Celonic and Leukocare form biologics development collaboration
Celonic AG, a Swiss-based biologics contract development and manufacturing organisation (CDMO), and Leukocare AG, a German provider of drug product development services, have announced a collaboration aimed at supporting biopharmaceutical companies developing complex biologics.
The agreement, announced in Basel, Switzerland, and Martinsried, Germany, brings together Celonic’s expertise in cell line development, drug substance process development, intensified bioprocessing and GMP manufacturing with Leukocare’s data science-driven approach to drug product development. The two organisations will support selected client programmes involving bispecific antibodies, multispecific antibodies, fusion proteins and high-concentration formulations, while continuing to operate independently and serve their respective customer bases.
Manufacturing capability
Celonic provides cell line development, process development, process optimisation, and clinical and commercial GMP manufacturing for advanced biologics. Its CHOvolution® GS CHO-K1 platform, which uses transposase-enabled integration, is designed to support both standard monoclonal antibodies and more complex multispecific constructs. The company has also invested in intensified and perfusion bioprocessing, implementing continuous and semi-continuous upstream strategies intended to improve productivity and product quality, an approach it considers particularly relevant for bispecifics, multidomain constructs and high-concentration biologics, where fed-batch methods can present limitations.
Celonic traces its origins to a 1982 spin-off from the Max Planck Institute in Germany.
It now operates a development and innovation centre in Basel and GMP manufacturing facilities in Heidelberg, Germany, equipped for fed-batch, N-1 perfusion and full perfusion production, employing more than 500 staff across the two sites.
Formulation and data science
Leukocare’s contribution centres on molecular modelling, predictive analytics, advanced biostatistics and Design of Experiments methodology, which the company applies to formulation strategy for biologics and other therapeutic modalities. Its services span developability assessment, formulation development, analytical characterisation, stability studies, technology transfer and chemistry, manufacturing and controls (CMC) support, spanning the product lifecycle from early-stage development through to commercialisation.
Under the collaboration, the two companies intend to consider formulation strategy, molecular characteristics, manufacturability and process development in parallel, with the aim of helping clients establish develop-
ment strategies from pre-clinical stages through to commercial supply.
Samanta Cimitan, chief executive of Celonic AG, said the collaboration “highlights the decisive role of formulation in enabling complex biologics to reach the clinic,” adding that combining Celonic’s CHO-based development and manufacturing capabilities with Leukocare’s expertise would “create measurable value for clients developing complex molecules, bispecifics, and high-concentration drug products.”
Michael Scholl, chief executive of Leukocare AG, commented that as biologics become “increasingly sophisticated, formulation development must become more predictive, data-driven, and closely connected with process development,” noting that the collaboration was intended to help clients “make well-informed development decisions earlier, mitigate technical risk, and accelerate the path toward robust and manufacturable drug products.”
Leukocare specialises in data science-driven drug product development, integrating molecular modelling, predictive analytics and Quality-by-Design principles to support formulation and analytical characterisation for biotechnology and pharmaceutical clients.
Michael Scholl, chief executive of Leukocare
Samanta Cimitan, chief executive of Celonic
