CDMO Activity Tracker: Axplora enhances ADC capacities, Quotient beefs up HPAPI capabilities; Evonik, EUROAPI forge deals
CDMO Activity Tracker: Axplora enhances ADC capacities, Quotient beefs up HPAPI capabilities; Evonik, EUROAPI forge deals

By PharmaCompass

2025-04-10

Impressions: 1619

The contract development and manufacturing organization (CDMO) sector witnessed significant activity in the first quarter (Q1) of 2025, characterized by strategic investments, facility expansions, and collaborative partnerships.

The quarter saw some significant deals. WuXi Biologics agreed to sell its vaccine manufacturing facility in Dundalk, Ireland, to Merck for € 500 million (US$ 521 million). Quadria Capital announced the acquisition of a 10 percent stake in Aragen for US$ 100 million. This investment will help Aragen accelerate its research and development efforts.

Some CDMOs, like India-based Syngene International and Belgium-based Ardena expanded their presence in the US market. Syngene completed the acquisition of its first US biologics facility that it had purchased from Emergent Manufacturing Operations Baltimore for US$ 36.5 million. And, leading nanomedicine developer Ardena purchased a drug manufacturing unit in New Jersey from Catalent.

View CDMO Activity Tracker for Q1 2025 (Free Excel Available)

Axplora expands its ADC capacities; Quotient Sciences wraps up HPAPI unit upgrade

The antibody-drug conjugate (ADC) market saw considerable investments by CDMOs. Axplora expanded its commercial payload production capabilities at its Le Mans site in France, reinforcing its position as a leading player in ADC manufacturing. This expansion is part of the France 2030 program and builds on Axplora’s track record of supplying 40 percent of the world’s marketed ADCs and 50 percent of ADCs approved by the US Food and Drug Administration (FDA).

Samsung Biologics said it will support a series of LigaChem Biosciences’ ADC programs at its new dedicated ADC facility. Similarly, Cerbios-Pharma announced significant enhancements to its ADC production capabilities. Cerbios also announced the expansion of its high potency active pharmaceutical ingredients (HPAPIs) production capabilities. On March 31, Cerbios-Pharma got acquired by Healthcare Advanced Synthesis, a leading developer of APIs, HPAPIs and anticancer compounds. Both these global players are based in Switzerland.

Topscience Biotech specializes in R&D, production, and sales of Sodium Hyaluronate, focusing on Medical and Pharmaceutical Grade HA.

Overall, HPAPIs saw significant investments. Quotient Sciences made headlines with the successful completion of a US$ 1.4 million project designed to improve high potency handling capabilities at its Philadelphia (US) facility. The initiative focused on upgrading infrastructure and implementing advanced safety protocols to manage HPAPIs more effectively.

Polfa Tarchomin achieved significant milestones in enhancing its pharmaceutical manufacturing capabilities. The company successfully completed the site acceptance test (SAT) for its vial filling and packaging line at the Center for Development and Production of Highly Potent Drugs, ensuring full functionality and compliance with good manufacturing practice (GMP) standards.

Additionally, Polfa Tarchomin is installing a high-tech, high-containment robotic ONCO LINE designed for aseptic production of highly potent pharmaceutical products, including lyophilisates and liquid formulations in vials and pre-filled syringes. Developed in collaboration with leading global suppliers, this line supports multiple packaging formats and comes with advanced systems. With an annual production capacity of up to 6 million units, this line will set a new benchmark in pharmaceutical manufacturing.

In a significant development for analytical testing, SK Pharmteco launched an enhanced laboratory specifically designed for HPAPIs. The new facility is in California (US).

View CDMO Activity Tracker for Q1 2025 (Free Excel Available)

Evonik expands RNA portfolio; Catalent to support Galapagos’ CAR-T therapy trials

The success of mRNA vaccines and the growing interest in RNA therapeutics is luring CDMOs to rapidly expand their capabilities in this emerging area. Evonik, in collaboration with ST Pharm, announced plans to expand its portfolio of RNA and nucleic acid therapeutic services during Q1. The partnership enables Evonik to provide customized nucleic acids from ST Pharm alongside its portfolio of lipid and lipid nanoparticle (LNP) drug product development services.

ReciBioPharm secured a grant from the Bill & Melinda Gates Foundation to advance RNA manufacturing technologies that meet FDA standards with a focus on improving access to RNA therapeutics in low- and middle-income countries.

The cell and gene therapy sector also witnessed remarkable activity in Q1 2025. Catalent announced it will support Galapagosdecentralized CAR T therapy trials for GLPG5101 for relapsed/refractory non-Hodgkin lymphoma indications.

Similarly, AGC Biologics announced it will manufacture and supply lentiviral vectors for Adaptimmune’s solid tumor cell therapy initiatives. And, Genenta and AGC Biologics strengthened their cell therapy manufacturing pact through a collaboration agreement. This grants Genenta access to the exclusive GMP suite at the AGC Biologics Cell and Gene Center of Excellence in Milan, dedicated to manufacturing cell therapy products.

View CDMO Activity Tracker for Q1 2025 (Free Excel Available)

EUROAPI, StrainChem join hands to develop peptides; Fermion expands flow chemistry capabilities

Even traditional therapeutics like peptides and small molecules saw considerable investments by CDMOs. For instance, EUROAPI and StrainChem announced a collaborative venture to develop liquid phase peptides. The partnership aims to harness advanced synthesis techniques and innovative technologies for more efficient peptide manufacturing. Through this collaboration, EUROAPI and StrainChem will offer their customers a one-stop shop solution for peptides.

Topscience Biotech specializes in R&D, production, and sales of Sodium Hyaluronate, focusing on Medical and Pharmaceutical Grade HA.

In one of the most ambitious expansions announced this quarter, CordenPharma unveiled plans to invest over € 1 billion (US$ 1.10 billion) over the next three years in building and expanding small, medium, and large peptide manufacturing facilities across Europe and the US. That includes a new greenfield facility for peptide manufacturing in the Basel region of Switzerland, valued at over € 500 million (US$ 553 million).

In obesity treatments, Viking Therapeutics agreed to pay US$ 150 million to CordenPharma for the production of its dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) agonist VK2735.

In a show of confidence, Indian CDMO Neuland Labs’ board approved a ₹ 3.42 billion (approximately US$ 42 million) capital expenditure plan. The approved capex is earmarked for enhancing the company’s peptide synthesizer reactor capacity and building additional capacity to meet growing demand.

In the small molecule space, Fermion announced a strategic investment to expand its flow chemistry capabilities, aiming to enhance processes and sustainability by integrating continuous flow techniques into manufacturing. This technology offers advantages in scalability, process control, and safety, positioning Fermion at the forefront of pharmaceutical innovation.

Recipharm announced a major expansion of its aseptic filling capabilities, encompassing process development, pilot-scale production, and clinical supply operations. Similarly, Curia announced significant expansions to its global network of sterile fill-finish sites, aiming to enhance production capacity, streamline supply chains, and improve overall quality in sterile pharmaceutical manufacturing.

View CDMO Activity Tracker for Q1 2025 (Free Excel Available)

Our view

During Q1 2025, the CDMO sector continued to evolve towards higher-value and more complex services. This only underscores the crucial role CDMOs are playing in supporting growth and innovation in the pharmaceutical industry.

With the Trump administration in the US triggering a global tariff war, drugmakers have no option but to reshape their supply chains. And this means more business for CDMOs that manufacture drugs in the US. In the coming quarter, we expect strong dealmaking and increased focus on innovation in the CDMO sector.

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Image Credit : CDMO Activity Tracker for Q1 2025 by PharmaCompass license under CC BY 2.0

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