Pre-clinical

Pre-clinical testing establishes that the target compound demonstrates the safety and efficacy necessary to advance to human testing. At this stage, in vitro and in vivo testing can require several years and if successful, leads to the preparation and filing of an Investigational New Drug (IND) application.

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FDA Investigational New Drug (IND) Application
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Biopharmaceutical Application Guide
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Toxicology testing services are critically important. A broad spectrum of in vitro and in vivo toxicology testing is required and must be designed in accordance with international guidelines, conducted in full compliance with good laboratory practice (GLP) regulations.

Process Development Considerations

Cell line development
Clone selection
Media and feed screening
Upstream process development
Master cell bank establishment
Downstream process development
Formulation development
Analytical methods development and optimization
Analytical process development support
Biosimilars comparability analytical programs

Infographic of BioReliance® cell line development services during pre-clinical phase of new drug investigation

Cell Line Development Considerations

Clone choice – cell lines that can produce the biologic at a sufficient titer and quality
Robustness studies – studies that replicate scale-up conditions
Genetic stability – protein production and quality should remain stable after >60 generations of cells

Process Development Considerations

Process efficiency – eliminating wasteful steps and capacity utilization
Process viability – reproducibility through scale-up and tech transfer
Financial viability – balancing productivity with cost

Infographic of considerations affecting the pre-clinical phase of new drug development

Technology Considerations

Flexibility – single-use equipment enhances flexibility, templating, and rapid suite configuration, and reduces cleaning costs
Scalability – when choosing technologies at the earliest stages, such as scaling a bioreactor used for mammalian cell culture from 3 L to 200 L to 2000 L
Ease of use – solutions include pre-assembled sterile process flow paths; connectors that allow for aseptic connection, disconnection, and re-connection

Regulatory Considerations

Patient safety – clinical development milestones must assess safety and product effectiveness
Product quality and process robustness – data collection and analysis are needed to confirm
Filing strategy – knowing the countries where filing will happen should guide who inspects the manufacturing facility

Business Considerations

Speed to clinic – heavy investments are being made in research and development without returns
Process efficiency – proactively consider scale-up, not just initial speed
Filing strategy – identify the country to file in first and rapidly obtain access to the market

Access to the right resources helps you focus on discoveries with the greatest potential to help patients in need. Select your stage of the development process to learn more or follow the product and service links for resources.