Biologics formulation & developability
Biologics like monoclonal antibodies, and gene therapy vectors like adeno-associated viruses and lipid nanoparticles, need to be carefully formulated to remain stable and effective. The perfect mix of pH, salt, buffer and other excipients is key to dialing in the perfect formulation for these complex molecules. Getting the biologics formulation wrong can lead to premature degradation or aggregation, which can reduce efficacy or lead to an unwanted immune response.
Formulation development is a slog, not because it’s particularly hard, but because there’s a lot to do. It requires creating the formulation, exchanging the drug into the formulation, and then waiting to see if it’s going to aggregate, decompose, get cloudy, or if particles will form. Formulation scientists check dozens of conditions and may ultimately make up hundreds of samples for both accelerated and long-term stability studies.
The right tool for the job
Visual Inspection Station
The Visual Inspection Station (VIS) is a triple threat. With one device you can do a quick particle count to detect particle formation, check color to determine if the formulation is changing on you, and check turbidity to see if the solution is getting cloudier. Automating this previously manual task means you have a camera that is not as subjective as a human being checking it, and the VIS can produce quantitative data and store all the images so they can be retrieved later. Best of all, the tests are non-destructive — even for color and turbidity. You can take the same vials you checked out, return them to storage, and assay the same vial a month later. The end result is you need fewer vials (and less sample) to conduct these long term biologics formulation studies.
Junior automates all your back-and-forth, over and over again, hands-on work. Explore more reaction and formulation conditions, prep samples, or hand off any other tasks you think would be better performed if you’re not the one doing it.
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Every lab has different bottlenecks and challenges. We’re all about partnering with you to build the bespoke solution that lets you do science faster and better. Have questions or can’t wait to speak with our expert team to find out what might be possible?