Our 2024 Partners

MSS2024

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Sartorius BIA Separations

Sartorius BIA Separations develops and manufactures market-leading CIM® monolithic chromatographic columns for the purification and analysis of large biomolecules, such as viruses, plasmids, and mRNA, which are applied in cell and gene therapies.

The company’s Cornerstone® Biomanufacturing Development Services are the result of more than 20 years of hands-on experience with the most challenging biopharmaceutical products and offer a comprehensive approach of integrated process development solutions and novel technology designed to improve the robustness and yield of large biomolecules production while improving the safety of therapeutic products.

Sartorius BIA’s technology for manufacturing-scale purification is already used in the production of the first commercialized advanced therapeutics; the company also has a keen presence with novel drug candidates in the clinical pipeline.

www.biaseparations.com

Niba Labs

Niba Labs is an analytical laboratory with extensive expertise in digital PCR assay development and sample testing, focused on viral vector characterization studies to addresses the analytical needs and challenges of gene therapy products by thoroughly investigating quality attributes such as vector genome titer, genome integrity and impurities.

Niba Labs experts have addressed the issue of AAV vector genome integrity by developing an advanced dPCR multiplex approach.

The team, led by David Dobnik, PhD, pioneered the development of ddPCR analytical methods and provided insights and guidance for the optimisation of the manufacturing process for gene therapy drug for SMA, the globally approved gene therapy product developed by AveXis (now Novartis Gene Therapies).

As of recent, Niba Labs is GMP certified for digital PCR analytical testing and can seamlessly support its customers all the way through product life cycle, from early stages of assay development to assay validation and release testing.

www.niba-labs.com

COBIK

COBIK is a biotech development company located in southern Central Europe, Slovenia. Specializing in bioprocess development and optimization, we bring groundbreaking solutions to production of plasmids, minicircles, mRNA, mammalian and microbial based proteins, VLP nanoparticles and bacteriophages. Our team is dedicated to delivering custom solutions tailored to customer unique requirements, ensuring scalable and GMP transferable processes.

At COBIK, we pride ourselves on being a trusted collaborator in the rapidly evolving fields of gene therapy and vaccination. Our deep understanding of bioprocess design and regulatory aspects makes us an ideal partner for advancing projects. From the initial stages of plasmid construction and strain selection to the final steps of purification and product formulation, our comprehensive services cover all bases. We are equipped to handle the complexities of fermentation development and optimization, optimize downstream processes, and ensure the quality and stability of the final product through rigorous analytics.

We are committed to maintaining the highest standards in everything we do, aiming to not just meet but exceed the expectations of our partners and clients. Our goal is to become a recognized and respected partner in the biotech industry, known for our reliability, innovation, and commitment to quality. We are here to accelerate your projects, simplify complex bioprocesses, and contribute to the development of advanced therapies.

MSS2024 is a great chance to reconnect with many of our collaborators and clients. This will be an excellent opportunity to have in-depth conversations regarding future partnerships. We are excited about the prospects of sharing insights, exploring new ideas, and continuing to work together towards transformative solutions in biotechnology.

www.cobik.si

Mettler Toledo

METTLER TOLEDO is a leading global manufacturer of precision instruments. The Company is the world’s largest manufacturer and marketer of weighing instruments for use in laboratory, industrial and food retailing applications. The Company also holds top-three market positions in several related analytical instruments and is a leading provider of automated chemistry systems used in drug and chemical compound discovery and development. In addition, the Company is the world’s largest manufacturer and marketer of metal detection systems used in production and packaging. Additional information about METTLER TOLEDO can be found at

www.mt.com

Biomay

Biomay is an integrated GMP contract development and manufacturing organisation (CDMO) for end-to-end manufacturing of mRNA. Biomay’s services also include the supply of GMP-grade circular or linear template DNA used for in-vitro transcription of mRNA. For analytical testing of mRNA and template DNA, a comprehensive set of GMP-conform quality control methods is established. In addition, Biomay offers aseptic filling services for drug substance and drug product, at final batch volumes ranging from 100 mg until 50 gram scale. The company’s facilities and systems are inspected by the U.S. FDA. Biomay operates two independent manufacturing sites located in Vienna, Austria.

www.biomay.com

Polyplus

Polyplus, part of Sartorius, is a leading upstream solutions provider for advanced biologic and cell and gene therapy production from research to commercial scale.

An innovator in nucleic acid delivery, the legacy portfolio features process-centric transfection reagents, kits, and support services for viral and non-viral delivery. Custom plasmid vector design and plasmid and protein manufacturing was integrated into the offer in 2022 to expand the products and services portfolio to help the industry optimize process economics while meeting strict scientific and regulatory standards.

Headquartered in Europe, the Polyplus team continues to grow globally with operations in the United States and Asia. Since July 2023, Polyplus is now part of Sartorius.

www.polyplus-sartorius.com