Release Testing & Stability Studies
Do you want to release your drug substance or drug product or perform additional stability studies to support your clinical development and market approval?
Whether you wish to transfer your test methods or need to develop them from scratch, we can carry out the necessary release testing and subsequent stability studies, supported by a strong scientific quality control team and an in-house Qualified Person.
Release Testing and Stability Studies to Maximize Quality
Profit from our long-term experience in traditional antibodies and new biologic formats. Our dedicated team, with in-depth analytical capabilities and regulatory expertise, provides client-focused project management for efficient and effective collaboration to deliver tailored solutions to meet your specific needs. We offer a risk-based quality control approach aimed at achieving your success. Beyond release testing, our services will help you gain in depth knowledge of degradation pathways, assess and confirm the stability of your product, and conduct additional analytical programs to facilitate your market approval.

What You Get
Broad Analytical QC Services in a Fully GMP Environment
- Comprehensive compendial methods for appearance, content, and physico-chemical properties
- HPLC-based analysis using a broad range of separation techniques (including size exclusion, cation exchange, hydrophobic interaction, reversed phase, and more)
- Relative N-glycan analysis
- CE-SDS for determination of size variants on the PA800 platform
- cIEF (PA800) and icIEF (Maurice) for determination charge variants
- ELISA and qPCR methods for process-related impurities and residuals (e. g. HCP, hDNA, Protein A resins, and Long® R3 IGF-1)
- Excipient concentration determination (e. g. Polysorbate 20/80)
- Microbial enumeration
- Bacterial endotoxins by LAL
- Potency and binding assays, including mode-of-action investigation
Stand-alone QC Services - A Selection
- Release testing in the EMA region
- Forced degradation, stress, and pre-formulation studies (oxidation, temperature, freeze/thaw, agitation, photo stress, high/low pH)
- Formulation studies
- Long-term, intermediate, and accelerated stability studies
- Feasibility 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
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)
Infographic

Our Promise To You
Broad Analytical Spectrum and Extensive Experience
- Ample experience in method development, validation, and transfer
- Wide selection of robust platform methods
- New format expertise for complex biologics
Reliable and Efficient Release Testing
- Services that are fully compliant for drug substance and product release
- End-to-end support, ranging from compendial testing to advanced analytics
- Efficient process that ensure timely results and speed up your approval timeline
Insightful and Thorough Stability Studies
- Comprehensive stability studies to assess shelf life and ensure product quality
- Stress and forced degradation studies, which reveal critical insights into product stability under various conditions
- Stability study data to facilitate your clinical development and market approval process