Biologics, or biopharmaceutical products, are transforming the field of medicine. These drugs hold promise for addressing a vast array of unsolved health problems, and the development of new products is a rapidly growing market full of potential. But biologics discovery can be a complex and costly process, so it’s essential to anticipate challenges and seek solutions before getting started.
What is Biologics Discovery?
Biologics discovery refers to the design or identification of pharmaceutical drug products that contain biological components, are produced within or obtained from biological sources, or both. They include everything from antibodies, hormones, gene therapies, and stem cells to semi-synthetic tissues and organs.
Compared to small molecule drugs, which are synthetic chemicals with a known structure, biologics are larger, more complex, and less stable. They tend to be more sensitive to changing environmental conditions. For these reasons, biologics discovery requires highly controlled conditions, sophisticated technology, and specialized expertise.
On the upside, biologics are more target-specific than small molecule drugs, so they can be tailored to activate or inhibit a particular endpoint with fewer potential side effects. They also unlock the potential to treat urgent and unmet medical challenges, including rare cancers and emerging infectious diseases.
What Are the Challenges in Biologics Drug Discovery?
Optimizing biologics discovery requires a firm grasp of the scientific, safety, and regulatory components of the process. Some of the most significant challenges include workflow complexity, high costs, and safety issues.
Workflow Complexity
Biologics discovery workflows require many steps, including choosing targets, selecting and optimizing candidates, identifying biomarkers, conducting preclinical tests and stability studies, and more.
Throughout the workflow, biologic products must be maintained in tightly controlled conditions. Because they are derived from organic tissue, they tend to be vulnerable to changes in temperature, light, pH, oxygen levels, and other environmental conditions. For example, biologics are often stored at freezing temperatures, and thawing must be done methodically to avoid damaging the product.
The delicate nature of biologics makes them susceptible to degradation or shearing during filtration, which is often required to ensure sterilization.
Analyzing biologics data is also more complicated than analysis of small molecule drugs, due to the complexity of the chemicals involved, such as large proteins. Standard assays and analytical methods may not be sufficient.
These factors, along with frequent regulatory changes around pharmaceutical development and manufacturing, make advance planning crucial in order to limit the risks inherent to biologics discovery.
High Research Costs
While small molecule drugs are relatively stable and can be formulated as pills and capsules, biologics typically need to be delivered as injections. That requires companies to invest in specialized bioreactors, vial-filling and syringe packaging capabilities, and other sophisticated equipment—all at an added cost.
The additional costs associated with sharing and managing vast quantities of data across or between organizations and implementing quality control mechanisms can also be significant.
Because of the tightly controlled conditions, advanced technology, and scientific expertise required to produce biologics, scaling up a drug development operation (while maintaining equivalence between batches) can also be costly.
Research indicates that nearly 70% of spending on drug development is due to failures at various stages of the process, underscoring the importance of anticipating and eliminating potential sources of error from the get-go.
Safety Issues
Materials used in biologics are produced in conditions that are favorable to viruses and bacteria, creating the potential for infection.
At all stages of drug development, including the preclinical phase, extensive testing is needed to detect and rule out potentially harmful side effects, such as immunotoxicity.
Product contamination is an inherent risk in the development of biologics, especially if biological material is not properly sourced. Contamination can lead to increased costs, create public health risks, or derail an entire product development cycle.
Overcoming Challenges in Biologics Discovery
Despite the challenges inherent to the process, biologics discovery remains a promising enterprise with the potential to eliminate diseases and bolster human health. There are plenty of ways to mitigate risk within the lab, including improvements to productivity, collaboration, and quality control systems.
Increasing Productivity
Labs can increase productivity and reduce the length of drug development cycles by streamlining their biologics workflows. One of the best ways to maximize productivity is to integrate every step of the biologics discovery process—from development and initial testing through quality control and validation—into a single platform.
Biologics research generates vast quantities of data. An effective strategy for managing, analyzing, and visualizing relevant data (through an ELN or analytic tool suite) can improve overall lab efficiency.
Centralizing other lab functions, such as search, reporting, and registration, can also cut down on errors and reduce wasted human capital.
Optimizing Collaboration
The high levels of complexity involved in biologics research mean that it typically involves numerous scientists and decision makers. Eliminating inefficiencies in communication and collaboration can save valuable time and ultimately expedite the process of drug discovery.
Cloud-hosted data, web-based interfaces, and shared workspaces can facilitate joint decision making and real-time analysis of experimental data.
Refining Quality Control
At the heart of every scalable, safe, and effective drug development pipeline is a rigorous quality control (QC) system. Some of the components of QC include handling biosafety, impurity, and potency issues for biologic products; setting product specifications and expiration dates; and rigorously vetting products, including supply chain validation.
Labs should establish best practices for labeling, pathogen containment, documentation of batches, and other activities in alignment with industry standards and regulatory requirements.
Learn more about Dotmatics
Read more about the unified Dotmatics platform or request a demo to learn how Dotmatics can address challenges in the lab and simplify the process of biologics discovery.