Sunbather

Overview

The GMP-ready LNP producer.

  • Capabilities
  • Specifications
  • Jump to GMP in a jiff
    • Transferring your LNPs to GMP can be a costly, messy process.
    • It usually means switching equipment, using a different flow path and mixer — basically a painful re‑development and re-validation of all your hard work.
    • Sunbather makes the move to GMP a walk in the park with the documentation, replaceable flow path and easy transfer built right in.
    • It uses the same mixing process and protocol as its Sunny Suite family members Sunscreen and Sunshine, so you can take your dialed in formulation into GMP without all the fuss.
    • Up to 1.8 L/h
    • Integrated in-line dilution
    • Fully replaceable flow path
    • Range of mixer types
    • 21 CFR Part 11 compliant software
    • Transferrable process from Sunshine
  • Mix it up big time-

Prep one input channel with payloads, the other with lipids and you’re ready to mix them up with a Sunny. For a simple, well-known T-mixing approach grab a Sunny T, or to increase fluid contact area for particle formation with a cross-junction, use a Sunny X. To use Sunbather’s full range of flow rates, ratios and integrated in-line dilution, choose a Sunny Trident. GMP-ready Sunnies are made with quick-change, top connection points into the flow path, keeping their microfluidic channels pristinely clean and making it easy to sub them in and out of Sunbather.

  • GMP-ready when you are-

Sunbather comes available with an installation qualification and operational qualification (IQ/OQ), and comprehensive user training so that you can get up and running as fast as possible. With fully traceable wetted materials, extractables data, and a manufacturing process grounded in by our Quality Management System (QMS), you’ll be ready to dive straight into GMP with Sunbather.

  • No-nonsense, compliant software-

Sunbather’s software serves up Administrator and Operator access levels, a 21 CFR Part 11 compliant audit trail, and password signoff for process critical actions. The software’s simple user interface means fast familiarization, and the touchscreen kiosk keeps things clean and makes setting up a new run a breeze. 

  • The Sunny Suite-

The Sunny Suite has a killer solution for every step of your LNP development. Sunscreen automates high-throughput screening of up to 96 formulations at a time to help you quickly discover your winning LNP formulations. Sunshine then takes your best formulations and hones in on the perfect mixing process conditions, with both automated experiments and continuous flow modes. When you’re ready for clinical trials, Sunbather dials up your particles in a fully GMP-compliant environment.

  • Trust the process-

Using the same pumps for fluid delivery, and same range of Sunnies for mixing up your formulations, the Sunny Suite makes the transition from formulation screening to process development to GMP production smooth sailing. Whether you’re screening through hundreds of 200 μL formulations or producing liters of particles for clinical trials, you can trust the Sunny Suite to deliver the same consistent results at any scale.

Application

Throughput10 mL/min per channel
Total flow rate range0.1–30 mL/min (configuration dependent)
Flow rate ratio (aqueous to organic) range1:1 to 10:1
Typical particle size range40–200 nm*
PDI<0.2*
Encapsulation efficiency>90%*

Instrument

Physical

Weight and dimensions (instrument only)19 kg, 29 cm H x 41 cm W x 32 cm D
Operating pressure0-10 bar

Electrical

Voltage Input100 V–240 V AC, 50-60 Hz
Power consumption (peak/average)1A/500 mA

Other information

Fluidic port sizes¼”-28 threaded nut, luer fitting (male and female)
Wetted materialsPEEK, FEP, Glass, PTFE, Silicone
ComputerWindows 11 Enterprise Touchscreen PC with Kiosk-mode operation

Consumables

GMP SunniesGMP-ready glass microfluidic mixing devices of various geometries and channel sizes
Available typesSunny 490 Trident T, Sunny 100 X, Sunny 100 T, Sunny 190 X,Sunny 190 T, Sunny 275 X, Sunny 275 T, Sunny 150 3D,Sunny 50 Micromixer
Sunbather 1-Sunny Flowpath PackA complete wetted flowpath for use with the Sunbather instrument running a 1-Sunny configuration.
Sunbather 2-Sunny Flowpath PackA complete wetted flowpath for use with the Sunbather instrument running a 2-Sunny configuration.

Overview

The GMP-ready LNP producer.

Capabilities

  • Jump to GMP in a jiff
    • Transferring your LNPs to GMP can be a costly, messy process.
    • It usually means switching equipment, using a different flow path and mixer — basically a painful re‑development and re-validation of all your hard work.
    • Sunbather makes the move to GMP a walk in the park with the documentation, replaceable flow path and easy transfer built right in.
    • It uses the same mixing process and protocol as its Sunny Suite family members Sunscreen and Sunshine, so you can take your dialed in formulation into GMP without all the fuss.
    • Up to 1.8 L/h
    • Integrated in-line dilution
    • Fully replaceable flow path
    • Range of mixer types
    • 21 CFR Part 11 compliant software
    • Transferrable process from Sunshine
  • Mix it up big time-

Prep one input channel with payloads, the other with lipids and you’re ready to mix them up with a Sunny. For a simple, well-known T-mixing approach grab a Sunny T, or to increase fluid contact area for particle formation with a cross-junction, use a Sunny X. To use Sunbather’s full range of flow rates, ratios and integrated in-line dilution, choose a Sunny Trident. GMP-ready Sunnies are made with quick-change, top connection points into the flow path, keeping their microfluidic channels pristinely clean and making it easy to sub them in and out of Sunbather.

  • GMP-ready when you are-

Sunbather comes available with an installation qualification and operational qualification (IQ/OQ), and comprehensive user training so that you can get up and running as fast as possible. With fully traceable wetted materials, extractables data, and a manufacturing process grounded in by our Quality Management System (QMS), you’ll be ready to dive straight into GMP with Sunbather.

  • No-nonsense, compliant software-

Sunbather’s software serves up Administrator and Operator access levels, a 21 CFR Part 11 compliant audit trail, and password signoff for process critical actions. The software’s simple user interface means fast familiarization, and the touchscreen kiosk keeps things clean and makes setting up a new run a breeze. 

  • The Sunny Suite-

The Sunny Suite has a killer solution for every step of your LNP development. Sunscreen automates high-throughput screening of up to 96 formulations at a time to help you quickly discover your winning LNP formulations. Sunshine then takes your best formulations and hones in on the perfect mixing process conditions, with both automated experiments and continuous flow modes. When you’re ready for clinical trials, Sunbather dials up your particles in a fully GMP-compliant environment.

  • Trust the process-

Using the same pumps for fluid delivery, and same range of Sunnies for mixing up your formulations, the Sunny Suite makes the transition from formulation screening to process development to GMP production smooth sailing. Whether you’re screening through hundreds of 200 μL formulations or producing liters of particles for clinical trials, you can trust the Sunny Suite to deliver the same consistent results at any scale.

Specifications

Application

Throughput10 mL/min per channel
Total flow rate range0.1–30 mL/min (configuration dependent)
Flow rate ratio (aqueous to organic) range1:1 to 10:1
Typical particle size range40–200 nm*
PDI<0.2*
Encapsulation efficiency>90%*

Instrument

Physical

Weight and dimensions (instrument only)19 kg, 29 cm H x 41 cm W x 32 cm D
Operating pressure0-10 bar

Electrical

Voltage Input100 V–240 V AC, 50-60 Hz
Power consumption (peak/average)1A/500 mA

Other information

Fluidic port sizes¼”-28 threaded nut, luer fitting (male and female)
Wetted materialsPEEK, FEP, Glass, PTFE, Silicone
ComputerWindows 11 Enterprise Touchscreen PC with Kiosk-mode operation

Consumables

GMP SunniesGMP-ready glass microfluidic mixing devices of various geometries and channel sizes
Available typesSunny 490 Trident T, Sunny 100 X, Sunny 100 T, Sunny 190 X,Sunny 190 T, Sunny 275 X, Sunny 275 T, Sunny 150 3D,Sunny 50 Micromixer
Sunbather 1-Sunny Flowpath PackA complete wetted flowpath for use with the Sunbather instrument running a 1-Sunny configuration.
Sunbather 2-Sunny Flowpath PackA complete wetted flowpath for use with the Sunbather instrument running a 2-Sunny configuration.

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