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As vaccine technologies evolve — from traditional attenuated viruses to recombinant proteins and mRNA platforms — the role of experienced vaccines CDMO companies has never been more critical. These specialized contract development and manufacturing organizations provide the infrastructure, technical expertise, and regulatory knowledge required to bring vaccines from concept to commercial production.
Whether you´re a biotech developing a novel prophylactic or a pharmaceutical company scaling up a therapeutic vaccine, working with trusted vaccines contract manufacturing partners ensures speed, safety, and scalability.
Choosing the right vaccines CDMO is essential for successful development, scale-up, and regulatory approval. Key factors to evaluate include:
Platform experience: Proven capabilities in live-attenuated, inactivated, subunit, viral vector, or mRNA vaccine platforms
Process development expertise: Strong support for upstream (cell culture, fermentation) and downstream (purification, formulation) workflows
Fill-finish capabilities: Sterile vialing or prefilled syringes in compliance with GMP standards
Regulatory readiness: Experience with FDA, EMA, WHO PQ, and global health agency approvals
Cold chain management: Support for ultra-low temperature storage and distribution
Clinical to commercial scalability: Capacity to transition smoothly through development phases
Working with a CDMO that aligns with your platform and regulatory path greatly reduces time and risk.
Top-tier vaccines contract manufacturing providers typically offer:
Cell line and virus seed development
Upstream production using Vero, CHO, HEK293, or E. coli systems
Purification and inactivation processes tailored to vaccine modality
mRNA synthesis and LNP formulation
Sterile fill-finish, visual inspection, and labeling
Analytical development and QC testing (e.g., potency, endotoxins, sterility)
GMP manufacturing for clinical trial material and commercial launch
Global regulatory support and dossier preparation
These services support the full lifecycle of vaccine development, from early research through global distribution.
Choosing specialized vaccines CDMO companies provides measurable benefits:
Platform versatility across viral, bacterial, recombinant, and nucleic acid vaccines
Faster time to clinic through integrated development and manufacturing processes
Access to proprietary technologies such as adjuvants or nanoparticle delivery
Strong regulatory track record with approvals in major markets
Reliable global supply chain and cold chain infrastructure
These CDMOs serve as strategic partners — not just manufacturers — enabling innovation and global access.
53Biologics: CDMO specialized in decoding biologics production, from DNA to proteins, providing from preclinical to cGMP manufacturing. [See CDMO profile]
Mabion: Fully integrated CDMO offering a wide services associated with the development and GMP manufacturing of biotherapeutics, including monoclonal antibodies and any recombinant protein-based products. [See CDMO profile]
Shilpa Biologicals: CDMO which support Process Development, Gene to Cell Line Development to GMP to Formulation Development, Analytical Development, Process Development, Drug Substance, Drug Product, Fill-Finish and Packaging. [See CDMO profile]
HIPRA BIOTECH SERVICES: End-to-end internal capabilities from cell line development to commercial manufacturing. [See CDMO profile]
At MAI CDMO, we connect companies with the most capable vaccines CDMO companies worldwide — whether you´re producing a next-gen mRNA vaccine or scaling a live-attenuated product. Our network of vaccines contract manufacturing partners is built to help you meet development timelines, quality requirements, and regulatory expectations with confidence.
Need a reliable vaccine manufacturing partner? Contact us today to find the right fit for your platform and pipeline.
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