Pre-clinical
Pre-clinical testing establishes that the target compound is safe and effective before it can be tested in humans, in preparation for filing an Investigational New Drug (IND) application. Considerations during the pre-clinical stage include:
- Detailed material properties
- Detailed in vitro safety testing
- Expand in vivo safety testing
- Process development
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
Cell Line Development Considerations
- Clone choice – lines that can produce the biologic at a high enough titer and quality are essential
- Robustness studies – best practice to perform studies that replicate the conditions of scale-up
- Genetic stability – protein production and quality should remain stable after >60 generations of cells
Process Development Considerations
- Process efficiency – eliminating wasteful steps and optimizing multi-work areas and capacity utilization
- Process viability – must reliably reproduce through scale-up and tech transfer to another operation
- Financial viability – balancing productivity with cost for overall financial viability
Technology Considerations
- Flexibility can reduce cost of goods – single-use equipment enhances flexibility, templating, and rapid suite configuration, and reduces cleaning costs
- Scalability is key – 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
- Evaluate for 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 – as a priority, clinical development milestones must assess safety and product effectiveness
- Product quality and process robustness – data collection and analysis should happen in parallel with process development
- Dialog with regulatory authorities – 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 – must proactively consider scale-up later down the line, not just speed early on
- Filing strategy – to identify the right country to file in first and obtain access to the market quickly
The right resources allow you to focus on discovering innovations that may help patients in need. Select any stage of the development process to learn more. Or follow the product and service links for supportive resources offering plug-and-play opportunities at the beginning of your startup creation.
Biotech Hub Resources Workflow
Discovery
Identifying the considerations, resources, and support you need to develop a new biologics candidate
Phase I–II
Accelerating your process development with tips, templates, and application guides
Phase III and Manufacturing
Progressing from scale-up and tech transfer to quality production for trials and commercialization
Startup Programs
Connecting with resources and grant programs that can unlock your molecule’s potential
Regulatory
Navigating one of the world’s most regulated industries starts with a trusted guide