55 Clinical, Medical & Diagnostic Products Gelatin prototypes for medical devices at COMPAMED 2025


Rousselot, the leading collagen and gelatin brand from Darling Ingredients, attended COMPAMED 2025, highlighting the benefits of gelatin as a versatile biomaterial for medical devices. Visitors were able to engage directly with Rousselot experts and explore application-focused prototypes – including hemostats, dermal fillers, and microneedles – developed to accelerate formulation and reduce time to market.


Featured demonstrations included gelatin-based films and foams for hemostatic sponges or anti-adhesion applications, flowable hemostats with adjustable viscosity, bioresorption, and hemostatic efficiency, dermal fillers offering tailored rheology, injectability, and biocompatibility, and microneedle prototypes showing optimised mechanical strength, dissolution, and active ingredient delivery.


Gelatin is widely recognised for its physicochemical properties and biocompatibility, and Rousselot’s portfolio of modified and non-modified gelatins is known for high purity, consistent quality, and comprehensive regulatory documentation, helping developers reduce variability and support faster market entry. Attendees are invited to arrange meetings with Rousselot’s technical and regulatory teams to discuss standard and customised solutions for medical device development.


More information online: /ilmt.co/PL/mAYm and ilmt.co/PL/4lwk 65851pr@reply-direct.com


GMP-grade enzymes streamline clinical cell isolation


Amsbio, in collaboration with Nordmark Biochemicals, has broadened access to high-purity collagenase and neutral protease enzymes, now available in GMP-grade formats designed to meet the stringent demands of clinical tissue dissociation protocols.


These enzymes - sourced from Clostridium histolyticum - play a vital role in the isolation of viable cells from dense or complex tissue samples, a foundational step in regenerative medicine, cell therapy, and tissue engineering. The enhanced GMP-grade versions ensure researchers and clinicians alike can rely on robust, reproducible workflows that comply with evolving regulatory expectations.


Manufactured in facilities adhering to EU GMP standards and additional global quality frameworks - including the FDA’s CFR and ISO guidelines - these enzymes are backed by comprehensive quality control processes. Each lot undergoes rigorous testing to guarantee consistency, with verified virus inactivation and TSE safety certification.


Importantly, the enzymes have been incorporated into recent GMP-compliant protocols for mesenchymal stem cell isolation and production, as documented in studies such as Williams et al. (2025), further validating their suitability for clinical applications.


To support translational workflows, Amsbio offers both research-grade and GMP-grade versions of these enzymes with matching activity profiles. This allows users to develop and optimise methods with research-grade reagents, then seamlessly move to GMP products without revalidating their processes - a significant advantage in accelerating time to clinic.


For scientists advancing cellular therapies from bench to bedside, these clinically validated enzymes offer reliability, flexibility, and regulatory peace of mind. More information online: ilmt.co/PL/kkVd


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CE-marked whole slide scanner for clinical diagnostic workfl ows


Evident, a global leader in microscopy solutions, has introduced the SLIDEVIEW™ DX VS200 universal whole slide imaging scanner, now CE-marked under the EU In Vitro Diagnostic Regulation (IVDR, EU 2017/746) for use in clinical diagnostics across Europe.


The SLIDEVIEW DX VS200 delivers high-resolution, high-throughput scanning for a wide range of pathology applications. Designed for clinical workflows, it supports multiple slide types, magnifications, and imaging modes, ensuring exceptional image quality, reliability, and ease of use.


“CE marking under the EU IVDR is a significant milestone, highlighting our commitment to supporting diagnostic laboratories with compliant, high-performance imaging solutions,” said Dr Tina Manoharan, VP of Digital Pathology at Evident.


Beyond IVDR-certified functionality, the scanner also supports research applications including fluorescence, polarisation, darkfield, and phase contrast imaging. AI-guided sample detection and TruAI analysis provide precise cell detection, segmentation, and measurements, helping laboratories streamline workflows both during and after image acquisition. The system integrates seamlessly with lab and image management systems via DICOM and supports HL7 and FHIR protocols.


The SLIDEVIEW DX VS200 is available throughout the EU where IVDR compliance is required. More information online: ilmt.co/PL/23ny


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Synthetic DNA powers next-generation gene therapy trial


A clinical study in the United States has begun using a novel form of synthetic DNA as a key ingredient in the manufacture of an advanced gene therapy, highlighting a new era in precision biomanufacturing.


The DNA – produced using Touchlight’s enzymatic dbDNA™ platform – replaces traditional plasmid DNA with a cleaner, faster, and more scalable alternative. Its unique linear, closed-ended design eliminates bacterial sequences, delivering a high-purity template ideally suited for gene therapy production.


A senior scientist involved in the trial commented: “Using the dbDNA platform gave us the quality and scalability needed to move our program forward quickly. The production process was responsive and technically strong, and the DNA batches met every specification. Communication and support throughout were excellent.”


Unlike conventional plasmid-based manufacturing, dbDNA is created without cells, avoiding issues such as antibiotic resistance and sequence instability. This streamlined, cell-free approach aligns with regulatory priorities for safer, more consistent genetic materials and accelerates timelines for therapeutic development.


The use of dbDNA in this US clinical program follows GMP certification of Touchlight’s Hampton, UK, manufacturing site earlier this year. With its expanding partnerships and technology pipeline, the company is helping to redefine how DNA is made for advanced therapies — supporting scientists and biopharma innovators as they bring life-changing treatments to patients.


More information online: ilmt.co/PL/A8Yv 66044pr@reply-direct.com


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