At the time of talking, Aprecia Pharmaceuticals is 22 months into a 28-month U.S. Defense Advanced Research Projects Agency (DARPA) project. By now, there are just weeks left.
The EQUIP-A-Pharma contract was announced last summer – around 18 months in – and the motivation of the US government has been to promote the onshoring of pharmaceutical manufacturing. Aprecia and its ‘revolutionary 3D printing technology’ have been paired with Battelle and its ‘custom, small-scale chemical synthesis platform’ to engineer active pharmaceutical ingredients (API) in a manufacturing operation that utilises real-time quality analysis.
They were to do it in a compact footprint, with agility and mobility top of mind, to help the US tackle drug shortages by delivering a method that can ensure products are more rapidly developed and certified. Two products will then be filed with the FDA for Abbreviated New Drug Application (ANDA) approval.
At the centre of this effort is Aprecia’s newest manufacturing technology platform. It enables ‘real-time rapid release’ and uses a blockchain-like technology to track individual tablets and trace them back to the manufacturing process data. Traditionally, pharmaceutical manufacturing has relied on batch-based analytical testing, with representative samples being evaluated and the results used to make an assessment of an entire batch. Aprecia’s advanced additive manufacturing process, however, captures and analyses manufacturing data throughout production, covering aspects like process parameters, material deposition characteristics, dimensional measurements, weight verification, and spectroscopy data.
This scientific data, as the DARPA press release noted last year, is set to be used within the EQUIP-A-Pharma program to demonstrate that agile manufacturing can meet FDA drug product registration requirements, and be utilised to produce safe and effective pharmaceutical products. The partners expect the impact of this work to be far-reaching – reducing the effect of drug shortages, making supply chains more resilient, and enhancing the innovation potential – but it represents nothing that Aprecia hasn’t done already.
The company was founded in 2002, harnessing intellectual property (IP) developed at MIT to pioneer the use of 3D printing technology for pharmaceutical products like its flagship Spritam portfolio. With its proprietary ZipDose 3D printing technology, Aprecia has been able to design novel architectures and enable high doses of up to 1,000 mg while maintaining rapid disintegration. In 2015, it became the first – and still the only – company to receive FDA approval for a 3D-printed prescription drug.
So far, it has placed much of its focus on oral solid dosage forms, but there are opportunities beyond this product type and, through projects like EQUIP-A-Pharma, the prospect of contributing to ongoing onshoring efforts.
3D printing technology is core to it all. “We don’t use other conventional technologies,” Aprecia President and COO Kyle Smith tells TCT. “There might be some conventional technologies we use in the preparation step to print, but in terms of making the final dosage form, it’s all 3D printing with novel manufacturing steps.”
The 3D printing process at the heart of Aprecia’s approach is a binder jetting technology that has required ‘significant innovation to be suitable for drug product manufacturing.’ Some of that innovation remains a closely guarded secret, but over the years Aprecia has sought to develop specialised formulations, engineering equipment modifications, and establish process controls that align with current Good Manufacturing Practice (cGMP) requirements and cover powder flow characteristics, liquid deposition, drying conditions, and tablet handling.
