Antibody Manufacture

At Angel Biotechnology we have a comprehensive range of services for medium-scale antibody manufacture.  This includes the production of recombinant cell lines through to pre-GMP and GMP manufacture using Wave Biotech disposable systems or traditional stirred tank bioreactors.

In our cell culture development laboratories, we have the expertise to create recombinant cell lines for therapeutic antibody expression using a range of mammalian cell type/expression vector combinations (subject to obtaining relevant licenses).  If desired we can genetically modify the antibodies to moderate their effector functions or reduce their immunogenicity, or to make them better-suited to down-stream conjugation steps.

During cell line development, cell clones are screened at an early stage for growth, productivity and stability in a range of "off the shelf" serum-free media.  The final stage of media optimization work is performed in partnership with commercial media manufacturers.  Our aim is to produce optimal cell line/medium combinations to improve antibody yields and shorten manufacturing time-lines.  The whole process of cell line construction is performed to appropriate standards, following EMEA guidance, to facilitate subsequent regulatory submission.

When a suitable cell line/medium combination has been developed, we have the option of scaling up the manufacturing process to 10L or 100L culture volumes using Wave Bioreactors (a disposable system), or to 25L using a stirred-tank bioreactor, in our GMP facility at Pentlands Science Park.  The resulting antibody can be purified in our down-stream processing suites, and if desired, antibody fragments or conjugates (non-radioactive) can be produced.