Early drug development requires critical decisions under severe time and cost pressure. Data comes from multiple parallel activities and identifying possible key risks can be a challenge for companies with limited resources, a position many small biotechs find themselves in.
A focused risk identification and mitigation strategy leading to optimization of the lead development candidate is a key success factor in transitioning from discovery through development and into First-in-Human (FIH) studies, a pivotal milestone for any drug developer. Efficient use of limited resources and a structured plan to assess a drug candidate’s suitability for further development are essential focus points for the drug developer.
Lonza’s Early Development Services (EDS) has a long and strong history of more than 15 years in guiding early drug developers through this early de-risking landscape and facilitating the identification and optimization of the lead development candidate. Lonza EDS has the services and expertise to evaluate your molecule sequence and identify potential risk suggest risk mitigation strategies and remove or monitor any potential identified risks from a safety and/or manufacturability perspective. This allows the drug developer to realign resources, optimally design further development plans and understand development timelines more accurately and realistically.
Beginning with just the protein sequence, Lonza’s protein engineering and modelling experts apply our proprietary in silico tools to evaluate the candidate(s) risk of manufacturing and/or immunogenicity challenges. These rapid and cost-effective analyses are especially useful in ranking multiple candidate molecules to allow the drug developer to focus limited resources early on candidates that have the most attractive predicted safety and/or manufacturability profiles.
From here, Lonza EDS can express small amounts (mgs to low g quantities) of non-GMP protein expressed using Lonza’s GS® expression platform, which is known by regulators, large pharma partners and funders as a leading protein production platform. The expression activities not only produce material for further testing but also allow the drug developer to assess the candidate(s) performance on this clinically and commercially relevant expression platform. These activities de-risk the expression pathway to cell line development and clinical manufacturing and once again allow for optimal planning and budgeting. Another benefit is that knowing how the candidate(s) will behave on a commercially relevant platform is attractive to potential funders.
Maximising limited resources is critical, and reducing the need for bridging studies and re-work is absolutely essential. Changing manufacturing platform can result in altered product attributes that may need to be reevaluated in development models (in vivo and/or in vitro), which increases the time and cost of development. Therefore,minimising the number of changes during development or understanding the risk of changes is essential.
Human cell-based immunogenicity assays are a cornerstone of the safety risk assessment for biologics moving through preclinical development and into FIH studies. Lonza has an extensive suite of assays for evaluating potential immunogenicity risk, both innate and adaptive immune responses, and world-class expertise to help the drug developer understand the immunogenicity risk and provide a robust risk assessment, as required for IND filings.
Raymond Donninger
Early Development Services, Lonza
This article was originally published on iBIO NewsBrief. Gain a head start on your day with iBIO NewsBrief. Subscribe to receive top industry headlines delivered straight to your inbox.