Biological materials collected from patients provide critical sources for a host of applications that include basic research, drug discovery and validation, and even companion diagnostics.
Thus, collecting, maintaining, and tracking biological specimens stored in repositories require development of rigorous standardized operating procedures (SOPs).
Key challenges facing biobanking include carefully and precisely obtaining the tissue or tumor sample, appropriate handling and processing, and documenting the history of patient samples. CHI’s recent “Leaders in Biobanking Congress” meeting discussed these and other issues affecting the industry.
Because more than 80% of drugs fail in clinical trials, there is an urgent need for improved predictive preclinical cellular models, indicated Florian Unger, Ph.D., scientist, drug testing and proteomics, Indivumed. “The problem is that most current cellular models do not comprehensively represent patients’ tumors. There are a number of reasons why.
“The first issue is that individual tumors are very heterogeneous in their composition of cell types and within the same type of cancer. A second important consideration is the absolute need for a process that consistently and rigorously regiments the collection of specimens to minimize artifacts of sample collection, e.g., ischemia time. The access to viable tissues of high quality is the key for creating better models.
“Finally, there are a number of choices regarding the types of analyses that should be performed to molecularly characterize specimens. These include decisions about thorough mutational analysis, creation of functional proteomic and genomic profiles, etc.”
According to Helge Bastian, Ph.D., managing director and chief commercial officer, there is a trend for outsourcing the collection, processing, and annotations of biobank samples.
“Our company basically operates as an oncology contract research organization with biobanking and laboratory services. We found that companies not only need a reliable source for comparable samples that reveal the molecular realities like in the human body, but also find it more cost efficient for the sponsor if we also provide comprehensive analytical results and molecular profiles from such samples.”
Indivumed has an oncology biospecimen repository and clinical databank from more than 15,000 patients. Dr. Bastian reported, “The specimens we place in our biobank have been collected and processed under rigorous conditions and SOPs including having specially trained study nurses in the surgery room itself. Biospecimens for clinical research studies are more valuable as more clinical data and patient information are annotated. We collect more than 250 data points per patient, which are stored in our centralized, searchable databank IndivuNet.”
Tumor samples also can serve as a source for viable organoid tumor cultures. These can be used to create a human tumor model system in vitro that represents the heterogeneity of patients’ tumors for subsequent preclinical drug testing.
“Often researchers take human tissue and implant it into mice. But over time, grafted cells do not provide a complete picture of what happens in a human setting. Our original patient-specific tumor cultures (IndivuPTC) provide an in vitro model that represents the natural tumor microenvironment in humans. This model provides a much improved way to assess the effect of drugs.”
Dr. Bastian said the company’s ultimate goal is to quickly translate new scientific discoveries into the practice of medicine by supporting the development of the best possible and individualized diagnostic and therapeutic solutions, especially targeted at cancer.
“The way to do this is at the very beginning by looking at the tumors of individuals to get a true and detailed molecular picture of a patient’s cancer as well as by applying the most sensitive and cutting-edge technologies when analyzing the samples.”