From 2012 the drug development process witnessed a massive shift with early-stage and small biotech and pharma companies shifting their business model to semi and full-virtual form. Such an approach nullifies the need for a top-end in-house bioanalytical laboratory, thereby reducing expensive investments and hiring research experts.
Cost-cutting efforts from large pharmaceutical companies led to the virtual biotech revolution, which directly resulted in an improvement in the establishment of bioanalytical testing services and clinical research organizations. Virtual and semi-virtual biotech is all about the efficient use of resources.
End-to-end bioanalytical services for virtual biotechs
The rising threat of antibiotic resistance means pharma and biolabs must constantly evolve and innovate biotherapeutics that are supported by stringent regulatory checks. The increasing demand for new biotherapeutics has put additional pressure on pharmaceutical companies, and as a result, there is a growing trend of outsourcing several stages of drug development to bioanalytical laboratories.
The virtual approach empowers biotechs to outsource each developmental operation to bioanalytical laboratories, which are highly efficient with all their costs. Bioanalytical laboratories support bioanalysis of large and small molecules, biomarker development, assay development and validation services, pharmacokinetic and pharmacodynamic studies, immunogenicity and cell-based assays, sample analysis, and post-marketing surveillance. Bioanalytical labs have a wide range of innovative platforms that can optimize study reproducibility, accuracy, and timely results.
The primary goal of multinational pharmaceutical companies in outsourcing bioanalysis is to generate higher revenues from outsourced solutions rather than self-financing. Self-financing needs a substantial amount of capital and time investments. Outsourcing to an already established bioanalytical laboratory ensures that no additional hiring of expensive experts is required. These bioanalytical laboratories have experts who can easily maneuver the complex requirements of sponsor companies. And outsourcing means accessing this expertise with already validated infrastructure and facilitating high-quality and reliable results.
Challenges with outsourcing bioanalytical services
Today large biopharmaceuticals are on a constant lookout for well-established outsourcing laboratories to reduce in-house investments, understand drug complexities and save time and resources. However, not all bioanalytical services are efficient in handling full-fledged bioanalytical requirements. Many companies have faced past challenges while outsourcing key technical steps in drug development. Some common challenges include unmet timelines, lack of technical and regulatory expertise, and unresponsiveness during emergencies.
For developing a successful drug product, both the sponsor and contracted bioanalytical company should be on the same page to comprehend the requirements and expectations. Moreover, the introduction of new technologies may at times pose a problem. Introducing such technology may need additional training, costs, regulatory compliance, and uncertainty with study results.
The road ahead for bioanalytical laboratories
Over the last decade, the number of virtual biotech companies has been increasing. Each drug product is different, and therefore laboratories will have a unique approach that fits all sponsor requirements. An ideal bioanalytical laboratory should fulfill all its client’s expectations. They should have a dedicated team consisting of seasoned clinical experts that can ensure timely delivery of accurate and reliable study results.
