Biologics CDMO Companies|
Biopharmaceutical Contract Manufacturing

Your Trusted Partners for Biopharmaceutical Contract Manufacturing and Development

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Spain

BDI biotech Production Plant

BDI biotech

We work as an R&D department specialized in strain and bioprocess development, scale-up and batches production.

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

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

REGION: Europe

COMPLIANCE: ISO

BSL (Biological Safety Level): 1

BATCH SIZE: Small, Medium

CATEGORY / PRODUCT: BIOLOGICS

Spain

53Biologics Production Plant

53Biologics

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

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

REGION: Europe

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

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

BSL (Biological Safety Level): 1, 2

CATEGORY / PRODUCT: BIOLOGICS

Spain

HIPRA BIOTECH SERVICES | Amer

HIPRA Biotech Services

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

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

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

REGION: Europe

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

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

BSL (Biological Safety Level): 1, 2

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

CATEGORY / PRODUCT: BIOLOGICS, FDF / DRUG PRODUCTS

Belgium

White Raven - Legiapark

White Raven

Fill and finish site dedicated to GMP Formulation and the Aseptic filling of Sterile Liquid Injectables.

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OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

MARKETS: EMA (EU)

REGION: Europe

USE: Human

BSL (Biological Safety Level): 1, 2

SERVICES: Manufacturing services, Packaging

BATCH SIZE: Small, Medium

COMPLIANCE: EMA (EU GMP)

CATEGORY / PRODUCT: BIOLOGICS, FDF / DRUG PRODUCTS

Spain

VIVEbiotech

Your leading GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors.

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MARKETS: EMA (EU), FDA (USA), MHRA (UK)

REGION: Europe

COMPLIANCE: FDA (cGMP), French Service-Public (CIR), EMA (EU GMP), MHRA (UK GMP)

BATCH SIZE: Large, Small, Medium

USE: Human

BSL (Biological Safety Level): 1, 2

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

CATEGORY / PRODUCT: BIOLOGICS

United Kingdom

Upperton Pharma Solutions

Development and manufacturing of oral solid dose (OSD), nasal, inhalation, and sterile dry powders and liquids drug products.

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CONTROLLED SUBSTANCES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, High potential for abuse & no medical use, Lower potential for abuse

MARKETS: EMA (EU), FDA (USA), Health Canada (Canada), MHRA (UK), TGA (Australia)

REGION: Europe

USE: Human

CATEGORY / PRODUCT: OLIGONUCLEOTIDES, BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS

BSL (Biological Safety Level): 1

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

THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (N) Nervous system, (R) Respiratory system

BATCH SIZE: Small, Medium

COMPLIANCE: MHRA (UK GMP)

Portugal

Rodon Biologics

Rodon Biologics - RDN Serviços de Biotecnologia

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

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REGION: Europe

CATEGORY / PRODUCT: NUTRACEUTICALS, BIOLOGICS, SERVICES

BSL (Biological Safety Level): 1, 2

SERVICES: Development services, Analytical / QC services

BATCH SIZE: Small

Spain

HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes

HISTOCELL

Histocell is a Spanish CDMO that develops and manufactures cell therapies, secretomes and exosomes, as well medical devices.

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

REGION: Europe

COMPLIANCE: ISO, EMA (EU GMP)

CATEGORY / PRODUCT: COSMETICS, BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS

USE: Human, Veterinary

BSL (Biological Safety Level): 1, 2

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

THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (B) Blood and blood forming organs, (A) Digestive tract and metabolism

BATCH SIZE: Small, Medium

Spain

HIPRA BIOTECH SERVICES | Aiguaviva

HIPRA Biotech Services

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

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

REGION: Europe

BATCH SIZE: Large, Small, Medium

USE: Human

BSL (Biological Safety Level): 1, 2

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

CATEGORY / PRODUCT: BIOLOGICS

Portugal

CZ Vaccines | Large Scale Plant Portugal

CZ Vaccines

Commercial Scale Facility

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MARKETS: EMA (EU)

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

REGION: Europe

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

BATCH SIZE: Large, Medium

USE: Human

BSL (Biological Safety Level): 1, 2

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

CATEGORY / PRODUCT: BIOLOGICS, FDF / DRUG PRODUCTS

Spain

CZ Vaccines | Investigational and Medicinal Products Plant

CZ Vaccines

Clinical Trials Facility

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MARKETS: EMA (EU), ANVISA (Brazil), CDSCO (India)

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

REGION: Europe

COMPLIANCE: ISO, ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

USE: Human

BSL (Biological Safety Level): 1, 2

THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

BATCH SIZE: Small

CATEGORY / PRODUCT: BIOLOGICS, FDF / DRUG PRODUCTS

Spain

CZ Vaccines | Large Scale Plant Spain

CZ Vaccines

Single Use Commercial Scale Facility

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MARKETS: EMA (EU)

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

REGION: Europe

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

BATCH SIZE: Large, Medium

USE: Human

BSL (Biological Safety Level): 1, 2

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

CATEGORY / PRODUCT: BIOLOGICS, FDF / DRUG PRODUCTS

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Biologics CDMO Companies

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. This is equally true for advanced therapy developers seeking a dedicated biotech CDMO with niche platform expertise.

1How to Choose a Biologics CDMO

Regulatory track record:

Confirm recent FDA/EMA inspections and cGMP certifications for biologic drugs.

Technical fit:

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.

2Key Services Offered by Biologics Contract Manufacturers

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.

Advantages of Partnering with Biologics CDMOs

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 facilities.

Scalability:

Seamless transition from pilot to commercial volume within one network reduces 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.

Top Biologics CDMO Companies

Mabion

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HIPRA BIOTECH SERVICES

Shilpa Biologicals

53Biologics

Rodon Biologics

Histocell

VIVEbiotech

Related Information

Find Your Ideal Biopharmaceutical Contract Manufacturing Partner

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 finding the perfect bioprocessing partner, including specialized biotech CDMO providers for advanced modalities.

Visit MAI CDMO Network today to connect with the right biologics CDMO for your needs or contact us for personalized biomanufacturing strategy support.

Biologics CDMO Companies

Biologics CDMO Companies|Biopharmaceutical Contract Manufacturing

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Biologics CDMO Companies

1How to Choose a Biologics CDMO

2Key Services Offered by Biologics Contract Manufacturers

Advantages of Partnering with Biologics CDMOs

Top Biologics CDMO Companies

Related Information

Find Your Ideal Biopharmaceutical Contract Manufacturing Partner

Filters

More facilities on the network

Biologics CDMO Companies

1How to Choose a Biologics CDMO

2Key Services Offered by Biologics Contract Manufacturers

Advantages of Partnering with Biologics CDMOs

Top Biologics CDMO Companies

Related Information

Find Your Ideal Biopharmaceutical Contract Manufacturing Partner

Biologics CDMO Companies|
Biopharmaceutical Contract Manufacturing