Home / Biologics CDMO Companies | Biopharmaceutical Contract Manufacturing /
The market for complex biologics is booming, with innovative therapies demanding specialized large molecule manufacturing expertise, yet the path from cell-line development to commercial launch is anything but simple. Partnering with experienced biologics CDMO companies, experts in biopharmaceutical contract manufacturing, gives emerging and established innovators the speed, compliance, and specialized know-how they need to transform breakthrough science into approved biopharmaceutical products.
Selecting the right partner for outsourced biologics production is critical to your molecule’s success. The ideal biologics contract development and manufacturing organization should offer:
Regulatory track record: Confirm recent FDA/EMA inspections and cGMP certifications for biologic drugs.
Technical fit: Does the biologics CDMO have proven platforms for your molecule type (mAbs, recombinant proteins, viral vectors, vaccines) and similar biotherapeutics?
Scale-up flexibility: From 50 L perfusion to 20,000 L fed-batch—can they grow with you through clinical phases to commercial scale?
Analytical depth: In-house bioassays, mass spec, and process analytics shorten batch release timelines.
Culture & communication: Transparent project management and digital data-sharing tools keep cross-functional teams aligned.
Request tech transfer statistics, batch success rates, and real client references to benchmark biomanufacturing performance.
Leading providers go far beyond stainless-steel bioreactors to deliver end-to-end solutions. Core offerings typically include:
Cell-line & process development – high-throughput clone screening, media optimization, and QbD studies for robust processes.
Upstream & downstream manufacturing – single-use or hybrid suites, continuous processing, high-capacity chromatography, and viral-clearance steps tailored to your biologic product.
Fill-finish & formulation – aseptic vial, syringe, or cartridge filling plus lyophilization and advanced delivery systems.
Analytical & QC services – stability programs, impurity profiling, potency assays, and real-time release testing meeting global standards.
Regulatory & CMC support – IND/BLA dossier authoring, comparability protocols, and global tech transfer for seamless approvals.
Speed to clinic: Established platform processes can cut development timelines by 6–12 months versus in-house development.
CapEx avoidance: Outsourcing eliminates the multimillion-dollar investment and validation burden of building dedicated green-field facilities.
Scalability: Seamless transition from pilot to commercial volume within one network reduces manufacturing supply-chain risk.
Specialized talent: Access to seasoned upstream scientists, viral safety experts, and regulatory strategists with biologic-specific experience.
Global reach: Multi-site biologics CDMOs offer redundant capacity, regional fill-finish options, and worldwide cold chain logistics support.
Mabion: A fully integrated biologics 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]
HIPRA BIOTECH SERVICES: End-to-end internal biopharmaceutical contract manufacturing capabilities, from cell line development to commercial production. [See CDMO profile]
Shilpa Biologicals: A biologics 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]
53Biologics: A CDMO specialized in decoding biopharmaceutical contract manufacturing, from DNA to proteins, providing from preclinical to cGMP manufacturing. [See CDMO profile]
Histocell: A biologics CDMO that develops exosomes and secretomes as part of its cell therapies. [See CDMO profile]
VIVEbiotech: Leading GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors. [See CDMO profile]
Cultiply: CDMO that develops production and purification processes for recombinant proteins, enzymes, DNA and other bioderived products. [See CDMO profile]
BDI biotech: Works as an R&D department specialized in strain and bioprocess development, scale-up and batches production. [See CDMO profile]
Huiyu (Seacross) Pharma: Provides CMO/CDMO services for global clients. [See CDMO profile]
Ready to take the next step in your biopharmaceutical contract manufacturing journey? Use MAI CDMO’s platform to explore a global network of trusted biologic drug manufacturers. Whether you’re seeking full-scale GMP biologics production or specific development services, our platform simplifies the process of finding the perfect bioprocessing partner.
Visit MAI CDMO today to connect with the right biologics CDMO for your needs or contact us for personalized biomanufacturing strategy support.
If you have any questions or suggestions, click here. We will be happy to assist you.