Bioanalytics

Proteins & Amino Acids

• Protein iden­tity by deter­mi­na­tion of amino acid compo­si­tion (ninhy­drin posi­tive substances, Ph. Eur. 2.2.56)
• Amino acid analysis of raw mate­rials (Ninhy­drin posi­tive substances, Ph. Eur. 2.2.56)
• Capil­lary elec­trophoresis: Deter­mi­na­tion of purity, iden­tity and content of proteins, e.g. mono­clonal antibodies.
• Deter­mi­na­tion of purity and iden­tity of proteins by elec­trophoresis (Ph. Eur. 2.2.31 and 2.2.54) and Western blot
• Deter­mi­na­tion of protein concen­tra­tion (Ph. Eur. 2.5.33)
• ELISA estab­lish­ment and protein detec­tion using commer­cial ELISA tests

Nucleic acids

• Iden­tity, purity testing and quan­tifi­ca­tion of nucleic acids by conven­tional and quan­ti­ta­tive real-time PCR
• Detec­tion of residual host cell DNA (Ph. Eur. 2.6.35)
• Deter­mi­na­tion for Mycoplasma (Ph. Eur. 2.6.7 using NAT)
• Deter­mi­na­tion of viral cont­a­m­i­na­tion including Minute virus of mice (MMV / MVM) and Vesivirus
• Detec­tion of retro­viruses (reverse tran­scrip­tase activity) and Real Time Fluo­res­cent Product Enhanced RT Assay (F‑PERT)

Immune and cell analysis

• Culti­va­tion and storage of cell lines and PBMCs under stan­dard­ised conditions
• Cell analysis by flow cytom­etry (Ph. Eur. 2.7.24)
• Prepa­ra­tion and char­ac­ter­i­sa­tion of leuko­cytes (PBMCs) from human and animal blood (immune profiling)
• Detec­tion of immuno­log­i­cally rele­vant markers and cytokines using different tech­nolo­gies (immune monitoring)
• Mono­cyte acti­va­tion test (Ph. Eur. 2.6.30)
• ELISA imple­men­ta­tion, qual­i­fi­ca­tion and analysis
• Stability testing of analytes in matrices (phar­ma­co­ki­netic studies)
• Detec­tion of unin­ten­tional immuno­genicity / Anti Drug Antibodies

Func­tional bioassays

• Perfor­mance of cell effector assays (cyto­tox­i­city, apop­tosis, ADCC, CDC)
• Proliferation/​Reporter Gene Assays
• Imple­men­ta­tion and perfor­mance of in vitro potency assays in different cell lines
• Heparin activity deter­mi­na­tion (Ph. Eur. 2.7.5)