• Biologics
    • Modalities
      • Mammalian
      • Microbial
      • ADCs / Bioconjugates
      • mRNA / LNP
      • Drug Product
    • Technologies & Products
      • Expression Technologies
      • Discovery Products
      • Bioprocessing Products
    • Discovery and Preclinical
      • Early De-risking & Optimization
      • Cell Line & Strain Development
      • Process Development & Optimization
      • Analytical Development
      • Formulation Development
      • Non-GMP Manufacture
    • Clinical and Commercial
      • Process Development & Optimization
      • Formulation Optimization
      • cGMP Drug Substance Manufacture
      • cGMP Drug Product Manufacture
    Technical Support
    Regulatory Support
    View all locations
    View all Biologics offerings
    Woman and microscope

    Knowledge Center

    View all the latest resources available on site


    Visit our Knowledge Center

  • Small Molecules
    • Services
      • Drug Substance (API)
      • Particle Engineering
      • Drug Product
    • Technologies
      • Highly Potent API (HPAPI)
      • ADCs
      • Spray Dried Dispersions
      • Micronization & Jet Milling
      • Inhaled Delivery (DPI)
    • Solutions
      • Early Phase API
      • Commercial Production API
      • Bioavailability Enhancement
      • Integrated Offerings
    • Knowledge Center
      • Webinars
      • Presentations
      • Publications
      • Meet the Experts
      • View all
    View all Small Molecules offerings
    View all locations
    Clinical drug development & preformulation

    Knowledge Center

    View all the latest resources


    Visit our Knowledge Center

  • Cell & Gene
    • Services
      • Process Development
      • cGMP Manufacturing
      • Regulatory Consulting
      • Bioassay Services
      • Tissue Acquisition
    • Modalities
      • Autologous
      • Allogeneic
      • Viral Vectors
      • iPSCs
      • Exosomes
    • Technologies
      • MODA® Platform
      • Cocoon® Platform
      • Nucleofector® Technology
      • TheraPEAK® Media
      • Endotoxin and Pyrogen Testing
    • Knowledge Center
      • Peer-reviewed publications
      • Webinars
      • R&D Blog post
      • Whitepapers/Executive Summary
      • Poster
      • View all
    View all Cell & Gene offerings
    View all Bioscience Products
    View all locations
  • Capsules & Health Ingredients
    • Health Ingredients
    • Nutraceutical capsules
    • Pharmaceutical capsules
    • Capsule filling equipment
  • Contact
Biologics
Biologics
Modalities
  • Mammalian
  • Microbial
  • ADCs / Bioconjugates
  • mRNA / LNP
  • Drug Product
Technologies & Products
  • Expression Technologies
  • Discovery Products
  • Bioprocessing Products
Discovery and Preclinical
  • Early De-risking & Optimization
  • Cell Line & Strain Development
  • Process Development & Optimization
  • Analytical Development
  • Formulation Development
  • Non-GMP Manufacture
Clinical and Commercial
  • Process Development & Optimization
  • Formulation Optimization
  • cGMP Drug Substance Manufacture
  • cGMP Drug Product Manufacture
Back
Small Molecules
Small Molecules
Services
  • Drug Substance (API)
  • Particle Engineering
  • Drug Product
Technologies
  • Highly Potent API (HPAPI)
  • ADCs
  • Spray Dried Dispersions
  • Micronization & Jet Milling
  • Inhaled Delivery (DPI)
Solutions
  • Early Phase API
  • Commercial Production API
  • Bioavailability Enhancement
  • Integrated Offerings
Knowledge Center
  • Webinars
  • Presentations
  • Publications
  • Meet the Experts
  • View all
Back
Cell & Gene
Cell & Gene
Services
  • Process Development
  • cGMP Manufacturing
  • Regulatory Consulting
  • Bioassay Services
  • Tissue Acquisition
Modalities
  • Autologous
  • Allogeneic
  • Viral Vectors
  • iPSCs
  • Exosomes
Technologies
  • MODA® Platform
  • Cocoon® Platform
  • Nucleofector® Technology
  • TheraPEAK® Media
  • Endotoxin and Pyrogen Testing
Knowledge Center
  • Peer-reviewed publications
  • Webinars
  • R&D Blog post
  • Whitepapers/Executive Summary
  • Poster
  • View all
Back
Capsules & Health Ingredients
Capsules & Health Ingredients
Health Ingredients
Nutraceutical capsules
Pharmaceutical capsules
Capsule filling equipment
Back
Contact
Back
  • Home
  • Biologics
  • Mammalian Biopharmaceutical Services
  • Mammalian Analytical Development

Analytical Development

We have a proven track record as an adaptive partner for mammalian product development. We offer supreme analytical capabilities and expertise that encompass a wide range of technologies to support all stages of product and process development and fit your molecule needs.
Find out how we can help
Extensive experience with stability testing of drug substance and drug product.
Decades of experience in bioassay method development.

Benefit from access to the right analytical methods available when needed

We offer access to analytical capabilities that apply to monoclonal antibodies, bispecific antibodies and more complex structures, including new molecular formats.

We can help you with the establishment and implementation of a phase-appropriate analytical test strategy. Our validated analytical methods are available to support the release of early phase clinical material and have also been successfully used to support license applications following product-specific validation.

tech holding vial 

Our platform methods

We provide a wide range of platform methods for different applications which will be implemented where appropriate to save time and cost.

Bioanalytical testing methods

Potency is a critical quality attribute of the products we manufacture. For licensing of biopharmaceuticals, development and validation of a potency assay(s) should be included in the specifications for the drug substance and/or drug product.

We offer tailored bioassay method development, method transfer and method validation to ICH Q2 (R1) standards.

We have over 20 years' experience across a wide range of products provided by subject matter experts embedded in the Bioassay Method Development team (ELISA, cell based assay and SPR), supporting the global Lonza network.

Characterization methods

Characterization methods provide detailed biochemical and biophysical analysis of customer products to ensure they are as intended. Characterization of Reference Standards is required for IND, BLA and for commercial manufacture, as well as process changes. Our characterization team also supports cell line selection, process development and investigations.

We offer characterization analysis of both mAbs as well as non-mAbs.

Stability studies

Stability studies provide real time evidence on how the quality of a drug substance or drug product varies over time under the influence of different environmental factors. They also establish a shelf life and recommended storage conditions.

Stability testing uses a range of analytical methods for testing of product characteristics, identity, charge profile, purity, activity and safety. The data generated overtime is continuously monitored.

We have over 10 years' experience with stability testing of drug substance and drug product, providing data to support regulatory submissions. Following approval, we perform post-license stability studies to confirm stability consistency of bulk drug product, which is licensed for distribution.

Related Offering

Fabs, Fusion, Scaffold and Other Recombinant Proteins DNA-to-IND Program
We will screen more clones to find the highest titer clone. The offering is suitable for customers...
Learn more
Ibex® Design | Standard mAbs DNA-to-IND Program
Benefit from our fixed price, fastest DNA-to-IND program that minimizes risk and uncertainty from...
Learn more
Bispecific Antibodies DNA-to-IND Program
We provide an integrated drug substance/drug product DNA to IND program with reliable timelines...
Learn more
Mammalian Cell Line Development
Benefit from our flexible approach to cell line development matching your project’s priorities in...
Learn more
Mammalian Process Development
We provide access mammalian cell culture process development, optimization and validation services...
Learn more
Mammalian Drug Substance Manufacturing
Our global biopharmaceutical mammalian manufacturing network offers a range of cGMP production...
Learn more
Parenteral Drug Product Formulation Development
We offer formulation development for all biologics modalities and dosage forms. Learn more.
Learn more
Drug Product Manufacture
We offer fully integrated biologics manufacturing services from selection and qualification of the...
Learn more
Biologics Regulatory Services
Partner with our dedicated biologics regulatory team to define the optimal regulatory strategy for...
Learn more
Biologics

Related Insights

Visit Knowledge Center
Article
The Benefits of Mass Spectrometry for Expediting Biologics to Patients
A key development element for new molecular format biological products is to leverage the...
Monoclonal Antibody Molecule
Whitepaper/Executive Summary
Lonza Shapes Biotherapeutics Development Programs Around Different CMC Paths
As protein engineering and manufacturing technologies evolve, small biotech and major pharma...
Whitepaper/Executive Summary
Optimising bispecific antibody clonal cell selection with high-throughput analytics
It is possible to manufacture monoclonal antibodies using traditional methods, but the challenges...
Pipetting
Whitepaper/Executive Summary
Mitigate Immunogenicity Potential to De-risk Your Early Drug Development
Despite exciting breakthroughs in science and technology over the last couple of decades, the...
Webinar on-demand
Webinar (on-demand)
Early Developability and Analytics: Production of Multichain Biotherapeutics
In recent years the number of biotherapeutic molecules requiring more complex assemblies has greatly...
Webinar on-demand
Webinar (on-demand)
Predicting, Avoiding and Mitigating Risk When Developing Biotherapeutics
Developability issues can contribute to the high attrition rate of potential biotherapeutic...
Visit Knowledge Center

Latest news

View all Articles
4 Apr 2023
Media Advisory
Lonza and ABL Bio Collaborate in the Development and Manufacture of Bispecific Antibody Product
View article
4 Apr 2023
Media Advisory
Lonza and ABL Bio Collaborate in the Development and Manufacture of Bispecific Antibody Product
View article
29 Mar 2023
News Release
Lonza Completes Clinical and Commercial Drug Product Manufacturing Line in Visp (CH)
View article
29 Mar 2023
News Release
Lonza Completes Clinical and Commercial Drug Product Manufacturing Line in Visp (CH)
View article
16 Feb 2023
News Release
Lonza Completes Expansion of Conjugation Facility in Visp (CH)
View article
16 Feb 2023
News Release
Lonza Completes Expansion of Conjugation Facility in Visp (CH)
View article
13 Feb 2023
Media Advisory
Lonza to Expand Early Development Services Offering into North America
View article
13 Feb 2023
Media Advisory
Lonza to Expand Early Development Services Offering into North America
View article
View all Articles
Ways to Contact
  • Contact Us
  • Regulatory Support
  • Locations
  • Partnering with Us
Resources
  • Knowledge Center
  • Meet the Experts
  • Upcoming Events
Terms & Conditions
  • Terms and Conditions
  • Legal Disclaimer
  • Privacy Policy
  • California CCPA Notice
  • Transparency in Coverage
Lonza.com
  • Company Overview
  • News & Media
  • Investor Relations
  • Sustainability
  • Careers
  • Sitemap
© 2023 Lonza. All rights reserved.