Entries by Maren Kühr

Antibodies: Cornerstone of ADC precision and efficacy

Antibody-drug conjugates (ADCs) hinge on the antibody, not merely the payload or linker. Antibody precision defines efficacy, safety and therapeutic window. Emerging antibody formats – bispecifics, conditional designs and TCR-mimics – expand target space, demanding rigorous engineering to realise next-generation ADC potential.

From method validation to the life-cycle

Earlier guidelines such as ICH Q2(R1) and USP <1224>, <1225>, and <1226> viewed analytical method validation as a discrete activity focused primarily on chromatographic procedures. With ICH Q14, ICH Q2(R2), and USP <1220>, a life-cycle approach now ­considers variability and improves reliability, supported by tools like DoE, multivariate ­statistics, and digital technologies enabling Quality by Design and risk-based systems.

SciVario®twin: One Controller for All Your Needs

Efficiency and flexibility are key factors to stay competitive in the bioprocess field. With this aim in mind, the SciVario twin is a controller for small and bench-scale bioreactors, designed to save time and costs during process development and optimization.

CDMO: An SAP S/4HANA transformation in <10 months

In Life Sciences, SAP transformations for midsize CDMOs are nothing short of complex. But integrating a newly acquired site into an existing SAP landscape is a different matter entirely. At Tenthpin, we took a bold step by designing a new SAP S/4HANA template from the ground up to a new site for a leading CDMO; and then successfully deploying it to another newly acquired site in less than 10 months.

Unlock the Power of Structural Biology

In this interview Dr. Martin Stieler, founder and CEO of BIMOVIS, introduces his company and the importance of structural biology in biotech and pharmaceutical industries, and highlights how BIMOVIS helps unlock the full potential of biomolecular insights to advance drug development and strengthen R&D pipelines.

Evolving Antibody Innovation: New frontiers in cancer R&D

Fifty years after the invention of hybridoma technology, biologics have become a cornerstone of oncology drug discovery and development. From the first monoclonal antibody approval in 1995 to today’s complex antibody formats and cell-based therapies, biologics are reshaping cancer drug discovery. Yet, despite remarkable progress, the urgent need for novel targets that can exploit recent technological developments remains high.

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How T3 scaled faster in Basel’s biotech labs

T3 Pharmaceuticals shows how a biotech can move from first experiments to a major international deal keeping pace – and roots – in the Basel Area. The team built, tested and scaled inside Switzerland Innovation Park Basel Area’s Main Campus. Flexible private labs, certified shared facilities and an on-site expert community cut friction at every step. The result: faster iteration, smarter use of capital and a clear path from seed to global relevance — all inside Europe’s densest life sciences cluster.

Data-driven excellence: the cornerstone of clinical research

Essential areas such as study planning, interpretation, regulatory guidance, and key study design decisions remain human responsibilities, although AI increasingly supports routine tasks. X-act gets involved after the preclinical phase supporting clients in all clinical research phases from Phase I to IV and beyond. Their service ranges from initial planning to final analysis, reporting, and regulatory submission. European Biotechnology spoke with Jasmin Atarodi, Managing Director of X-act Cologne Clinical Research GmbH, about the benefits of partnering with experienced data specialists.

Celonic’s Strategic Alliance in ADCs

The Celonic Group and CARBOGEN AMCIS AG have formed a strategic alliance to offer a fully integrated Antibody Drug Conjugate (ADC) development and manufacturing platform. This partnership combines Celonic’s biologics expertise with CARBOGEN AMCIS’s payload synthesis and conjugation capabilities, creating a seamless, end-to-end solution for ADC developers.

Vienna: The centre of the European biotech world

This year, BIO-Europe, Europe’s leading partnering event for the entire biotech ecosystem, will take place in Vienna. From 3 to 5 November, the industry’s most important decision-makers will meet here to negotiate partnerships, contracts and financing, and to learn about the latest developments and trends. With over 5,700 participants from 60 countries, 2025 is set to see a record number of delegates, sponsors, exhibitors and presenting companies.