Biologics Drug Product CDMOs

National Resilience Inc.

Canada

Major North American biomanufacturing CDMO (branded as 'Resilience') focused on complex medicines including large molecule biologics, cell therapies, and aseptic drug product manufacturing. Operates facilities across the US and Canada. Delivers 100+ million vials and pre-filled syringes annually. Secured $825 million in financing to accelerate CDMO strategy. Offers proprietary technology platforms including Sprout Solutions, Auto-T, DAR-T (next-gen CAR-T), and Idea to Clinic services. FDA registered with 7 FEI numbers, 17 inspections.

PSM GmbH is a German pharmaceutical CDMO specializing in aseptic fill and finish services for drugs, biologics, and biopharmaceutical products. The company offers end-to-end commercial fill and finish services with state-of-the-art flexfill filling-line technology and formulation development capabilities. Limited website data is available, but search results consistently identify PSM as a specialized aseptic fill/finish CDMO.

Stelis Biopharma is a leading, fully integrated biopharmaceutical CDMO based in India (Bangalore) with over 30 years of operational excellence. They brand themselves as 'OneSource' -- a multimodal specialty pharma CDMO with end-to-end capabilities across multiple tech platforms and therapeutic modalities. Their capabilities span biologics (microbial and mammalian cell culture, drug substance and drug product), complex sterile injectables (35 approved ANDAs and 19 commercialized drug products in the US), drug-device combinations (20+ automatic/semi-automatic assembly stations for prefilled syringes, pen injectors, autoinjectors), and soft gelatin capsules (2.4 billion per year capacity). They operate 5 state-of-the-art facilities approved by various regulatory bodies. Syngene acquired Stelis Biopharma's Unit 3 plant in Bangalore for biologics manufacturing.

Pharma Line S.r.l. is an Italian pharmaceutical company specializing in medical devices and food supplements since 1987. While listed on PharmaSource under CDMO/finished dosage forms, the company's own website is a parked domain with no manufacturing evidence. The primary business appears to be medical devices and nutraceutical supplements, not contract drug manufacturing.

Rodon Biologics is a Portuguese biotech CRO/CDMO with over 20 years of experience in biologics development and GMP manufacturing. The company specializes in recombinant protein production, antibody development, and biopharmaceutical product development for third parties. Rodon Biologics provides services from discovery research through GMP manufacturing of biopharmaceutical products.

Kaneka Eurogentec (part of Kaneka Group, Japan) is a Belgian CDMO established in 1985, FDA inspected, GMP accredited. Manufactures starting materials and APIs for clinical and commercial phases. Core products: GMP plasmid DNA (gram to kg scale), GMP recombinant proteins and antibody fragments, GMP mRNA (50g per batch, commercial-ready facility accredited June 2025), GMP oligonucleotides (pre-clinical and Phase 1/2), GMP conjugates. Also supplies research-grade oligonucleotides and diagnostic tools. 475 employees. FDA registered with 2 FEI numbers, 7 inspections (1 NAI, 6 VAI). Plasmid DNA serves as starting material for viral vector and mRNA production.

Just - Evotec Biologics (wholly owned by Evotec) is a biologics CDMO specializing in monoclonal antibodies, next-generation biologics, and biosimilar products. Differentiated by proprietary integrated end-to-end continuous manufacturing platform (J.POD) which uses perfusion cell culture with continuous purification, achieving higher output in smaller footprint than traditional batch manufacturing. Two manufacturing sites in Seattle and Redmond, WA. Offers cell line development, analytical services, process development, and early clinical through commercial cGMP manufacturing. Uses AI/ML technologies in development.

Mycenax Biotech is a Taiwan-based biologics CDMO specializing in the development and manufacturing of biosimilars, monoclonal antibodies, bispecific antibodies, ADCs, and cell & gene therapy-related products. The company provides integrated services spanning cell line development, process development, analytical services, GMP manufacturing, and regulatory support for global biotech and pharmaceutical partners. With expertise in mammalian cell culture and biologics manufacturing, Mycenax supports clients from early-stage development through commercial-scale production. The company has established GMP facilities in Taiwan and focuses on delivering flexible, high-quality manufacturing solutions for complex biologics and next-generation therapeutics.

LucasPye BIO (LPB) is a US-based CDMO focused on accelerating biotherapeutic innovation. They offer comprehensive biopharmaceutical development and manufacturing solutions including cell line development, upstream/downstream process development, and cGMP manufacturing of biologics. They aim to bring down CDMO costs through strategic vendor partnerships to make biotherapeutics more affordable.