Biologics Drug Product CDMOs

GP Pharm S.A.

Spain

GP Pharm S.A. is a Spanish CDMO specializing in sterile injectable manufacturing, with particular expertise in long-acting injectable depot formulations including microspheres and sustained-release systems. The company offers contract development and manufacturing services from formulation development through commercial production, with capabilities in aseptic processing, fill/finish for vials and pre-filled syringes, and lyophilization.

Helix Biotech, Inc.

United States

Helix Biotech, Inc. is a U.S.-based CDMO specializing in GMP formulation and RNA manufacturing, including DNA, RNA, and LNP (lipid nanoparticle) formulations. The company offers end-to-end services from RNA construct design through its StrandSolve platform to GMP manufacturing via its NOVA IJM nanoparticle formulation platform.

Helvetic BioPharma SA

Switzerland

Helvetic BioPharma SA is a Swiss biopharmaceutical company based in Mezzovico, Ticino, specialized in the manufacturing of biological high-value products and active compounds. The company offers CMO bioprocessing services including mammalian cell culture and microbial fermentation. Its product portfolio includes recombinant proteins, hormones, and peptides, with PEGylation capabilities for long-acting molecules.

Hitech Health

Ireland

HiTech Health is an Irish CDMO specializing in GMP sterile manufacturing for advanced therapies including cell and gene therapies. The company provides clinical-scale aseptic fill-finish of vials and bags, Qualified Person (QP) release services for EU and UK markets, regulatory support, and end-to-end supply chain management. HiTech Health recently opened a new advanced therapy manufacturing center in Galway, Ireland.

Kemwell Biopharma Private Limited

India

Kemwell Biopharma is one of India's largest biologics CDMOs, providing integrated drug substance and drug product development and manufacturing services from a single site in Bangalore. Established with technological support from a leading German biopharmaceutical company, Kemwell serves global pharma and biotech organizations with capabilities spanning monoclonal antibodies, complex fusion proteins, recombinant proteins, and bispecific antibodies. The company has received U.S. FDA approval for commercial drug product manufacturing and operates hybrid biomanufacturing with both stainless steel and single-use bioreactor systems.

List Biological Laboratories Inc

United States

List Biological Laboratories Inc (List Labs) is a US-based CDMO with over 45 years of experience specializing in microbial-derived biologics and live biotherapeutic products (LBPs). The company provides cGMP manufacturing services for bacterial fermentation, harvest, purification, lyophilization, and encapsulation of therapeutic and vaccine products including polysaccharides, toxins, toxoids, and recombinant proteins. List Labs also manufactures nearly 100 research reagents.

medac GmbH (medac CDMO)

Germany

medac GmbH operates a dedicated CDMO division (medac CDMO) offering end-to-end sterile injectable manufacturing services from clinical supply through large-scale commercial production. Based in Germany with facilities in Wedel and Dessau (Germany) and Brno (Czech Republic), medac specializes in small molecules, biologics (mAbs, proteins, peptides, oligonucleotides), and ADCs. They handle aseptic filling, terminal sterilization, lyophilization, and high-potent API processing down to OEL = 10 ng/m3. Manufacturing scales range from 1-50 L (small) to 50-1,500 L (large) with campaigns up to 11,000 L. They partner with Cerbios under the PROVEO brand for integrated ADC services. Over 40 years of regulatory expertise with approvals from multiple international health authorities.

Microbiosci (Creative Biogene)

United States

Microbiosci (Creative Biogene) is a US-based biotech CDMO specializing in microbial fermentation-based production of commercial biological substances. The company provides GMP manufacturing services for recombinant proteins, recombinant pharmaceutical proteins, monoclonal antibodies, nucleic acid drugs, APIs, peptides, microbial metabolites, and enzymes. Their integrated platform includes strain development, fermentation process development, upstream/downstream processing, and fill-finish services.

Minaris Advanced Therapies

United States

Minaris Advanced Therapies (formerly Hitachi Chemical Advanced Therapeutics Solutions) is a global cell and gene therapy CDMO with 25+ years of autologous expertise. The company provides end-to-end GMP manufacturing and advanced testing services for gene-edited autologous (CAR-T, TCR-T), allogeneic (NK, HSC, iPSC), non-edited cell therapies, and vaccines. FDA-registered manufacturing site with FEI number.

Northway Biotech

Lithuania

Northway Biotech is a global end-to-end biologics CDMO specializing in protein-based biologics and gene therapies. The company operates state-of-the-art facilities in Vilnius, Lithuania (EU) and Waltham, Massachusetts (US), with 20+ years of technical expertise. Northway offers cell line development, process development, analytical development, and cGMP manufacturing of drug substances and drug products using both mammalian cell culture and microbial fermentation technologies.

NorthX Biologics

Sweden

NorthX Biologics is a Swedish CDMO specializing in advanced biologics and ATMPs (Advanced Therapy Medicinal Products). The company offers end-to-end services from process development to GMP manufacturing for recombinant proteins, viral vectors, plasmid DNA, cell therapy, extracellular vesicles, and mRNA. Recognized by the Swedish Government as an international competence center and innovation hub in 2021, NorthX has 30+ years of GMP manufacturing experience.

OmniaBio Inc

Canada

OmniaBio Inc is Canada's largest cell and gene therapy CDMO, established by CCRM in 2022. The company provides end-to-end contract development and manufacturing services for autologous and allogeneic cell therapies, lentiviral vectors, and immunotherapies. Its Hamilton, Ontario facility integrates AI, automation, and robotics to enhance manufacturing efficiency and reduce costs.

OneSource Specialty Pharma Limited

India

OneSource Specialty Pharma Limited (formerly Stelis Biopharma Limited) is India's first specialty pharma pure-play CDMO, offering multimodal end-to-end capabilities across drug-device combinations, complex sterile injectables, biologics, and soft gelatin capsules. The company operates five state-of-the-art facilities in Bengaluru with 35 approved ANDAs and 19 commercialized drug products in the US market.

Recipharm AB

Sweden

Rechon Life Science AB is a subsidiary/entity within the Recipharm group, the global CDMO headquartered in Stockholm, Sweden. This entry represents the same Recipharm organization (same website: recipharm.com) with its extensive global manufacturing footprint of 15+ FDA-registered FEI numbers and 52 FDA inspections. The Perplexity research confirms Recipharm's specialization in oral solid dose, inhalation, sterile manufacturing, and HPAPI capabilities. Rechon may represent a specific Recipharm site or legacy entity. Duplicate of Recipharm AB entry -- capabilities are identical.

ReiThera Srl

Italy

ReiThera is an Italian CDMO dedicated to process development and GMP manufacturing of viral vectors for genetic vaccines and advanced therapy medicinal products (ATMPs). They have extensive expertise in developing scalable processes for Adeno-Associated Vectors (AAV), Lentivirus, Adenoviral vectors (AdV), Modified Vaccinia Ankara, and Herpes Simplex Vectors. Their state-of-the-art facility in Rome features stirred-tank bioreactors at 50L, 200L, 1000L, and 2000L scales, fixed-bed bioreactors, a filling suite, and quality control laboratories. They also develop their own vaccine candidates (e.g., GRAd-COV2).

Rezon Bio

Poland

Rezon Bio is a European biologics CDMO headquartered in Poland, specializing in mammalian drug substance development and GMP manufacturing. The company operates two FDA-approved facilities with mirrored capabilities, employs approximately 1,300 people (10% PhDs), and has 16 years of biologics development experience. Rezon Bio offers end-to-end services from cell line development through commercial manufacturing with 2,000L bioreactors.

Scinai Immunotherapeutics

Israel

Scinai Immunotherapeutics is a NASDAQ-listed biopharmaceutical company that provides boutique biologics CDMO services through its Scinai Bioservices business unit, alongside its own I&I therapeutics pipeline. The CDMO offers end-to-end drug development and manufacturing from molecule selection through Phase 3 manufacturing, with over 20 years of experience in recombinant protein development. Scinai acquired a manufacturing site in Yavne, Israel from Recipharm and established a US subsidiary (Scinai Bioservices Inc.).

Scorpius BioManufacturing

United States

Scorpius BioManufacturing is a US-based biologics CDMO focused on mammalian, microbial, and cell therapy manufacturing. The company provides cGMP manufacturing, bioanalytical, and process development services from its San Antonio, Texas facility. Note: Tivic Health acquired manufacturing assets from Scorpius, and the company has undergone corporate restructuring under Scorpius Holdings / NightHawk Biosciences.

STC Biologics

United States

STC Biologics, Inc. is a boutique turn-key biologics CDMO located in Newton, Massachusetts, USA, founded in 2009. The company provides full CMC services and consulting to enable partners to advance biologic products from discovery to commercialization. Their team brings expertise from Genentech, Novartis, Shire, EMD Serono, Lonza, Alexion, and Merrimack. STC offers a Speed-To-Clinic Platform for monoclonal antibodies that can go from royalty-free cell line development directly to cGMP manufacturing and released drug substance within 12 months. They opened a single-use mammalian GMP facility in 2019 and have filed 8+ BLAs, dozens of INDs, and 20+ comparability protocols. They also developed their own biosimilar product, STC101.

3PBiovian

Finland

3P Biovian is a global biologics CDMO providing end-to-end services from early-stage development to commercialization. They specialize in proteins, viral vectors, plasmid DNA, and cell therapy products with cGMP manufacturing facilities in Turku, Finland, and Pamplona-Noain, Spain. The company has invested over 50 million euros in facility expansion.

53 Biologics

Spain

53 Biologics is a Spanish CDMO specializing in biologics production from plasmid DNA to proteins. They provide services from preclinical development to cGMP manufacturing, with over 4,500 sqm of facilities including microbial and mammalian manufacturing lines. They hold ISO 9001, ISO 13485, ISO 14001 certifications and operate under GMP.

Advaxia Biologics is a CDMO near Rome, Italy, specializing in adenovirus vaccine development and cGMP manufacturing. With over 10 years of biologics expertise and a 100% batch approval rate, Advaxia provides fully integrated services from expression systems and process development to analytical development and GMP manufacturing, and is EMA, FDA, and AIFA compliant.

Contract Packaging Resources is a member of the Aenova Group, a worldwide leading CDMO for the pharmaceutical and healthcare industry. The Aenova Group provides comprehensive pharmaceutical manufacturing including solid dosage forms, sterile fill and finish, semi-solids, non-sterile liquids, softgels, gummies, and packaging services. The Latina site in Italy serves as the central sterile manufacturing facility with capacity for over 100 million units per year, handling biologics including monoclonal antibodies, peptides, and vaccines with isolator technology.

AMPAC Analytical is part of SK pharmteco, a major integrated CDMO providing custom small molecule API development and manufacturing, viral vector and gene therapy CDMO services, and comprehensive analytical testing. SK pharmteco operates FDA/EMA/PMDA-inspected facilities across the US, Korea, Ireland, and France with capabilities spanning from clinical trials through commercial scale manufacturing.

Bacthera was a specialized CDMO focused on live biotherapeutic products (LBPs) and microbiome-based therapeutics, operating as a joint venture that originated from Lonza and Chr. Hansen. The company provided development and cGMP manufacturing services across the live biotherapeutics value chain, from drug substance production through drug product manufacturing. Bacthera collaborated with Seres Therapeutics for commercial manufacturing of SER-109 (a treatment for recurrent C. difficile infection), acquired a cGMP site in Leon, Spain, and received regulatory approvals from Swissmedic and the Danish Medicines Agency. However, Bacthera ceased its CDMO operations by September 2025, with its equipment subsequently acquired by EXPERT'Biome (Lallemand's CDMO division). Note: this company has closed its CDMO operations.

Biotimize – Biotechnology as a Service (BTaaS)

Brazil

Biotimize is the first CDMO for biopharmaceuticals in Brazil, dedicated to maximizing the development and production of biopharmaceuticals. The company provides personalized biotechnology and bioprocess engineering-based services (currently non-GMP) to biopharmaceutical companies and is building a new GMP production platform on over 20,000 square meters. Biotimize offers bioproduct development and biotechnology-as-a-service (BTaaS).

Cytovance Biologics

United States

Cytovance Biologics is a biopharmaceutical CDMO based in Oklahoma City, USA, specializing in the production of therapeutic proteins and antibodies from both mammalian and microbial expression systems. The company recently expanded its services to include in-house formulation development and pDNA production for gene therapy developers. Cytovance is FDA-registered with 2 inspections (NAI and VAI) and celebrates over 20 years in operation.

Eurofins Biopharma Services (CDMO)

Australia

Eurofins Biopharma Services CDMO is a division of Eurofins Scientific offering integrated API and drug product outsourcing services across small molecules and biologics. The company provides services from early-stage development through commercial manufacturing including highly potent drug development, sterile manufacturing/fill-finish, lyophilization, and biologics development through its Alphora brand.

Euticals (now part of Curia)

France

Euticals, now part of Curia Global, is a global CDMO with over 30 years of experience in drug discovery, development, and manufacturing across small molecules, generic APIs, sterile drug products, and biologics. Curia (which acquired Euticals through AMRI) operates an extensive global network with hundreds of FDA-registered facilities and provides end-to-end services from API manufacturing through sterile fill/finish.

Evotec

France

Evotec is a life science company with drug discovery CRO services and a biologics CDMO division (Just - Evotec Biologics). Just - Evotec Biologics operates cGMP manufacturing facilities in Seattle and Redmond, WA, specializing in continuous biomanufacturing of antibodies, next-generation biologics, and biosimilars using its proprietary J.POD modular facility design.

GC Biopharma

South Korea

GC Biopharma is a South Korean biopharmaceutical company specializing in vaccines, plasma-derived therapies, and biologics. The company provides Vial and Pre-Filled Syringe (PFS) Fill & Finish CMO services and drug product (DP) manufacturing as CDMO services. GC Biopharma has established an mRNA production facility at its Hwasun plant and operates multiple manufacturing sites including Ochang, Hwasun, and Eumseong plants.

GTP Bioways

France

Duplicate entry of GTP Bioways (company ID 1f8658ec). GTP Bioways, acquired by Olon Group in 2024, is a French biologics CDMO specializing in process development and GMP manufacturing of monoclonal antibodies, recombinant proteins, bispecifics, ADCs, and nanodrugs across four sites in France.

Histocell

Spain

Histocell is a Spanish clinical-stage biopharmaceutical company and CDMO specializing in regenerative medicine and advanced therapy medicinal products (ATMPs). Based in the Basque Country, the company develops and manufactures cell therapy products from iPSCs, MSCs, secretomes, and exosomes. Histocell recently achieved GMP certification from AEMPS for iPSC manufacturing in partnership with REPROCELL, and has produced over 350 GMP batches treating approximately 300 patients from its 800 m2 EMA-registered facility.

Leanbio

Spain

Leanbio is a Spanish biopharmaceutical CDMO founded in 2014 by Dr. Andreu Soldevila and Albert Font, specializing in end-to-end development and manufacturing of biological products including recombinant proteins, antibodies, bioconjugates, and mRNA. Offers both microbial and mammalian production platforms. Acquired by Reig Jofre to strengthen their CDMO capabilities. Currently building a new GMP biologics facility in Sant Quirze del Valles, Barcelona, with an additional 20M EUR investment, featuring over 4,000 sqm and three manufacturing areas: one each for microbial, mammalian, and mRNA production.

Pace Life Sciences is a division of Pace Analytical Services LLC, operating as a full-service CDMO/CRO network across the United States. The company supports drug development across the entire lifecycle from preclinical research through commercialization, specializing in small molecules, biologics (proteins, peptides, monoclonal antibodies, ADCs), nucleic acids (oligonucleotides, mRNA, plasmid DNA), and gene therapies. Recognized by PharmaSource as a Top CDMO in the United States. Operates 9+ strategically located sites including a sterile fill-finish Center of Excellence in Salem, NH.

Paras Biopharmaceuticals Finland Oy

Finland

Paras Biopharmaceuticals Finland Oy is a Finnish biologics CDMO based in Oulu, Finland, specializing in contract development and microbial biologics manufacturing. The company has a fully owned 25,000 sq ft state-of-the-art biologics production plant. Major activities include Biologics CDMO services and biologics technology development, including the proprietary Diabrid Platform. Recognized as one of the fastest-growing companies in Nordic biotechnology. Currently investing in expansion of its Oulu production site.

Division of Terumo Corporation (TSE:4543), a global healthcare technology leader since 1921 with 30,000+ employees. Provides sterile injectable contract development and manufacturing (CDMO) services from combination device design and formulation development to commercial manufacturing. Offers a portfolio of injection, infusion, and primary packaging solutions including PLAJEX polymer pre-fillable syringes, Immucise intradermal injection systems, hypodermic needles, and Surflo winged infusion sets. Recently expanded CDMO services outside Japan for global market and is doubling capacity.

TOT BIOPHARM is a China-based biopharmaceutical CDMO headquartered in Suzhou Industrial Park, providing end-to-end CDMO services with established technology platforms focused on biologics and ADC manufacturing. The company operates a large-scale GMP-compliant commercial production base with 20,000L monoclonal antibody drug substance capacity, and has achieved PMDA (Japan) accreditation. Listed on HKEX (1875.HK).

Duplicate entry for VGXI Inc (see companyId 58cac364). Same company -- leading plasmid DNA CDMO in Texas. Same website URL (vgxii.com). Same capabilities, facilities, and services.

Vibalogics is a specialized global CDMO for virotherapy manufacturing, now operating as Recipharm Advanced Bio after acquisition by Recipharm AB. The company offers process and analytical development, GMP manufacturing of viral vectors, oncolytic viruses, and advanced therapies. Capabilities include xRNA therapies, viral vectors (AAV, lentivirus), microbial/live biotherapeutic products, recombinant proteins, plasmid DNA, and lipid nanoparticles. Major $50M expansion of Cuxhaven facility (500L manufacturing line) completed. 118,000 sq ft GMP facility in Massachusetts (US) also completed.

FUJIFILM Biotechnologies (formerly FUJIFILM Diosynth Biotechnologies) is a global biologics CDMO operating 10 facilities across the US, UK, Denmark, and Japan with over 4,800 employees. The company provides end-to-end cGMP manufacturing services for biologics, advanced therapies, and vaccines, from preclinical through commercialization, with $8.6 billion invested in recent years and 20+ commercial licenses.

Goodwin Biotechnology (GBI) is a full-service biopharmaceutical CDMO based in Florida, specializing in biologics development and manufacturing. Named Manufacturer of the Year by BioFlorida, GBI offers its Single-Source Solution for monoclonal antibodies, ADCs, recombinant proteins, and other complex biologics from cell line development through cGMP commercial manufacturing. The company provides mammalian cell culture manufacturing using CHO and other expression systems.

JSR Life Sciences (KBI Biopharma / Selexis)

Switzerland

JSR Life Sciences is the parent organization of KBI Biopharma (CDMO) and Crown Bioscience (CRO), plus Selexis (cell line development). KBI Biopharma is a biologics CDMO providing mammalian and microbial expression, process development, analytical development, and clinical through commercial GMP manufacturing. Crown Bioscience is a separate CRO arm focused on preclinical oncology. This entity spans CDMO and CRO, but the primary CDMO identity is through KBI Biopharma. FDA registered with 4 FEI numbers and 5 inspections (4 NAI, 1 VAI).

KBI Biopharma

Switzerland

KBI Biopharma is a global biologics CDMO (part of JSR Life Sciences) providing mammalian and microbial-based biopharmaceutical development and manufacturing services. Offers cell line development (SUREtechnology Platform powered by Selexis for CHO, PUREplatform for E. coli), process development, analytical development, formulation development, characterization, clinical and commercial GMP manufacturing. FDA registered (FEI 3004638264) with ANALYSIS, API MANUFACTURE, and MANUFACTURE operations. Positioned as a 'next-generation CDMO' with standalone services portal for analytical testing.

Laboratorios Farmaceuticos ROVI S.A. is a major Spanish CDMO and pharmaceutical company, one of the leading European contract manufacturers for high-value-added injectable products. Their CDMO division (ROIS) operates three industrial complexes: two for injectables (Madrid and San Sebastian de los Reyes) and one for oral solid forms and packaging (Alcala de Henares). They also have two facilities in Granada for their own products (bemiparin and enoxaparin). ROVI's Madrid injectables plant is approved by EMA, FDA, and regulators in Korea, Brazil, and Gulf States, with ISO 9001, ISO 14001, and OSHAS certifications. They recently acquired a Bristol-Myers Squibb injectable drug product manufacturing site in Phoenix, Arizona for $250 million, expanding their capacity. ROVI provides end-to-end services from development to final product release, including clinical trials, stability studies, and analytical services. They have collaborated with Roche for manufacturing new medicines in development.

LOTTE BIOLOGICS

South Korea

LOTTE BIOLOGICS is a global biologics CDMO headquartered in South Korea, offering end-to-end development and cGMP manufacturing services for biological Drug Substance. Operates the Syracuse Bio Campus (New York, USA) with 40,000L capacity and the Songdo Bio Campus (Incheon, South Korea) planned for 120,000L by 2027. Also operates a $100M ADC manufacturing facility.

Mabion S.A.

Poland

Mabion S.A. is a Polish end-to-end biologics CDMO offering Drug Substance manufacturing, fill/finish, process development, cell line development and banking, and analytical services. Headquartered in central Poland (1.5 hours from Warsaw airport), they position themselves as a European CDMO partner for pharma and biotech companies. Their capabilities span the full biologics lifecycle from gene to vial.

MabPlex International

China

MabPlex International is a China-headquartered CDMO providing comprehensive biomanufacturing services for the global biopharmaceutical and biotechnology industry. They offer innovative CRO and CMO services for biologics, with facilities in China and the USA (MabPlex USA). They are expanding CDMO services and manufacturing capacity to meet global biologics demand, with multiple manufacturing sites.