CurifyLabs is a Finnish pharmaceutical and health technology company that develops CuraBlend® excipient bases, advanced 3D printing hardware and software for the production of customized medicines in pharmacies, hospitals, and veterinary practices. As CurifyLabs continues to scale its pharmaceutical operations in Europe and the United States, the company works with qualified external GMP laboratories for specialized analytical testing. Measurlabs supports CurifyLabs with routine analytical testing for batch release, stability studies, and other quality-related testing.
The collaboration began in April 2024 with osmolality testing and has since grown to cover the majority of CurifyLabs’ routine batch release testing, stability studies, and packaging validation across a broad range of raw materials and excipient bases.
Meeting strict analysis quality and reporting requirements
In the highly regulated pharmaceutical industry, raw materials must meet the precise specifications outlined in the applicable pharmacopoeial monograph. Covering properties such as substance identity, physicochemical characteristics, chemical purity, and microbiological quality, each monograph typically specifies approximately 5–15 distinct tests and assessments to be performed within the relevant quality framework, using appropriately qualified or verified analytical methods.
To take just one example, the common sweetener sorbitol requires a total of 13 assessments under the European Pharmacopoeia (Ph. Eur.), four of which are identification tests with different methods such as HPLC and thin-layer chromatography. The measured results for all 13 properties must meet the set specifications for sorbitol to be considered pharmaceutical grade.
"We use dozens of different raw materials for our excipient bases, all of which have to comply with pharmacopoeial standards. Being able to source practically all the required tests through Measurlabs makes my work considerably easier, as I do not have to coordinate testing across multiple laboratories," says Farnaz Shokraneh, Head of Quality Assurance and Quality Control at CurifyLabs.
The potential hassle of working with several laboratories is compounded in the pharmaceutical industry, as test results must be reported in exactly the same format every time. In addition to the results and the specifications they are compared against, each report must contain detailed sample information to ensure the traceability of each batch.
"Working with Measurlabs, I can be confident that we consistently get the reports in the required format, which facilitates efficient batch release for our raw materials and excipient bases," Shokraneh says.
From method verification to automated routine testing
The current streamlined workflow, where CurifyLabs’ quality team can select the required tests from a custom test catalog, send the samples to Measurlabs, and receive the results within a few weeks, took some time and effort to build. The reason can be found in the strict industry requirements on analytical method performance.
"Even with established pharmacopoeial methods, the transfer to a new lab requires analytical verification, where a set of verification experiments is performed to ensure each test produces accurate results in the new setting," explains Noora Svahn, Testing Expert at Measurlabs. “Now that the methods and efficient logistics procedures are in place, even for the occasional refrigerated samples, the established workflow makes routine testing highly streamlined,” she says.
Still, new testing needs emerge occasionally, and CurifyLabs’ Shokraneh appreciates the quick expert service provided by Measurlabs in these situations. A recent example is the extension of the testing scope to cover US Pharmacopoeia methods in addition to European ones.
"In many cases, the two pharmacopoeias have fully harmonized or very similar requirements. But since we have a large customer base in the US, we need to make sure that our products comply with all relevant specifications in cases where there are differences between the two," Shokraneh explains.
The USP methods will be listed in CurifyLabs’ custom test catalog alongside the Ph. Eur. ones, enabling Shokraneh and her colleagues to pick the required methods each time they place an order through the Measurlabs customer portal. Certificates of Analysis (CoAs) will also be provided separately for both markets, even when the tests are the same.
"This enables us to provide a full CoA to both EU and US customers, covering the complete test panel under the respective pharmacopoeia. In an industry where quality assurance is everything, this is extremely important," Shokraneh says.
Strong foundation for continued collaboration
Packaging validation is another recent area of expansion in the two companies’ collaboration. Similar to raw materials, pharmaceutical packaging must comply with strict pharmacopoeia-derived compositional standards, from the identification of each major constituent to ensuring the set limits for elemental and microbiological impurities are not exceeded.
"Measurlabs has been able to offer the required GMP-compliant tests for all the different packaging types we use, including blister packs, bottles, and their caps, which have to be evaluated separately. With such a comprehensive service range and responsive service, I’m sure the collaboration will continue for years to come," Shokraneh concludes.