In early biopharmaceutical development, teams often face tough choices with limited data, especially when selecting cell lines, optimizing formulations, or evaluating stability across large sample sets.
Does the below describe your position when choosing the best cell line/clone, assessing the best formulation or when analyzing large numbers of samples from a stability study?
At BioPharmaSpec we believe that the best decisions in early phase development, or wherever large numbers of sample matrices are produced as part of an investigation, are made based on the broadest understanding of the product's structure and physico-chemical properties. With the advanced technologies and data handling processes currently available, data generation and analysis of high sample numbers in short timeframes is perfectly achievable, which results in better informed early-stage decision making.
Too many products have failed in the later stages of development simply because, for example, early development decisions made were based on the cell line/clone producing the largest amount of the product (often resulting in under processed glycans being present or excessive aggregation of the product) or where formulation decisions were made on limited data sets without any consideration of how the formulation may impact the structural integrity of the product.
It is true that until relatively recently it has not been possible to provide a broad set of information across the above areas because the analytical equipment needed to provide an assessment across the required quality attributes were not available/adequate.
BioPharmaSpec has, however, developed focused methods to allow quality data to be provided across the structural attributes outlined below such that informed decisions can be made and some of the risk involved in biopharmaceutical development can be mitigated.
A combination of these techniques thus provides an assessment of all the required structural attributes in a time efficient manner:
In summary, it is now possible to obtain in-depth structural data for a product's critical quality attributes in a timely manner. This allow more informed decisions to be made regarding the best cell line/clone to use for the manufacture of your product, the best formulation for product stability and to assess general stability indicators in a time and cost effective way, thus ensuring that product development decisions are made based on data rather than intuition. BioPharmaSpec helps our clients through the critical early product development phase with significantly reduced risks.
"Early development of biopharmaceutical product candidates depends on the availability of as much product quality data as possible in order to take the best-informed decisions at every step in the development process. This applies to many different elements of product development, e.g. clone/cell line selection, fermentation process development, purification process development, formulation development, and stability evaluation. The more data points for important structural quality attributes that are available, the more qualified decisions can be made. BioPharmaSpec's new High Throughput characterization service is designed to deliver just that and should for several reasons be attractive to many companies engaged in early development of biopharmaceuticals. BioPharmaSpec has a long-standing track record for delivering high-quality characterization data and their technical capabilities surpass most small- to mid-sized biopharmaceutical companies."
— Lead investigator from a long-term client
Contact us to learn how our High-Throughput Characterization service can support your cell line selection, formulation screening, and stability studies with fast, multi-attribute structural insight.
