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Biopharmaceutical Contract Manufacturing

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Showing 56 facilities
Liof Pharma S.L.U.
Spain

Liof Pharma S.L.U.

Liof Pharma S.L.U.

Socio CDMO de confianza para la fabricación aséptica y liofilización de productos biológicos y medicamentos inyectables.

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MARKETS: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), INVIMA (Colombia)

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

REGION: Europe

COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU GMP)

USE: Human, Veterinary

BSL (Biological Safety Level): 1

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING

THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents

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

BATCH SIZE: Small

CARBOGEN AMCIS | Saint-Beauzire
France

CARBOGEN AMCIS | Saint-Beauzire

CARBOGEN AMCIS

Desarrollo personalizado y producción aséptica automatizada de medicamentos líquidos y liofilizados

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

THERAPEUTIC AREAS OF EXPERTISE (ATC): (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (A) Digestive tract and metabolism

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

COMPLIANCE: French Service-Public (CIR), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority)

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC

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

REGION: Europe

USE: Human

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

CARBOGEN AMCIS | Aarau
Switzerland

CARBOGEN AMCIS | Aarau

CARBOGEN AMCIS

Desarrollo y fabricación cGMP a mediana escala, incluida la cromatografía

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MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)

REGION: Europe

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP)

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, OLIGONUCLEOTIDES, BIOLOGICS, SERVICES

USE: Human, Veterinary

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

THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

BATCH SIZE: Small, Medium

Adragos Pharma | Halden
Spain

Adragos Pharma | Halden

Adragos Pharma

Nos especializamos en la fabricación de bolsas intravenosas, ampollas y viales de plástico utilizando la tecnología Blow-Fill-Seal (BFS) y otras formas de dosif

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CONTROLLED SUBSTANCES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), TGA (Australia)

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

REGION: Europe

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP), NSF

BATCH SIZE: Large, Small, Medium

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, NUTRACEUTICALS, OLIGONUCLEOTIDES, BIOLOGICS, SERVICES

USE: Human

THERAPEUTIC AREAS OF EXPERTISE (ATC): (D) Dermatologicals, (L) Antineoplastic and immunomodulating agents, (V06) Nutrients, (A) Digestive tract and metabolism

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

CZ Vaccines | Investigational and Medicinal Products Plant
Spain

CZ Vaccines | Investigational and Medicinal Products Plant

CZ Vaccines

Instalación de Ensayos Clínicos

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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)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS

USE: Human

BSL (Biological Safety Level): 2

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

BATCH SIZE: Small

Aenova Group - Location Gronau, Germany
Germany

Aenova Group - Location Gronau, Germany

Aenova

Centro de competencia para sólidos convencionales y servicios clínicos.

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MARKETS: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, EDE (UAE)

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

REGION: Europe

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), UAE Ministry of Health & Prevention, EMA (EU GMP)

BATCH SIZE: Large, Small, Medium

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES

USE: Human, Veterinary

THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents

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

Cenexi Hérouville Saint Clair
France

Cenexi Hérouville Saint Clair

Cenexi

The Hérouville-Saint-Clair site, located near Caen, in Normandy, specializes in the manufacture and filling of injectable and non-injectable sterile liquids.

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

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), MFDS (South Korea), TGA (Australia)

REGION: Europe

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), NMPA (China GMP), EMA (EU GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS

USE: Human

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

THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (A) Digestive tract and metabolism

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

BATCH SIZE: Small, Medium

CARBOGEN AMCIS | Bubendorf
Switzerland

CARBOGEN AMCIS | Bubendorf

CARBOGEN AMCIS

Desarrollo y fabricación cGMP de API de gran potencia, incluidos conjugados anticuerpo-fármaco (ADC)

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

BATCH SIZE: Small, Medium

COMPLIANCE: EMA (EU GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP)

CATEGORY / PRODUCT: BIOLOGICS, SERVICES, CHEMICAL-SYNTHETIC

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

REGION: Europe

USE: Human, Veterinary

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

THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism

HIPRA BIOTECH SERVICES | Amer
Spain

HIPRA BIOTECH SERVICES | Amer

HIPRA Biotech Services

Capacidades internas integrales, desde el desarrollo de líneas celulares hasta la fabricación comercial

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

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

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, OLIGONUCLEOTIDES

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

USE: Human, Veterinary

BSL (Biological Safety Level): 1, 2

THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents

HIPRA BIOTECH SERVICES | Aiguaviva
Spain

HIPRA BIOTECH SERVICES | Aiguaviva

HIPRA Biotech Services

Capacidades internas de principio a fin, desde el desarrollo de líneas celulares hasta la fabricación comercial.

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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

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, OLIGONUCLEOTIDES, BIOLOGICS, SERVICES

USE: Human, Veterinary

BSL (Biological Safety Level): 1, 2

THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents

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

PRASFARMA
Spain

PRASFARMA

PRASFARMA

CMO/CDMO de citostáticos y productos de alta potencia

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OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)

BSL (Biological Safety Level): 3, 4

CONTROLLED SUBSTANCES: High potential for abuse & medical use

COMPLIANCE: ICH, ISO, ANVISA (Brazil B-GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), NMPA (China GMP), EMA (EU GMP)

MARKETS: EMA (EU), NMPA (China), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities

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

REGION: Europe

BATCH SIZE: Large, Small, Medium

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES

USE: Human

THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents

53Biologics Production Plant
Spain

53Biologics Production Plant

53Biologics

53Biologics es una CDMO espa ola especializada en descifrar la producción de biológicos, desde el ADN hasta las proteínas, proporcionando desde la fase preclíni

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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, Quality Assurance services, Regulatory services

REGION: Europe

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

BATCH SIZE: Large, Small, Medium

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, OLIGONUCLEOTIDES, BIOLOGICS, SERVICES

USE: Human, Veterinary

BSL (Biological Safety Level): 1, 2

THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents

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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.

How to Choose a Biologics CDMO

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: 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.

Key Services Offered by Biologics Contract Manufacturers

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.

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: A fully integrated biologics CDMO offering services from development to GMP manufacturing of biotherapeutics, including monoclonal antibodies and recombinant proteins. [See CDMO profile]
  • HIPRA BIOTECH SERVICES: End-to-end internal capabilities from cell line development to commercial manufacturing. [See CDMO profile]
  • Shilpa Biologicals: Supporting process development, gene-to-cell line development, GMP, formulation development, analytical development, drug substance, drug product, fill-finish, and packaging. [See CDMO profile]
  • 53Biologics: CDMO specialized in decoding biologics production, from DNA to proteins, providing from preclinical to cGMP manufacturing. [See CDMO profile]
  • Rodon Biologics: Providing excellence in biopharmaceutical product development for third parties. [See CDMO profile]
  • Histocell: CDMO that develops and manufactures cell therapies from iPSCs, MSCs, secretomes, exosomes and other cell types, as well as medical devices and dermocosmetics. [See CDMO profile]
  • VIVEbiotech: GMP-certified CDMO exclusively dedicated to lentiviral vector production. [See CDMO profile]
  • Cultiply: Developing production and purification processes for recombinant proteins, enzymes, DNA and other bioderived products. [See CDMO profile]
  • BDI Biotech: R&D-focused CDMO specializing in strain and bioprocess development, scale-up and batch production. [See CDMO profile]
  • CZ Vaccines: Comprehensive biopharmaceutical manufacturing: Upstream, Downstream, and Fill & Finish with stainless-steel bioreactors and high-capacity filling. [See CDMO profile]
  • Cambrex: Strong expertise in enzyme screening with over 800 proprietary enzymes developed across various classes. [See CDMO profile]
  • CARBOGEN AMCIS: Development and cGMP manufacturing of Highly Potent APIs including Antibody Drug Conjugates, with mid-scale cGMP manufacturing and chromatography. [See CDMO profile]
  • Aenova Group: Competence center for conventional solids and clinical services, semisolids and liquids. [See CDMO profile]
  • Lukas Heil-Betriebsstätte: High-performance production facility complying with the latest GMP standards for sterile and aseptic liquids, especially glass ampoules. [See CDMO profile]
  • Basic Pharma Manufacturing: Wide analytical testing capabilities and regulatory support tailored to client needs, following strict quality guidelines. [See CDMO profile]
  • Adragos Pharma: More than 100 years of experience delivering first-class, customer-focused pharmaceutical manufacturing. [See CDMO profile]
  • Cellex Cell Professionals: CGT CDMO with cell manufacturing plant and starting materials collection center. [See CDMO profile]
  • Ascendia Pharmaceutical Solutions: GMP-certified CDMO for advanced sterile and non-sterile manufacturing, formulation development, and analytical testing. [See CDMO profile]
  • Kemwell Biopharma Pvt Ltd: Biologics-focused CDMO offering development and manufacturing services to global biopharma organizations. [See CDMO profile]
  • Demo facility: Tissue therapy, Cell therapy and GTMP (Gene Therapy). [See CDMO profile]
  • Green Phoenix Labs GmbH: Cell Therapy company with excess Cleanroom capacity. [See CDMO profile]

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.