Melt Extrusion Deposition (MED®) 3D printing is an additive manufacturing, end-to-end technology that continuously converts powder feedstocks into softened/molten states followed by precise layer-by-layer deposition to fabricate produce objects with well-designed geometric structures. MED® technology can be used to develop products containing new chemical entities (NCE) as well as highly differentiated lifecycle management products for unmet medical and clinical needs. Versatile scalability and real-time monitoring allow production of medicines tailored to different clinical and commercial quantities.

Principle

The powdered raw materials are directly mixed and fused into a movable semi-solid, then extruded with high precision, printed layer by layer, to form pre-designed three-dimensional structure drug tablets.

Material Research

MED® process broadens the database of APIs and pharmaceutical excipients, encompassing 200+ pharmaceutical excipients and 1000+ compositions for 3D printing formulation development. The established temperature range for printing is from 25℃ to 250℃.

Formulation and Dosage Form Design

The flexibility of 3D printing to produce a wide range of structural designs can be used to achieve the desired release profile, overcome challenges in drug delivery and development.

Process Development

Based on the MED® technology, Triastek has built three pharmaceutical processes, which are named MED® process, MED&MIM process and MED&SSE process, for the development of pharmaceutical products with different needs.

Platform Development

Triastek has developed five 3D microstructure drug delivery technology platforms based on materials, formulation and dosage form designs, and processes research to meet challenges across diverse clinical application scenarios.

Regulatory Recognition

Triastek's MED® 3D Printing technology was accepted into the FDA Emerging Technology Program (ETP) in April 2020 based on the following merits:

Translation of Formulations and Processes from Early-Phase Development to Commercial Production

Pilot Supply

MED® 3DP Pharmaceuticals R&D Printer can be used for development and early-stage clinical batch production.

Commercial Supply

Triastek has constructed GMP compliant continuous 3D printing pharmaceutical production center with a maximum annual capacity of 75 million units in the initial continuous production line. This production line is dedicated to phase Ⅱ/Ⅲ clinical batch production and commercial production with flexible scalability.

3D Printing Formulation by Design (3DFbD®)

A digital formulation process that changes the traditional trial-and-error formulation development method can considerably increase the efficiency and success rate of drug product development and reduce development time and cost. Once the target PK profile is defined, it can be translated into the corresponding release profile that can then be used to design tablet structures and identify appropriate polymeric materials and excipients to fabricate the prototype.

Efficient Development

Structural design and data-based material allow an expedite formulation development, approximately 8-12 weeks to complete the proof of concept of complicate formulation development and enter the IND preparation phase.

Continuous Manufacturing

Simplified continuous fabrication process from raw materials to tablets without requiring pre- or post-production processing.

Flexible Product Supply

Modular design supports flexible adjustment of production capacity to meet the production needs of millions of rare disease drugs to hundreds of millions of blockbuster products.

Quality Control

The PAT is used to ensure quality control and consistency.

Versatile Applications

Solid dosage forms for various routes of administration, including oral, implants, dermal, etc. to provide delivery solutions for different drugs, including chemical drug and oral peptide.

Providing end-to-end technical solutions to pharmaceutical development including product design, development, manufacturing, and commercial supply.

Product Design

Programmable release control

Product Development

3DFbD® digital formulation development

Product Manufacturing

Digital and continuous manufacturing

Commercial Supply

Agile and flexible manufacturing system