Ofichem is set to establish its first operational presence in the US drug substance market through an agreement to acquire New York-based CDMO Kinentia Biosciences. The Dutch pharmaceutical services company said 5 October that it has signed an agreement to acquire Kinentia, which is based in Rensselaer, New York. The transaction remains subject to approval from the Committee on Foreign Investment in the United States (CFIUS) and other customary closing conditions.

The deal will give Ofichem a US platform for drug substance development and manufacturing, while adding Kinentia’s early-stage development capabilities to the group’s existing European operations. Following completion, Kinentia’s customers will be able to access Ofichem’s broader drug substance network as programmes advance. This includes process scale-up, regulatory support and GMP manufacturing at Ofichem’s FDA-inspected facility in Ter Apel, the Netherlands.

The acquisition is intended to create a more integrated development pathway spanning the US and Europe. Ofichem says the combined business will give customers greater choice over where development and manufacturing work is performed, as pharmaceutical companies increasingly consider supply-chain resilience and regional manufacturing strategies.

The drug substance business will operate from three locations following completion: Rensselaer in New York, Ter Apel in the Netherlands and Uppsala in Sweden. Ofichem said the sites will retain different areas of expertise, allowing customers to use capabilities appropriate to the stage and requirements of their programs.

The US operation could also provide a platform for Ofichem to expand into controlled-substance activities. The company said it intends to explore establishing US capabilities in this area, subject to obtaining the necessary licences and approvals.

Dr Weite Oldenziel, CEO of the Ofichem Group, says: “The acquisition of Kinentia represents an important milestone in Ofichem’s continued development,” he said. “It strengthens our presence in the United States and complements our established European development and manufacturing capabilities.”

The acquisition will also add several scientific capabilities to Ofichem’s drug substance offering, including work involving polysaccharides, small peptides and complex new chemical entities. Ofichem already works with small molecules, highly potent compounds requiring OEB 3-5 containment, oligonucleotides and targeted protein degradation technologies such as proteolysis-targeting chimeras (PROTACs).

Alessia Cogotti, managing director of Ofichem’s Drug Substance Business Unit, says Kinentia’s expertise would broaden the group’s capabilities while giving its customers access to larger-scale manufacturing as programs mature. “For our customers, keeping scientific and process knowledge within one accountable organization provides greater continuity as programs develop,” Cogotti says. “It reduces the risks associated with handovers between independent providers and creates a more connected path from early development through to commercial manufacturing.”

The Kinentia deal follows Ofichem’s broader expansion of its pharmaceutical services network. In addition to the drug substance operations, the Ofichem Group has a Sourcing & Distribution business with operations in Ter Apel, Hangzhou in China and Hamburg in Germany. Its Drug Product business includes formulation and manufacturing operations in Nijmegen and Leiden in the Netherlands.

Ofichem said the combined capabilities will allow it to support customers across a broader portion of their chemistry, manufacturing and controls (CMC) programs, from early scientific and analytical development through process development, scale-up and GMP manufacturing.

The company characterized the Kinentia acquisition as part of a strategy of targeted investment in specialist capabilities and pharmaceutical markets, with the US expansion adding a new geographical component to that strategy.

For more information, visit www.ofichem.com.