Engineering Commons^™

Antibody Production With Site-Specific Non-Natural Amino Acid Incorporation For Generation Of Antibody Drug Conjugates, Alyssa Powell

Cell Culture Engineering XV

Ambrx’s mammalian expression platform (EuCODE) enables site-specific incorporation of non-natural amino acids into antibodies. This EuCODE technology provides a means for stable payload linkages at defined sites and with a defined DAR of 2 for antibody drug conjugate (ADC) generation. While the ability to control the DAR and payload site can provide an advantage to an ADC, the incorporation of the non-natural amino acid into the antibody heavy chain introduces a unique challenge for antibody production.

To achieve high production of monoclonal antibodies (mAbs) containing non-natural amino acids, we engineered a CHO-K1 cell line which stably contains Ambrx’s patented tRNA …

Cell Therapy Manufacturing Strategies: Impact On Cost Of Goods, Cost Of Development And Commercialisation, Suzanne Farid

Cell Culture Engineering XV

Successful commercialisation of cell therapies will be underpinned by cost-effective, robust and scalable manufacturing processes, practical supply chain solutions for delivery to patients and early planning of reimbursement. UCL’s Decisional Tools team have developed advanced decision-support tools that effectively integrate concepts from bioprocess economics, risk analysis, and combinatorial optimization to address such challenges. This presentation will provide some of our most recent process economic insights from such models applied to current and future cell therapy manufacturing processes. Bottlenecks in upstream and downstream processes will be identified and the technical innovation required to bridge the gaps constraining commercialisation will be discussed. …

Challenges And Their Resolutions During Process Development And Tech Transfer Of A Late Stage Bispecific Antibody Product, Marcela Yu

Cell Culture Engineering XV

During the Phase III process development and tech transfer of a bispecific antibody project in Sanofi, many technical and logistical challenges were encountered for this cross-site collaboration project. In particular, Phase III process development and tech transfer involves three different sites as sending and receiving units located in different continents using different scales of equipment. Due to this constraint, additional considerations are required to address gaps between different small scale models prior to scale-up in order to de-risk the challenges that we may encounter during process transfer. Particularly, computational fluid dynamics (CFD) modeling and first principles calculation are used not …

Laboratory Scale Continuous Linear Purification As A Development Tool For Recombinant Blood Protein Processing, Using Chromatographic Resins And Membranes, Michael Hughson, Rimenys Carvalho, Thaynna Araujo Cruz, Leda Dos Reis Castilho

Integrated Continuous Biomanufacturing II

Continuous processing offers significant advantages for the processing of unstable recombinant products such as therapeutic plasma proteins. As such we have established a development platform to assess potential purification steps as part of a continuous linear process using a standard AKTA Explorer. Following a consistent format of IEX membrane to HIC membrane to affinity resin, we were able to rapidly investigate multiple purification pathways for a recombinant blood protein. Using membranes as the first two steps enables a 3-step purification process to be carried out in 3 to 4 hours, with a total turnaround of 5 to 6 hours including …