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Development of Analytical Methods01:21

Development of Analytical Methods

2.2K
An analytical methodology can be divided into four sequential steps: technique, method, procedure, and protocol. A technique is a scientific principle that rationalizes a specific phenomenon through chemical measurements. Adapting a technique for analyzing a sample of interest is termed a method. The procedure outlines the directions for performing the analysis via an analytical method. The protocol is the detailed guidelines on the procedure, which should be strictly followed to obtain the...
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Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

251
Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
251
Inertial Frames of Reference01:03

Inertial Frames of Reference

8.7K
Newton’s first law is usually considered to be a statement about reference frames. It provides a method for identifying a special type of reference frame: the inertial reference frame. In principle, we can make the net force on a body zero. If its velocity relative to a given frame is constant, then that frame is said to be inertial. So, by definition, an inertial reference frame is a reference frame where Newton's first law holds valid. Newton's first law applies to objects with...
8.7K
Non-inertial Frames of Reference01:27

Non-inertial Frames of Reference

7.1K
A reference frame accelerating or decelerating relative to an inertial frame is a non-inertial frame. To help understand this, consider what taking off in an airplane, turning a corner in a car, riding a merry-go-round, and the circular motion of a tropical cyclone all have in common. All these systems are accelerating, decelerating, or rotating relative to the Earth; hence, they all are non-inertial frames. All these systems exhibit inertial forces, which merely seem to arise from motion,...
7.1K
Chemical Shift: Internal References and Solvent Effects01:17

Chemical Shift: Internal References and Solvent Effects

1.3K
In an NMR sample, precise measurement of the absolute absorption frequencies of nuclei is difficult. A standard internal reference compound is added, and the frequency difference between the reference signal and sample signals is measured.
The internal reference compound generally used in NMR spectroscopy is tetramethylsilane (TMS). TMS is preferred because it is chemically inert, soluble in NMR solvents, and easily removable. Also, the highly shielded methyl protons in TMS yield an intense...
1.3K
Analyte Adsorption and Distribution01:09

Analyte Adsorption and Distribution

2.8K
In certain chromatographic separations, solutes transfer between the mobile phase and the stationary phase via sorption, which typically refers to the process of adsorption. For many chromatographic systems, the sorption process often depends on the polarity of the compounds—an expression of the overall dipole moment within the molecule. During the separation process, there is competition between the solute and solvent for adsorption to the stationary phase. Highly polar compounds and...
2.8K

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Related Experiment Video

Updated: Jan 28, 2026

Evaluating Usability Aspects of a Mixed Reality Solution for Immersive Analytics in Industry 4.0 Scenarios
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Usability of NISTmAb reference material for biosimilar analytical development.

Neh Nupur1, Anurag S Rathore2

  • 1Department of Chemical Engineering, IIT Delhi, Hauz Khas, New Delhi, 110016, India.

Analytical and Bioanalytical Chemistry
|March 13, 2019
PubMed
Summary

The National Institute of Standards and Technology monoclonal antibody (NISTmAb) aids biosimilar analytical method development but cannot replace innovator products for final similarity assessments. It serves as a useful class-specific external control.

Keywords:
Analytical similarityBiosimilarsClass-specificMonoclonal antibodyNISTmAbReference material

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Area of Science:

  • Biopharmaceutical Analysis
  • Analytical Chemistry
  • Regulatory Science

Background:

  • The increasing number of approved biosimilars necessitates robust analytical methods for demonstrating similarity to innovator products.
  • Establishing analytical similarity is crucial for reducing clinical trial scope in biosimilar development.
  • High cost and limited availability of innovator products create a need for suitable reference materials in biosimilar development.

Purpose of the Study:

  • To evaluate the lifecycle appropriate implementation of the NIST monoclonal antibody (NISTmAb) as a class-specific reference material in biosimilar analytical development.
  • To assess the utility of NISTmAb in supporting analytical method development and commercialization of monoclonal antibody-based biotherapeutics.

Main Methods:

  • Evaluation of NISTmAb for its application in developing initial platform analytical methods for biosimilars.
  • Assessment of NISTmAb as an external control for class-specific monoclonal antibody products.
  • Comparison of NISTmAb's performance against innovator and in-house product-specific reference materials for analytical similarity assessment.

Main Results:

  • NISTmAb is effective for developing initial platform analytical methods and can serve as an external control for class-specific products.
  • NISTmAb does not replace the need for innovator or in-house product-specific reference materials for definitive analytical similarity assessment.
  • Product-specific optimization remains a prerequisite for specific analytical properties according to regulatory guidelines.

Conclusions:

  • NISTmAb is a valuable tool for early-stage analytical method development and quality control in biosimilar research.
  • While beneficial, NISTmAb's role is complementary, not substitutive, to innovator or product-specific reference standards for final biosimilarity.
  • Adherence to regulatory guidelines mandating product-specific optimization is essential for biosimilar analytical characterization.