Mr. Fabio Chianelli reports
PHARMATHER COLLABORATES WITH CRAFT HEALTH TO EVALUATE CRAFTMAKE GMP-READY PHARMACEUTICAL 3D PRINTING PLATFORM FOR PERSONALIZED PEPTIDES
Pharmather Holdings Ltd. has collaborated with Craft Health Pte. Ltd. to evaluate Craft Health's CraftMake good-manufacturing-practice-ready pharmaceutical 3-D printing platform for Pharmather's Personaliz3D Peptides partner ecosystem.
The collaboration will focus on developing novel peptide formulations and evaluating CraftMake as a reproducible platform for producing personalized peptide doses, combination formulations, controlled-release designs and differentiated dosage forms.
Pharmather also intends to explore a broader commercial relationship with Craft Health that could support the deployment of CraftMake with qualified Section 503A compounding pharmacies and advance Pharmather's Personaliz3D Peptides initiative.
The collaboration follows Pharmather's recently announced launch of Personaliz3D Peptides, an integrated personalized peptide initiative intended to connect physician oversight, telemedicine, qualified pharmacies, 3-D printing, artificial intelligence and proprietary formulations.
"Personaliz3D Peptides is not intended to simply repackage traditional compounding. Our objective is to build a repeatable technology and formulation platform that may give qualified health care providers greater control over dose, combination, release profile and dosage format," said Fabio Chianelli, chief executive officer of Pharmather. "Craft Health offers an integrated platform combining pharmaceutical 3-D printer, software and formulations, including CraftMake's GMP-ready design and manufacturing standards, which we believe are needed to advance personalized peptide products from concept to practical deployment. Together, we aim to provide qualified pharmacies and health care partners a more efficient and high-quality pathway to personalized peptide care."
Personalized peptide care needs better manufacturing
Patients and health care providers are increasingly seeking treatment options that can be tailored to individual dosing requirements and treatment goals.
However, much of today's peptide care market continues to rely on fixed doses, limited dosage formats and fragmented relationships among patients, prescribers, pharmacies, formulation developers and technology providers.
Pharmather believes pharmacies and health care providers should not have to independently build every element required to offer personalized peptide products.
Combining Pharmather's peptide strategy with Craft Health's 3-D printing technology
Pharmather intends to contribute its personalized medicine strategy, pharmaceutical development experience, peptide product priorities, health care relationships and planned Personaliz3D Peptides partner ecosystem.
Craft Health brings an integrated pharmaceutical 3-D printing platform consisting of the following.
CraftMake -- GMP-ready pharmaceutical 3-D printer
CraftMake uses semi-solid paste extrusion at room temperature without heat or ultraviolet light curing. This processing approach allows the parties to evaluate peptide formulations without introducing heating or UV-curing steps during printing.
CraftMake can produce different shapes, sizes and geometries, and supports single-material, multimaterial and pill-in-pill configurations that may be used for taste masking or sequential release.
Craft Health's CraftMake Production Plus is designed for GMP manufacturing, incorporating an enclosed printing environment and dual printheads capable of printing two materials concurrently, and has reported dosing accuracy of approximately plus or minus 1 per cent and repeatability greater than 99 per cent.
CraftControl -- workflow and printing software
CraftControl is designed to co-ordinate printing activities across the CraftMake platform. Its capabilities include no-code printing, audit trails, dashboard and analytic functions, co-ordination across multiple printers, and optional in-process camera monitoring.
CraftBlends -- printable formulation technology
CraftBlends consists of proprietary 3-D printable formulations developed for different release profiles, including immediate, delayed or enteric, sustained-release and orally disintegrating formulations.
"Craft Health was established to automate mass customization by integrating pharmaceutical 3-D printing hardware, software and formulations," said Dr. Wei Jiang Goh, co-founder and chief executive officer of Craft Health. "We believe there is a strong strategic fit between our technology platform and Pharmather's vision for personalized peptides. This collaboration will allow the parties to systematically evaluate peptide formulations, dosage designs and release profiles while creating a potential pathway for qualified health care and pharmacy partners to adopt personalized pharmaceutical manufacturing."
The plan: from peptide development to commercial deployment
Pharmather and Craft Health intend to evaluate BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax -- six peptides recently recommended by the U.S. Food and Drug Administration's pharmacy compounding advisory committee for inclusion on the Section 503A bulks list.
The evaluation is expected to assess priority peptides and combinations across a range of release profiles and dosage formats. Potential activities may include developing single- and combination-peptide formulations, patient-specific precision-dosing configurations, multilayer and multimaterial products, immediate-, delayed- and sustained-release designs, and unique dosage formats such as oral thin films, gummies and other potential formats.
Pharmather also intends to evaluate a broader commercial relationship with Craft Health to deploy CraftMake with qualified Section 503A compounding pharmacies and support Pharmather's Personaliz3D Peptides partner ecosystem.
By combining Pharmather's personalized peptide strategy and partner ecosystem with Craft Health's established 3-D printing hardware, software and formulation capabilities, the collaboration is expected to accelerate the development, validation and potential deployment of Personaliz3D Peptides. Rather than building the underlying manufacturing technology from the ground up, Pharmather can focus its resources on priority peptide formulations, differentiated dosage forms and adoption by qualified pharmacy and health care partners. Pharmather believes this collaboration represents an important step toward transforming Personaliz3D Peptides from a strategic vision into a practical and potentially scalable commercial platform.
About Pharmather Holdings Ltd.
Pharmather is a specialty pharmaceutical company focused on personalized medicines, specifically peptides and psychedelics.
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