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Abs CDMO Companies
Antibodies Contract Manufacturing Services

Your Trusted Partners for Antibodies Contract Manufacturing and Development

Showing 23 facilities
HIPRA BIOTECH SERVICES | Amer
Spain

HIPRA BIOTECH SERVICES | Amer

HIPRA Biotech Services

End-to-end internal capabilities from cell line development to commercial manufacturing.

MARKETS: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, BIOLOGICS

COMPLIANCE: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), DIGEMID, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), FDA (cGMP), ISO, INVIMA, Health Canada (Canada GMP), MSPAS, COFEPRIS

REGION: Europe

USE: Human, Veterinary

SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

BSL (Biological Safety Level): 1, 2

53Biologics Production Plant
Spain

53Biologics Production Plant

53Biologics

53Biologics is a Spanish CDMO specialized in decoding the production of biologicals, from DNA to proteins.

MARKETS: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), TGA (Australia), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)

BATCH SIZE: Small, Medium, Large

COMPLIANCE: EMA (EU GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO

REGION: Europe

USE: Human, Veterinary

SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Quality Assurance services

CATEGORY / PRODUCT: BIOLOGICS

BSL (Biological Safety Level): 1, 2

Cultiply
Spain

Cultiply

Cultiply

Spanish CDMO that develops production and purification processes for recombinant proteins, enzymes, DNA and other bioderived products.

MARKETS: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)

BATCH SIZE: Small, Medium

CONTROLLED SUBSTANCES: Lowest potential for abuse

REGION: Europe

SERVICES: Manufacturing services, Development services

CATEGORY / PRODUCT: BIOLOGICS

BSL (Biological Safety Level): 1, 2

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)

COMPLIANCE: ISO

Rodon Biologics
Portugal

Rodon Biologics

Rodon Biologics - RDN Serviços de Biotecnologia

Rodon Biologics provides excellence in the development of biopharmaceutical products for third parties.

BATCH SIZE: Small

CATEGORY / PRODUCT: SERVICES, BIOLOGICS, NUTRACEUTICALS

REGION: Europe

SERVICES: Analytical / QC services, Development services

BSL (Biological Safety Level): 1, 2

HIPRA BIOTECH SERVICES | Aiguaviva
Spain

HIPRA BIOTECH SERVICES | Aiguaviva

HIPRA Biotech Services

End-to-end internal capabilities from cell line development to commercial manufacturing.

MARKETS: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)

BATCH SIZE: Small, Medium, Large

COMPLIANCE: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), DIGEMID, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), FDA (cGMP), ISO, INVIMA, Health Canada (Canada GMP), MSPAS, COFEPRIS

REGION: Europe

USE: Human

SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

CATEGORY / PRODUCT: BIOLOGICS

BSL (Biological Safety Level): 1, 2

CZ Vaccines | Large Scale Plant Portugal
Portugal

CZ Vaccines | Large Scale Plant Portugal

CZ Vaccines

Commercial Scale Facility

BATCH SIZE: Medium, Large

THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, BIOLOGICS

COMPLIANCE: EMA (EU GMP), World Health Organization (GMP / HACCP), ISO

REGION: Europe

USE: Human

SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services

BSL (Biological Safety Level): 1, 2

MARKETS: EMA (EU)

CZ Vaccines | Large Scale Plant Spain
Spain

CZ Vaccines | Large Scale Plant Spain

CZ Vaccines

Single Use Commercial Scale Facility

BATCH SIZE: Medium, Large

THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (N) Nervous system

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, BIOLOGICS

COMPLIANCE: EMA (EU GMP), World Health Organization (GMP / HACCP), ISO

REGION: Europe

USE: Human

SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Packaging, Quality Assurance services

BSL (Biological Safety Level): 1, 2

MARKETS: EMA (EU)

Limited view

FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Contract Development and Manufacturing Organization (CDMO) with a focus on recombinant proteins and monoclonal antibodies (mAbs).

Location available after registration

Limited view

FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Creative Biostructure was founded with a strong focus on structural biology and membrane protein research.

Location available after registration

Limited view

BIOLOGICS manufacturing site

MAI network supplier

Mabion is a European biologics development and manufacturing partner focused on biosimilar, large molecule manufacturing, and innovation programs.

Location available after registration

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With the growing importance of biologics in treating cancer, autoimmune diseases, and infectious conditions, the demand for specialized Abs CDMO companies is higher than ever. These contract development and manufacturing organizations focus on antibodies — including monoclonal, polyclonal, bispecific, and recombinant forms — and play a critical role in translating lab-scale innovations into scalable, compliant products.

Partnering with experts in antibodies contract manufacturing ensures your therapeutic antibodies are developed and produced with the precision, speed, and quality required by global regulatory agencies and competitive markets.

How to Choose Abs CDMO Companies

When selecting among Abs CDMO companies, consider the following:

  • Antibody specialization: Experience with monoclonal, bispecific, or recombinant antibodies relevant to your pipeline
  • Cell line development: Strong capabilities in CHO cell line engineering and clone selection
  • Upstream and downstream integration: Robust fermentation and purification processes with high yields and purity
  • Analytical depth: Advanced testing for aggregation, binding affinity, and glycosylation profiling
  • Scalability: Ability to support both clinical batches and full commercial-scale production
  • Regulatory track record: CDMOs with past success in filing INDs, BLAs, and global biologics dossiers

Choosing a partner aligned with your antibody format and clinical stage reduces development risk and streamlines commercialization.

Key Services Offered by Antibodies Contract Manufacturers

Top-tier services in antibodies contract manufacturing include:

  • Cell line development: Using CHO, HEK293, or other mammalian expression systems
  • Upstream process development: Including fed-batch and perfusion cultures
  • Downstream purification: Using Protein A, ion exchange, and polishing chromatography
  • Formulation and stability optimization: For therapeutic Abs
  • Analytical characterization: Including ELISA, SEC, SDS-PAGE, and binding assays
  • GMP manufacturing: For clinical and commercial phases
  • Regulatory support: For CMC dossier preparation and audits

Many also offer high-concentration formulation services for subcutaneous delivery, a growing trend in antibody-based therapies.

Advantages of Partnering with Abs CDMO Companies

Working with experienced Abs CDMO companies provides strategic and technical benefits:

  • Reduced development time: With optimized platforms and proven processes
  • Cost-effective scalability: Using high-yield expression systems
  • Custom solutions: For different antibody formats including ADCs and bispecifics
  • Regulatory confidence: From experienced documentation and quality teams
  • Faster market access: Through integrated development-to-manufacturing workflows

These partners are essential for navigating the complexity of biologics manufacturing in a fast-moving global market.

Abs CDMO Companies

Some of the leading Abs CDMO companies include:

  • 53Biologics: Spanish CDMO specialized in decoding biologics production, from DNA to proteins, providing services from preclinical to cGMP manufacturing. [See CDMO profile]
  • Mabion: Fully integrated CDMO offering comprehensive services for the development and GMP manufacturing of biotherapeutics, including antibody contract manufacturing. [See CDMO profile]
  • Shilpa Biologicals: Abs CDMO supporting process development from gene and cell line creation to GMP manufacturing, formulation, analytics, 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]
  • Cultiply: Develops advanced production and purification processes for recombinant proteins, enzymes, DNA, and other bioderived products. [See CDMO profile]
  • Rodon Biologics: Portuguese CDMO providing excellence in the development and manufacturing of biopharmaceutical products for third parties. [See CDMO profile]
  • SINOWAY INDUSTRIAL CO: One-stop CDMO solutions provider for APIs and key intermediates, offering fully integrated development and manufacturing services. [See CDMO profile]
  • CZ Vaccines: Commercial-scale CDMO facility specializing in the production of vaccines and biologics under stringent GMP standards. [See CDMO profile]
  • Kemwell Biopharma Pvt Ltd: Biologics-focused Contract Development and Manufacturing Organization (CDMO) providing integrated development and manufacturing services to global biopharmaceutical organisations. [See CDMO profile]
  • Related Information

    Let MAI CDMO Network Help You Find the Right Abs CDMO Partner

    At MAI CDMO, we simplify the process of finding top Abs CDMO companies that match your antibody’s format, development stage, and production goals. Whether you’re advancing a monoclonal, bispecific, or recombinant antibody, we can also help identify trusted experts in antibodies contract manufacturing with the infrastructure and regulatory readiness to deliver.

    Looking for a partner to accelerate your antibody program? Contact us today to find your match.