We have recently been working on the preparation of bispecific antibody samples for the PCC stage, with experience in 6 bispecific antibody ADC projects so far. Most of the R&D and production team members also have experience with bispecific antibodies.

Yes, the quotation process commences upon receipt of the antibody sequence. To ensure smooth project execution, we typically require the following information:

For assays: (1) Relative binding activity method and cytological activity method (if available); (2) Theoretical extinction coefficient of the sequence.

For process: (1) If a vector is already available, please provide the vector, host cell information, and supporting experimental data; (2) Indicate any regulatory or declaration requirements, such as special considerations for host cell lines; (3) If no experimental data are available, please provide the product type and molecular sequence.

For development starting from a newly screened and sequenced antibody sequence, the quotation typically covers the following components:

Development and validation of analytical methods

Antibody process development (including cell line construction, cell bank establishment, and process optimization)

Toxicology batch production (including one 15L non-GMP batch and one 100L GMP batch)

Antibody critical factor studies and regulatory support studies