In the field of biomanufacturing, the challenge of host cell protein (HCP) purification remains a critical hurdle in many biotherapeutic development programmes. Achieving low HCP levels is paramount for ensuring the safety and efficacy of biologics. This article explores a recent case where GTP Bioways successfully optimised a purification process for a customer struggling with HCP contamination.
Comprehensive bioprocess evaluation and optimisation
A biotech company approached GTP Bioways after encountering significant difficulties in reaching their HCP level target of ≤ 100 ppm (ideally ≤ 50 ppm) with their current DSP process developed at another CDMO. The recombinant protein in question had a molecular weight of 35 kDa and an isoelectric point (pI) of 6.1. Despite multiple attempts, the existing process resulted in unsatisfactory purity and failed to meet the desired HCP specifications.
Upon tech transfer of the process, our team conducted a thorough audit of the existing documentation and performed USP and DSP transfer runs. The initial purification scheme included two capture steps—anion exchange chromatography and hydrophobic interaction chromatography (HIC)—followed by a final polishing step using HIC.
During the audit and tech transfer phases, our experts identified several key steps that could be optimised to enhance process robustness, reduce HCP levels, and potentially increase the overall purification yield. The focus was primarily on the first two capture steps.
This case study exemplifies our commitment to providing tailored solutions to complex bioprocessing challenges that meet our clients’ specific needs. Our expertise in host cell protein purification enables our clients to achieve their clinical development objectives.
If you are facing similar challenges in your bioprocesses, we invite you to explore our comprehensive range of services. Contact us today to schedule a discussion with our expert team and discover how we can support your journey towards successful therapeutic development.
