Solvent-free enhanced 3D printing of biologics

Background/problem

3D printing holds great potential for creating personalized medication and pharmaceutical dosage forms. However, it faces challenges when using powder bed-based technologies like Selective Laser Sintering (SLS) and Binder Jetting. These methods require powders with excellent flow characteristics to function smoothly. This is a straightforward case in single-component systems but becomes problematic in pharmaceutical applications where there are multiple components needing different compositions.
Biologics, which are therapeutic molecules derived from living organisms such as proteins, poses another layer of complexity for 3D printing, due to their susceptibility to degradation from heat, agitation, pH changes, and freezing. Traditional methods like lyophilization and spray drying, while useful, still pose risks of altering the native conformation of the proteins, leading to denatura­tion and loss of efficacy. Therefore, there is a critical need for innovative approaches that can stabilize these sensitive molecules during the manu­facturing process and extend their shelf life without compromising their therapeutic properties.

Tech overview/solution

This patent-pending technology from UT Austin presents a novel method for 3D printing biologics using selective laser sintering (SLS). The process employs a powder mixture of biologic molecules and polymers such as Pluronic or PEG, which can undergo sintering to form consolidated 3D structures without the need for solvents.
By utilizing electromagnetic radiation and thermal stimulus to selectively fuse the powder bed layer-by-layer, this approach enhances the stability of biologics by avoiding high heat and liquid-induced degradation. Excipients like polyols, surfactants, and buffering agents can also be added to further enhance protein integrity.
This technology enables the rapid prototyping and high-throughput manu­facturing of stable, dry biologic dosage forms at room temperature, offering a promising advance in the field of pharmaceutical manufacturing.

Benefits/competitive advantage

  • Promotes stability of biologics: The SLS process avoids solvents, enhancing the stability of biologics and reducing degradation risks.
  • Room temperature processing: It allows for the manufacturing of biologic dosage forms at room temperature, simplifying the process and reducing thermal degradation risks.
  • Solvent-free manufacturing: The SLS process is solvent-free, eliminating risks of chemical and physical degradation common in aqueous media.
  • Rapid prototyping and high throughput: The SLS process enables rapid prototyping and high-throughput manufacturing, offering an advantage over slower and less flexible traditional methods.
  • Customization and complexity: The SLS process allows for the formation of complex three-dimensional structures, enabling the creation of personalized medication and complex dosage forms tailored to specific therapeutic needs.

Opportunity

The technology can be expected to revolutionize biologics 3D printing by creating personalized and or mass-produced biologic dosage forms. This allows for rapid prototyping and high-throughput manufacturing of stable, dry biologic formulations, enhancing the stability of biologics by avoiding the use of solvents and high temperatures. For parties with interests in pharmaceutical 3D printing, additive manufacturing, biologics manufacturing, vaccine manufacturing.
Patent Information: