QUALITY & ANALYTICAL SERVICES

Stability Studies

Do you want to secure the stability and integrity of your product throughout its life cycle and in accordance with current quality requirements?

We design and execute the required release testing and stability studies to assess quality, efficacy, and safety. From initial storage to periodic testing to final reporting, we adhere to set timelines, and our experts are always available to answer your questions.

IN A NUTSHELL

Stability Studies to Maximize Quality

For nearly 20 years, we have conducted stability studies for biological products to assess their quality, efficacy, and safety under various storage conditions. These studies ensure that your product remains effective and safe throughout its shelf life by testing its physical, chemical, and microbiological properties. The results help determine the appropriate packaging, storage conditions, and shelf life required to comply with current quality standards.

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OUR CAPABILITIES

What You Get

Type of Studies - A Selection

Forced degradation, stress, and pre-formulation studies (oxidation, temperature, freeze/thaw, agitation, photo stress, high/low pH)
Feasibility studies
Long-term, intermediate, and accelerated studies
Hand-fill-DP studies
Clinical in-use studies

Procedure for Stability Studies

We develop a comprehensive study plan tailored to your needs. We cover key details like storage time, temperature, reference material, specifications, container closure system, etc.
Our methods will be specifically validated for your product
We handle the storage and testing of stability samples at defined test intervals by well-trained subject matter experts (SME), provide interim reports with relevant data that has been verified by our experienced QC and QA teams throughout the process, and offer qualified support
Our testing of stability samples under various conditions facilitates the assignment of retest data and the regular requalification of product-specific standard material. We also provide a certificate of analysis (CoA)
Once the study has been completed, we compile an individualized final report with all collected data

ICH Guidelines We Follow - A Selection:

Q1A(R2), stability testing of new drug substances and products
Q1D, bracketing and matrixing designs for stability testing of new drug substances and products
Q1E, evaluation of stability data
Q5C, quality of biotechnological products: stability testing of biotechnological/biological products
Q6B, specifications: test procedures and acceptance criteria for biotechnological/biological products

Storage Conditions We Can Offer - A Selection:

-80 °C ± 10 °C
-20 °C ± 5 °C
5 °C ± 3 °C
25 °C ± 2 °C / 60 % RH
40 °C ± 2 °C / 75 % RH

All storage devices are qualified and connected to a monitoring system.

Selection of Biopharmaceutical Stability Indicating Methods

Physico-Chemical Properties
Visual inspection, color, clarity, protein content, pH, osmolality, conductivity

Identity & Potency
Antigen binding (ELISA), ADCC (bioassay)

Identity
Peptide mapping

Purity
SE-HPLC, CIEX-HPLC, RP-HPLC, HIC-HPLC, CE-SDS (reduced and non-reduced), cIEF, icIEF, DLS, nanoDSF

Microbiological Safety
Endotoxin (LAL), bioburden testing

Additional analyses performed at any time
Validated analytical methods for your product
Performance of methods according to the current pharmacopoeia (e. g. Ph.Eur. & USP)