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  • 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.

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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...
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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

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