BioReliance® End-to-End Solutions - Your CDMO Partner
CDMO

BioReliance® End-to-End Solutions
An Adaptive CDMO for Small Biotechs

We know that no two drug development processes are the same and your needs can change in an instant or gradually over time.

That's why we offer adaptable CDMO solutions for small biotechs and start-ups needing to develop and commercialize biologics. We do this by balancing speed, risk and cost through custom solutions, by leveraging our bioprocessing technologies and process development expertise, and by allowing our clients to transfer their process and knowledge to their end point at any step of their drug development. So rest assured that with more than 30 years' experience, more than 250 biomolecules and numerous GMP clinical Drug Substance batches, we can build strong working relationships around you.

Explore Some Important Considerations

Business Considerations

When designing a strategy just for you, the following business considerations are essential:

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

Cell line Development

When designing a strategy just for you, the following cell line considerations are essential:

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

When designing a strategy just for you, the following process development considerations are essential:

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

When designing a strategy just for you, the following technology considerations are essential:

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, e.g. 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

When designing a strategy just for you, the following regulatory considerations are essential:

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



What do you need at this stage of your biologic's journey to market?

Speed in taking the next step to clinic » Expertise to plan for the long term »


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