Lot release testing

Each individual lot of a licensed drug product must be evaluated and approved prior to its release on the market. The regulatory authorities demand review of manufacturer's production data and results of quality control testing.

Quality control testing by a contracted laboratory, supports lot release by providing evidence of a guaranteed level of safety and quality of the released product, by a third, independent and impartial party. As an independent contracted laboratory, IBR Inc. supports lot release of biologics, vaccines and small molecules by means of a broad panel of bioanalytical services. Meeting customer production schedules is a key feature of our business.

IBR Inc. lot release services

Lot release activities at IBR Inc. are performed in alignment with applicable EU GMP requirements and predefined specifications for test procedures and acceptance criteria. These specifications are defined in accordance with relevant ICH guidelines, including ICH Q6A for chemical drug substances and drug products and ICH Q6B for biotechnological and biological products, as applicable.

Lot release activities are conducted under the regulatory responsibility and oversight of the designated Responsible Person in accordance with Swiss requirements (Fachtechnisch verantwortliche Person, FvP). The scope and regulatory suitability of lot release activities are assessed on a case-by-case basis in accordance with the product type, intended use, and applicable regulatory context. Read more about Quality Standards at IBR Inc.

GMP Certificates

Featured assays

Find a summary of assays to support lot release:

Potency assays and functional characterization of therapeutic antibodies and biologics

Cell-based assays and cell-based (MSD ECL)
Immunoassays (ELISA, Alpha Technology, Gyrolab, MSD ECL)
Ligand-binding assays (ELISA, MSD-ECL, Alpha Technology, Gyrolab)
Cell binding assays (FACS, MSD-ECL, HTRF)
Cytokine release assays (FACS, MSD-ECL)
Neutralization assays
Endocytosis and internalization assays (FACS)
Proliferation assays
Antigen-specific immune response
Apoptosis/cytotoxicity assays
Luciferase reporter gene assays
FcγR and FcRn binding assay (AlphaLISA, ELISA)
C1q binding assay (ELISA)
CDC, ADCC and ADCP

Protein analytics

Protein content/concentration (A280 UV/VIS spectrophotometry, Bradford Assay, BCA/Smith Assay UV/VIS based)
1D and 2D SDS-PAGE
Host cell protein (HCPs) determination (ELISA)
Determination of impurities (immunoassay)
Endotoxin determination: colorimetric endpoint and kinetic approaches
Host cell DNA determination by quantitative PCR (Taqman)

Physicochemical parameters

Appearance, osmolality, pH

IBR Inc. offers diverse technology and methodologic solutions to face a variety of challenges related to lot release. Contact us to select the best solution tailored to your specific needs.

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