typically required by high-field NMR instruments. This makes benchtop NMR a more convenient and cost-effective option for pharmaceutical research.

NMR Application Notes:

1. Characterization of Lansoprazole by Benchtop NMR Spectroscopy

https://nmr.oxinst.com/application-detail/characterization-of-lansoprazole-by-benchtop-nmr-spectroscopy

  1. Distinguishing Regioisomers in Pharmaceutical Products using Benchtop NMR Spectroscopy

https://nmr.oxinst.com/application-detail/distinguishing-regioisomers-in-pharmaceutical-products-using-benchtop-nmr-spectroscopy

3. NMR Spectrometry in Drug Discovery and Development

https://nmr.oxinst.com/application-detail/drug-discovery-and-development

  1. NMR in Process Optimisation and Development

https://nmr.oxinst.com/application-detail/process-optimisation

  1. Fully automated high-throughput fragment screening on X-Pulse NMR spectrometer

https://nmr.oxinst.com/application-detail/fully-automated-high-throughput-fragment-screening-on-x-pulse

Reaction Kinetics
(NMR)

  • Provides detailed insights into the sequence of chemical transformations.
  • Direct observation of short-lived intermediates and their concentrations.
  • Facilitates understanding of potential bottlenecks or side reactions.

Reaction End Pointing
(NMR)
  • Real-time monitoring to ascertain the exact time a reaction reaches completion.
  • Reduces waste by preventing over-reaction or excessive use of reagents.

Reaction Monitoring
(Raman Microscope）

  • Vibrational spectra offer insights into evolving chemical species.
  • Crucial for tracking potential impurities or by-products.
  • Enables in-situ adjustments to optimize yields.

EDS (both hardware and software)

https://nano.oxinst.com/products/sem-and-fib

Innovative delivery systems that protect and accurately deliver drugs are critical in the pharmaceutical and medical industries. Large-area Silicon Drift Detectors (SDDs) enable Energy Dispersive Spectrometry (EDS) to play a vital role in this research by providing precise elemental analysis of these delivery systems.

NanoAnalysis Application Notes (see attachments):

  • Nanoparticle drug delivery
  • Liposome for the controlled delivery of multiple drugs
  • Pharmaceutical Particle Counting, Size measurement and chemical analysis by SEM/EDX
  • Measuring in vitro cellular uptake of nanoparticles by transmission electron microscopy
  • Controlled Drug Delivery

Pharmacology and Toxicology Studies
(Confocal Microscope)

  • Visualizes drug uptake, intracellular trafficking, and metabolism.
  • Captures cellular stress responses, helping in evaluating potential toxic effects.
  • Facilitates dose-response studies at the cellular level.

Motion Analysis and Quantitative Analysis
(Imaris)

  • Enables precise measurement of cellular and molecular parameters such as cell count, volume, and intensity, providing critical data for evaluating the therapeutic effects of drug compounds.
  • Offers tracking algorithms that allow for real-time monitoring and analysis of cell behavior over time. The track of cell movement, division, and interactions can reflect the dynamics of cellular responses regarding drug efficacy and safety.

Alpha300, RISE, ParticleScout (https://raman.oxinst.com/produ..., https://raman.oxinst.com/products/correlative-microscopes/raman-sem-rise,https://raman.oxinst.com/produ... )

https://raman.oxinst.com/applications/pharmaceutics

Efficient and reliable control mechanisms are crucial in the development and production of drug delivery systems to ensure high-quality final products. Given the wide variation in composition and application of these products, analytical tools like WITec imaging systems are preferred in pharmaceutical research. These tools offer comprehensive chemical characterization and the flexibility to adapt methods to the specific specimen being investigated.

WITec Application Notes (see as in attachments):

  1. Pharmaceutics
  1. ParticleScout

Yield Optimization
(NMR)

  • Determines the exact concentration of drug molecules.
  • Tracks conversion rates, ensuring optimal resource allocation.
  • Reduces wastage by fine-tuning synthesis parameters.

Uniformity Assessment
(EDS)

  • Element-wise mapping to verify uniform distribution within a formulation.
  • Crucial to ensure consistent therapeutic doses and prevent hotspots.
  • Aids in adjusting mixing or dissolution parameters for homogeneity.

Solid Form Characterization
(NMR)

  • Differentiates crystalline from amorphous forms, which can influence solubility and bioavailability.
  • Detects potential polymorphic transitions that can affect drug stability.

Cypher AFM

Atomic Force Microscopy (AFM) overcomes many limitations of traditional methods and provides enhanced measurement capabilities for characterizing drug delivery systems. AFM can precisely determine the morphology and size distribution of nanoparticles in an aqueous environment. Additionally, it measures the nanomechanical properties of nanoparticles, aiding in optimizing their composition and formulation. The improved temporal resolution of high-speed AFM allows researchers to determine dissolution rates and degradation mechanisms of fast-dissolving nanoparticles.

AR Application Notes (attachments):

  1. AR Nanoparticle in drug delivery
  1. AR Understanding Antimicrobial Mechanisms using AFM

Manufacturing Consistency and Quality Control

MR: X-Pulse Spectrometer, MQC+ QA/QC Analyser, MQR TD NMR Research System (https://nmr.oxinst.com/x-pulse..., https://nmr.oxinst.com/mqc )

https://nmr.oxinst.com/pharma

In pharmaceutical manufacturing, benchtop Nuclear Magnetic Resonance (NMR) spectrometers are utilized for various critical applications, including raw material testing, purity assessment, reference standard qualification, and determining impurities or solvent content. The compact size and placement flexibility of benchtop NMR instruments make them ideal for scale-up and process development. They are particularly effective in Process Analytical Technology (PAT), providing real-time process feedback, from endpoint determination and kinetics studies to identifying intermediates.

In the realm of quality control, benchtop NMR addresses challenges such as testing potency, product uniformity, and moisture content for pharmaceutical products, ranging from small molecules to polymers. Recently developed time-domain NMR methods are now applied to new material classes, including biologics and arterial stent medical devices. Ensuring the authenticity and identifying counterfeit drugs are critical for maintaining quality patient care and brand integrity. Benchtop NMR offers rapid, robust quality assurance through unique pattern matching and outlier detection algorithms, which non-destructively determine in-vial product authenticity and stability. This technology provides comprehensive solutions for maintaining high standards in pharmaceutical manufacturing and quality control.

NMR Application Notes (attachments):

  1. Pharmaceutical Manufacturing: Consistency and Purity
  1. Measuring Fluoride in Toothpaste using MQC+
  1. API Testing: Dosage Form Characterisation
  1. Characterisation of Biologics and Biopharmaceuticals

Dosage Form Check
(Raman)

  • Validates the correct form (salt, polymorph, etc.) of the drug.
  • Ensures consistency across production batches.
  • Rapid feedback can assist in adjusting manufacturing parameters in real-time.

Process Analytical Technology
(PAT) (NMR)

  • Continuous monitoring of production lines for consistent quality.
  • Ensures consistency across production batches.
  • Detects aberrations quickly, reducing downtime and wastage.

EDS (both hardware and software)

Contamination during drug production can involve materials such as glass, metals, polymers, rubber, and organics. Identifying these contaminants is crucial for maintaining product quality. Energy Dispersive Spectrometry (EDS) is vital in this process.

AZtecLive quickly identifies contamination sources, like aluminum particles in metered dose inhalers, and AZtecFeature further analyzes the size and number of these contaminants. Glass contaminants, identified by AZtecLive and AZtecFeature, may require TEM for very small particles, as shown in studies like "Characterization of Glass Delamination by TEM."

Counterfeit drugs cost the industry millions and pose safety risks. EDS helps identify counterfeit products by analyzing packaging and tablet cross-sections. AZtecLive assesses vitamin distribution and tablet coating thicknesses, distinguishing brand-name from counterfeit tablets.

NA Application Notes (attachments):

  1. Quality Control
  1. Counterfeit Packaging
  1. Glass Contamination

API Concentration & Distribution
(EDS)

  • Validates elemental signatures correlating with API presence.
  • Ensures each unit (tablet, capsule) meets the therapeutic standard.

Polymorph Identification
(Raman Microscope)

  • Differentiates between distinct crystalline structures that a molecule can adopt.
  • Prevents unwanted polymorphic transitions that could affect drug performance.

Purity Analysis
(NMR)

  • Detects minor impurities or degradation products.
  • Validates the consistency of the formulation over its shelf-life.

Alpha300, RISE, ParticleScout

Confocal Raman imaging is used to analyze the distribution of components within formulations, characterize the homogeneity of pharmaceutical samples, determine the solid state of drug substances and excipients, and identify contaminants and foreign particulates. This technique provides valuable information for drug substance design, development of solid and liquid formulations, process analytics, and patent infringement and counterfeit analysis.

WITec Application Notes (attachments):

1. 3D Raman Imaging

2. ParticleScout

Counterfeit Packaging Identification
(NMR)

  • Detects differences in packaging materials' molecular signatures.
  • Aids in tracing back to potential points of counterfeit introduction.

Elemental Composition Verification
(WDS/EDS)

  • Comprehensive analysis to determine the precise elemental composition.
  • Rapidly discerns genuine from counterfeit based on elemental fingerprints.

Case Studies

RAMAN

Application

Quality Control & Assurance

Technique

Raman Microscope

The Problem

In pharmaceuticals, verifying uniform distribution of components in tablets is critical for efficacy and safety. Traditional methods are often invasive or lack the necessary detail, creating a need for a more precise, non-destructive technique.

The Analysis

Raman microscopy was utilized for its non-invasive, detailed chemical analysis of a painkiller tablet. This approach enabled the identification and distribution mapping of various components, including active ingredients and excipients, within the tablet, all through distinctive Raman spectra.

The Solution

Raman microscopy proved essential in ensuring the uniformity of ingredient distribution, a key quality indicator. This technique's insights allow for enhanced formulation and consistent production, vital for meeting regulatory standards and ensuring patient safety.

Application

Quality Control & Assurance

Technique

Raman Microscope

The Problem

In pharmaceutical emulsions, the homogeneous distribution of APIs and other components is critical. However, identifying and quantifying low-concentration components within the complex matrix can be challenging, which may affect the emulsion's performance and stability.

The Analysis

Utilizing Raman spectroscopy, a high-resolution 2D image of the emulsion was produced by analyzing over 4 million spectra. The color-coded image distinguishing the API, oil matrix, and a trace component. A 3D image was then compiled from multiple focal planes to detail the emulsion's chemical distribution.

The Solution

Raman imaging provided a comprehensive assessment of the emulsion’s chemical composition, revealing the precise distribution of all components, including the low-concentration third component. This analysis allows for the optimization of emulsion formulation for improved drug delivery and stability.

Application

Quality Control & Assurance

Technique

Raman Microscope

The Problem

Understanding distribution of components within a pharmaceutical emulsion is crucial for quality control and efficacy of the formulation. Carbon tetrachloride (CCl4), when emulsified with an alkane, water, and oil, presents a complex system where traditional analytic methods may struggle to provide clear differentiation and distribution of the constituent phases.

The Analysis

A 3D Raman scan can be executed over a volume of 25 x 25 x 20 µm³ using Raman microscopy, resolving the component distribution in three dimensions. The image stack compiled from two million Raman spectra showcased the emulsion's internal structure. The resulting image provided a detailed representation of how CCl4 is dissolved in the oil phase.

The Solution

The use of 3D Raman imaging offered a novel way to visualize the solubility dynamics of CCl4 in the oil phase of the emulsion. Raman spectroscopy can be implemented for detailed characterization in pharmaceutical emulsion development, ensuring homogeneity and consistency of the formulation.

IMARIS

Application

Motion Analysis

Technique

Imaris: 3D/4D Visualization & Analysis Software

The Problem

The inconsistent efficacy of the existing immunotherapies in treating certain cancer cases, necessitating a real-time analysis method to effectively evaluate the interactions between immune cells and tumor cells for a newly developed bi-specific antibody, TrisomAb.

The Analysis

Utilizing the Imaris to quantify neutrophil-tumor interactions by creating new Imaris spot and surface objects for neutrophils and tumor cells, respectively. This analysis yielded crucial statistics on cellular behavior and interactions, such as the number of interactions, distance to tumor, longest contact, and tumor area to evaluate the effectiveness of TrisomAb.

The Solution

This real-time analysis provided a clear understanding of immune cell-tumor cell interactions under TrisomAb influence, demonstrating its potential as an effective immunotherapy option. The insights obtained from Imaris are instrumental for refining TrisomAb and further research to improve immune cell infiltration into solid tumors in the pre-clinical trial stage.

Application

Molecular and Cellular Interaction Analysis

Technique

Imaris: 3D/4D Visualization & Analysis Software

The Problem

Glioblastoma's aggressive invasion into surrounding brain tissue has been a significant challenge, making it crucial to understand its invasion patterns for better prognosis and personalized therapeutic approaches. Imaging this invasion process to gain a detailed understanding has proven to be difficult.

The Analysis

Imaris performs an intricate analysis of tumor cell behavior and interactions within the tumor microenvironment. Utilizing the Spot module, single tumor cells can be tracked over time, revealing crucial data on cell position, speed, and persistence, alongside their interactions with surrounding structures like blood vessels.

The Solution

The insights derived from Imaris facilitated a deeper comprehension of glioblastoma invasion patterns, crucial for identifying potential molecular targets or intervention strategies.

 

 

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