Biologics, Recombinant Protein Therapeutics, and Biosimilars

Unlocking the Potential of Biotechnology to Produce Complex Molecules

Biotechnology is an innovative tool in pharmaceutical development, using recombinant DNA and living cells to produce medicines.

Bioprocesses are opening the door to drugs too complex to be synthesized chemically.

Those biologics are complex molecules, typically larger than 1 kilodalton, such as proteins, carbohydrates, nucleic acids, cells, tissues for transplantation, or a combination of these molecule types.

Hormones, vaccines, monoclonal antibodies, recombinant therapeutic proteins, gene and cellular therapies, or insulin are commonly used biologics.

Biotechnology to produce complex molecules

METTLER TOLEDO process analytics, spectroscopy, and laboratory technologies perfectly fit your biosimilar workflow, from research and development to biologics manufacturing.

The Advantages of Therapeutic Proteins

The advantages of therapeutic proteins and other biologics are significant.

Their action is highly specific, and their function often cannot be mimicked by chemical compounds.
Due to their specific function, the risk of biologics interfering with normal biological processes and causing side effects is minimal.
The body naturally produces them, making them very well tolerated and unlikely to target an immune response.
Biologics can efficiently replace a protein or another molecule that should have been produced by a mutated or deleted gene.

What Are Biosimilars?

Biosimilars are medical products derived from an existing biopharmaceutical at the expiration of its patent.

They are developed to be clinically comparable to the reference biologic (also called the originator) and similar to the reference product in terms of safety, efficacy, quality, structural characteristics, and biological activity.

The authorization procedures, although they differ between countries, guarantee high quality and safety for authorized biosimilar molecules.

The authorization procedure of a biosimilar emphasizes comparative analytical study.

This means that the similarity of the biosimilar product with its reference product is established through a direct comparison and is not based primarily on clinical studies as for the reference products.

Process design, quality by design (QbD), and process analytical technology (PAT) are essential in therapeutic protein and biosimilar production.

PAT enables understanding the process and building the quality directly into the process design, reducing offline quality testing to a minimum.

Scientists can use over 50 analytical methods to characterize, control, measure, and compare biosimilars with their originator versions.

They develop biosimilars and demonstrate similarity with the originator using the latest analytical and biotechnological techniques, including methods that might not have been available when the reference molecule was authorized.

Routing Testing

Various equipment and methods exist to accurately test biologics following the pharmacopeia.

Mettler Toledo instruments can help you with the following routine protein therapeutics and biosimilar testing:

Process analytic sensors to monitor and control the culture/fermentation process
Enzyme kinetics and protein assay via UV-Vis spectrophotometry
Water content using Karl Fischer titration
Physical determination of pH and osmolarity
Residual solvents, moisture content using thermogravimetric methods such as moisture analyzer, TGA combined or not on a micro-GC, or a balance
Particulate profile using particle characterization spectroscopy
Spectroscopy (Fourier transform infrared (FTIR), Raman) to study protein conformational stability and comparability with the reference product
Balances and pipettes with configurable hardware and software to align with compliance requirements
Density/refractive index for concentration determination of buffers/solutions

METTLER TOLEDO Solutions For Complex Molecules Analytics

Analytical Sensors for Bioreactors

METTLER TOLEDO produces in-line analytical sensors for monitoring and controlling key analytical par...

Industrial Weighing Scales and Systems

Bench Scales, Portable Scales, Floor Scales, Counting and Mixing Scales, Terminals, Weigh Modules, L...

Automated Lab Reactors and In-Situ Analysis

Particle size analyzers, FTIR and Raman spectrometers, chemical synthesis reactors, reactor control...

Rainin Liquid Handling Solutions

Rainin offers a wide selection of liquid handling equipment, solutions and resources for laboratorie...

Analytical Balances

High-performance analytical weighing: Accurate and reliable analytical balances and micro-analytical...

Precision Balances and Scales

Our highly versatile precision balances, offer capacity up to 64 kg and readability from 1 mg, for a...

Lab pH Instruments

Electrochemistry systems provide accurate measurements of pH, conductivity, ion, ORP, and dissolved...

UV/Vis Spectrophotometry

Discover our product range for UV/Vis spectrophotometry, including trusted instruments, smart access...

Calibration, Qualification and Maintenance for Your Solutions

METTLER TOLEDO Service is your one-stop shop for all your balance service, scale service, and inspection device service needs. From installation and initial calibration to preventive maintenance and timely upgrades, we ensure your operations run smoothly and efficiently.

Achieve and maintain compliance through consistent procedures and adhere to local and global regulations and standards, such as:

ISO 17025

EURAMET

USP, GLP and GMP

NIST Handbook 44 and OIML

Measuring Instruments Directive (MID)

Ensure a perfect start and ongoing, worry-free use with immediate and long-term benefits:

Assurance that the equipment is fit for use

Cost-savings through manufacturer's qualification services

Confidence that the equipment meets process requirements

Identification of needed calibration and maintenance

Pre-plan your periodic maintenance that provides you with complete trust that your equipment achieves:

Consistent, accurate results

Safe and reliable operation

Optimal performance possible

A longer equipment lifespan, resulting in a higher ROI

Search suggestions

Biologics, Recombinant Protein Therapeutics, and Biosimilars

Unlocking the Potential of Biotechnology to Produce Complex Molecules

The Advantages of Therapeutic Proteins

What Are Biosimilars?

Routing Testing

METTLER TOLEDO Solutions For Complex Molecules Analytics

Analytical Sensors for Bioreactors

Industrial Weighing Scales and Systems

Automated Lab Reactors and In-Situ Analysis

Rainin Liquid Handling Solutions

Analytical Balances

Precision Balances and Scales

Lab pH Instruments

UV/Vis Spectrophotometry

Calibration, Qualification and Maintenance for Your Solutions

Calibration and Certificates

Achieve and maintain compliance through consistent procedures and adhere to local and global regulations and standards, such as:

Equipment Qualification

Ensure a perfect start and ongoing, worry-free use with immediate and long-term benefits:

Preventive Maintenance

Pre-plan your periodic maintenance that provides you with complete trust that your equipment achieves:

Applications and Guidelines Documentation

Life Science Toolbox for UV Vis Spectroscopy

pH Toolbox for Life Sciences

Pipetting Toolbox for Life Sciences

Bioreactor Control System - Biopharma

Biopharmaceutical Manufacturing Guide

How to Measure pH in Protein-Containing Samples

How to Measure pH in TRIS-Containing Samples

Search suggestions

Biologics, Recombinant Protein Therapeutics, and Biosimilars

Unlocking the Potential of Biotechnology to Produce Complex Molecules

The Advantages of Therapeutic Proteins

What Are Biosimilars?

Routing Testing

METTLER TOLEDO Solutions For Complex Molecules Analytics

Calibration, Qualification and Maintenance for Your Solutions

Calibration and Certificates

Achieve and maintain compliance through consistent procedures and adhere to local and global regulations and standards, such as:

Equipment Qualification

Ensure a perfect start and ongoing, worry-free use with immediate and long-term benefits:

Preventive Maintenance

Pre-plan your periodic maintenance that provides you with complete trust that your equipment achieves:

Applications and Guidelines Documentation

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