Biologics formulation & developability
The problem
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
Big Kahuna and Junior are automation platforms that can take on a big chunk of the process required to identify the best biologics formulation. They pull together critical steps like preparing formulations, getting your drug into those formulations, and generating analytical data for particle identification, color and turbidity, sample pH and viscosity.
What’s possible
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.
4-channel pH
The measurement of pH and changes to sample pH are crucial to understanding if your formulation is exactly what you want it to be. Measuring pH samples one by one is a drag. The 4-channel pH arm uses glass probes which are the most accurate for biologics. You can make four measurements simultaneously and can get through a 96-well plate in about an hour. If you’re measuring pH in something besides a 96-well plate, the arm can handle that with a single extendable pH probe. Big Kahuna and Junior track the calibration so you can use the same calibration throughout the day or make a new one, and it will archive the calibration data for you to check up on later.
Viscosity
Knowing a biologic’s viscosity in each formulation is key to manufacturing and understanding if it will be injectable. The viscosity station gives you a way to measure viscosity when you’re early in your biologics formulation process. It’s about 6 minutes per sample, including washing the capillary between measurements, and uses just 100 µL of sample. Big Kahuna or Junior can plow through a plate of formulations in just a day.
Junior
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.
Big Kahuna
Big Kahuna gives you automated, high-throughput, end-to-end solutions for biologics, gene therapy vectors, small molecules, polymers and catalysts. It’s completely configurable and helps you save money and time while getting more work done.
Want more info?
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?