BSL-2 CDMOs

AGC (AGC Biologics & AGC Pharma Chemicals)

United States

AGC Biologics is a leading global CDMO providing contract development and manufacturing services for biologics, cell and gene therapies, and advanced modalities. With facilities in Seattle, Copenhagen, Heidelberg, Milan, Chiba, and Yokohama, AGC operates mammalian and microbial expression systems and offers end-to-end services from process development through commercial-scale manufacturing.

BioGeneric Pharma (BGP)

Egypt

BioGeneric Pharma S.A.E (BGP) is an Egyptian international biopharmaceutical company specializing in the development, production, analysis, and marketing of therapeutic recombinant proteins, biosimilars, and vaccines. BGP operates a state-of-the-art biomanufacturing facility in 10th of Ramadan Industrial City, Egypt. The company offers contract manufacturing (CMO) and toll manufacturing services with capabilities spanning biomanufacturing, fill/finish (vials, PFS, cartridges), quality control labs, and mRNA technology (WHO mRNA technology transfer hub partner). Has single-use technology for upstream (25L to 2,000L bioreactors) and downstream processing.

Biological E Limited

India

Biological E Limited is an Indian biopharmaceutical company focused on vaccine development and manufacturing, with production capacity of up to 1 billion vaccines annually. They offer contract manufacturing for vaccines and biologics, with FDA-registered facilities performing analysis, API manufacture, labeling, manufacturing, and packing. Partners include Bavarian Nordic for chikungunya vaccine manufacturing.

Boehringer Ingelheim Biopharmaceuticals GmbH (BioXcellence)

Germany

Boehringer Ingelheim BioXcellence is the contract biopharmaceutical manufacturing arm of Boehringer Ingelheim, one of the world's largest pharmaceutical companies. BioXcellence offers end-to-end biologics CDMO services including mammalian cell culture, microbial fermentation, viral vector production, and aseptic fill/finish with extensive FDA, EMA, and PMDA regulatory approvals across multiple global facilities.

Boston Institute of Biotechnology (BIB)

United States

Boston Institute of Biotechnology (BIB) is a US-based full-service CDMO offering cGMP and non-GMP mammalian, microbial, gene therapy, and cell therapy services. The company features the world's first ultra-large bioreactor with 30,000L working volume capacity and provides end-to-end services from cell line development through commercial-scale cGMP manufacturing.

Canton Biologics Co., Ltd.

China

Canton Biologics Co., Ltd. is a biologics CDMO founded by Chinese returnee scientists at Guangzhou International Biological Island. The company provides integrated R&D and manufacturing services for biologics including CMC development, GMP manufacturing up to 2000L, analytical development, and aseptic fill/finish with GMP certifications from China, US, Japan, and Europe.

HALIX

Netherlands

HALIX is a biologics CDMO based in Leiden, Netherlands, specializing in end-to-end development and GMP manufacturing of viral vectors, vaccines, and recombinant proteins. The company operates a 6,700 square meter cGMP facility at the Leiden Bio Science Park with 10 clean rooms and 7 bioreactors. HALIX successfully manufactured the AstraZeneca COVID-19 vaccine at commercial scale and serves over 75 customers with a 90% retention rate.

HIPRA Biotech Services

Spain

HIPRA Biotech Services is the CDMO division of HIPRA, a Spanish biopharmaceutical company with over 50 years of experience in vaccine research, production, and commercialization. The CDMO unit offers comprehensive biologics contract development and manufacturing services across mammalian, avian, and insect cell culture, microbial fermentation (E. coli, yeast), and aseptic fill-and-finish. HIPRA has experience with over 300 biological entities and demonstrated rapid development capability during COVID-19 vaccine production.

IDT Biologika

Germany

IDT Biologika is a leading global biologics CDMO headquartered in Germany, specializing in end-to-end development and manufacture of viral vaccines, gene and immune therapeutics, and aseptic fill-finish of sterile injectables. Founded in 1921 with over a century of experience in vaccines, the company operates BSL-2 facilities and has completed over 200 development, clinical, and commercial projects. IDT Biologika is a subsidiary of SK bioscience.

Indian Immunologicals Ltd

India

Indian Immunologicals Ltd (IIL) is an Indian market leader in veterinary and human biologicals, manufacturing over 150 registered products. The company offers contract manufacturing services, producing safe and efficacious bio-pharmaceuticals for several leading pharma and vaccine companies in India and internationally. IIL exports animal and human vaccines to more than 50 countries and has sold billions of doses of vaccines.

Intravacc

Netherlands

Intravacc is a Netherlands-based vaccine CDMO founded in 2013 with ~200 employees, specializing in vaccine development from discovery through Phase II clinical trials. The company provides cGMP manufacturing of bacterial, viral, conjugate, and oncological vaccines using mammalian and microbial fermentation systems (up to 200L single-use bioreactors), along with comprehensive analytical services and proprietary vaccine platforms including Outer Membrane Vesicle (OMV) technology.

Lonza

Switzerland

Lonza is a pioneer and world leader in the CDMO industry, founded in Switzerland in 1897. The company provides integrated development and manufacturing services across biologics, small molecules, cell and gene therapy, mRNA, and bioconjugates (ADCs/HPAPIs). With over 20,000 employees across five continents, Lonza serves the global pharmaceutical, biotech, and nutrition industries with end-to-end capabilities from early development to commercial-scale manufacturing.

OFD Life Sciences

India

OFD Life Sciences is a division of Oregon Freeze Dry, one of the largest and most experienced lyophilization companies, with over 60 years of freeze-drying expertise. The company provides comprehensive lyophilization services for biopharma, medtech, and consumer health sectors, from development through commercialization. Its proprietary LyoVantage platform supports cycle development and clinical trial and commercial-scale lyophilization.

Porton Advanced Solutions

China

Porton Advanced Solutions is a China-based CRO and CDMO specializing in Advanced Therapy Medicinal Products (ATMPs). They provide end-to-end services from cell banking, process and analytical method development, GMP production, to fill and finish. Their platforms include lentivirus (for CAR-T, TCR-T, CAR-NK), plasmid DNA (supercoiled, linear, LcDNA), mRNA and LNP encapsulation, AAV, and bacterial vectors. They have achieved 18 IND approvals across NMPA (13), FDA (4), and MedSafe (1), with 300+ GMP batches and 200+ GMP IITs batches produced.

ProBioGen AG

Germany

ProBioGen AG is a fully integrated CDMO headquartered in Berlin, Germany, specializing in the development and GMP manufacturing of biopharmaceuticals, viral vectors, and vaccines. The company offers cell line development, process development, GMP manufacturing up to 1000L bioreactors, and comprehensive analytical services. ProBioGen leverages proprietary technologies including GlymaxX (ADCC enhancement), DirectedLuck (transposase system), and CHO.RiGHT production systems.

SK bioscience

South Korea

SK bioscience is a South Korean vaccine-focused biopharmaceutical company that also operates as a CDMO. Listed on KOSPI (302440), they develop proprietary vaccines (influenza, varicella, COVID-19, pneumococcal, HPV, RSV) and provide CDMO/CMO services for vaccine manufacturing. They acquired a controlling stake in German CDMO IDT Biologika for approximately $244M, gaining manufacturing sites in Dessau (Germany) and Rockville (Maryland, USA). SK bioscience collaborates with the Bill & Melinda Gates Foundation, CEPI, and international vaccine initiatives. They have WHO prequalified products.

Thermo Fisher Scientific Inc.

China

One of the world's largest pharmaceutical CDMOs through its Patheon pharma services division. Provides end-to-end pharmaceutical development and manufacturing services for both small molecules and biologics, from API manufacturing through drug product, sterile fill/finish, packaging, and commercial supply. Operates 31+ FDA-registered facilities globally. 158 FDA inspections on record (52 NAI, 104 VAI, 2 OAI). Also provides cell therapy manufacturing solutions (CTS Rotea cell processing system), laboratory informatics, bioprocessing equipment, and reagents. 4 FDA-approved drug products. Revenue >$40B (full company).

Waisman Biomanufacturing

United States

Waisman Biomanufacturing is an academic CDMO based at the Waisman Center at the University of Wisconsin-Madison, specializing in advancing novel biologics and vaccines into early clinical trials. The facility manufactures plasmid DNA, recombinant proteins, cell therapeutics, extracellular vesicle/secretome products, live biotherapeutic products, and viral vectors under cGMP conditions.

WuXi Biologics

China

WuXi Biologics is a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) for biologics, with over 12,000 employees across the US, Ireland, Germany, China, and Singapore. The company provides end-to-end solutions from discovery through commercial manufacturing for biologics including monoclonal antibodies, bispecifics, ADCs, vaccines, and mRNA products using both mammalian and microbial expression systems.

Yposkesi (an SK pharmteco company)

France

Yposkesi, an SK pharmteco company, is one of Europe's largest Contract Development and Manufacturing Organizations (CDMO) for gene therapy viral vector manufacturing. Based near Paris (Evry-Courcouronnes), the company provides end-to-end gene therapy CDMO services including process development, cGMP manufacturing, analytical testing, and regulatory support for AAV, lentivirus, and other viral vectors.

Akron Biotech

United States

Akron Biotech is a leading contract manufacturing organization (CMO/CDMO) providing cGMP-compliant solutions for cell and gene therapy. The company manufactures cytokines, growth factors, media, buffers, and transfection/transduction reagents, and recently expanded to a second 60,000 sq ft biologics manufacturing facility in Sarasota, Florida, to support growing demand for ancillary materials in cell and gene therapy.

Andelyn Biosciences

United States

Andelyn Biosciences is a gene therapy and viral vector CDMO with deep expertise in the development and production of viral vectors. The company has produced 450+ cGMP clinical batches, supported 75+ INDs, and operates 225,000+ sq ft of facility space. Andelyn offers viral vector manufacturing, plasmid manufacturing, process development, and laboratory services, with a proprietary AAV Curator platform.

Anemocyte S.r.l.

Italy

Anemocyte is an Italian biotech manufacturing organization (self-described as a BMO) specializing in plasmid DNA, mRNA, and viral vector development and manufacturing for the cell and gene therapy sector. They provide GMP-grade contract manufacturing services for advanced therapies.

Batavia Biosciences

Netherlands

Batavia Biosciences is a Netherlands-based CDMO dedicated to viral vector and vaccine development. They provide process development, GMP manufacturing through their Batavia Biomanufacturing division, and offer proprietary technologies including HIP-Vax, SCOUT, SATIRN, STEP, and SIDUS platforms. They support clients from bench to bedside in viral vectors, viral vaccines, recombinant proteins, and oncolytic viruses.

Biologics Manufacturing Centre (BMC) Inc.

Canada

Biologics Manufacturing Centre (BMC) Inc. is a Canadian end-to-end GMP biomanufacturing facility with a public good mandate, established to secure domestic biologics supply. Licensed by Health Canada (DEL 3-002766-A and 3-002818-A) to manufacture and test biological products and vaccines. The facility is BSL-2 accredited and supports orphan drug development for rare and genetic diseases. Subsidiary of the National Research Council Canada.

CELLforCURE by SEQENS

France

CELLforCURE by SEQENS is a leading EMA-authorized CDMO dedicated to the development and commercial manufacturing of cell and gene therapies (ATMPs). Located near Paris, the company operates a 10,000 m2 site with 3,000 m2 of GMP area featuring 7 independent GMP manufacturing lines, 48 cleanrooms, and an 800 m2 dedicated QC lab. With over 15 years of track record, CELLforCURE has completed 25+ tech transfers, manufactured 600+ autologous CAR-T commercial doses and 10,000+ allogeneic CAR-T clinical vials.

Center for Breakthrough Medicines (CBM)

United States

Center for Breakthrough Medicines (CBM) is a cell and gene therapy CDMO based in King of Prussia, Pennsylvania, operating at The Discovery Labs campus. CBM offers comprehensive services including plasmid manufacturing (Precision Plasmids), viral vector manufacturing (Genesis Vector Manufacturing Solutions), cell therapy manufacturing, and analytical testing (Analytical Accelerator for AAV testing). SK Pharmteco acquired controlling interest in CBM, and the company has capacity to manufacture therapies for 10,000+ patients.

Centre c3i

Canada

C3i Center Inc is the first CDMO in Canada to receive approval for a Drug Establishment License to commercially produce cell therapy drug products. Based in Montreal, the company provides tailored cell and gene therapy CDMO services from development through commercial manufacturing.

CoJourney Inc

China

CoJourney Inc is a CDMO partner specializing in cGMP manufacturing for gene therapies, featuring its proprietary Zero Chrom plasmid manufacturing platform that eliminates chromatography for higher purity and lower cost. The company provides plasmid DNA, viral vector (AAV, lentivirus, adenovirus), sgRNA GMP manufacturing, and exosome manufacturing services, having served over 100 customers and delivered more than 400 batches with a proven IND approval track record with FDA and CDE.

OBiO Tech (OBiO Technology)

China

OBiO Technology (Shanghai) Corp., Ltd (688238.SH) is a China-based biotechnology company and CRO/CDMO group focusing on cell and gene therapy. The company provides end-to-end offerings including process development, analytical method development, IND-enabling CMC, and clinical and commercial contract manufacturing of viral vectors, oncolytic viruses, and cell therapy products. OBiO operates a 10,000-square-meter GMP campus (Intelli-M PINE Site) with 29 GMP production lines.

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.

Oxford Biomedica (OXB)

United Kingdom

Oxford Biomedica (OXB) is a global, quality- and innovation-led CDMO specializing in viral vector development and manufacturing for cell and gene therapy. With 25+ years of experience, OXB is the first and currently only FDA-approved CDMO for commercial production of lentiviral vectors for CAR-T therapy. The company operates GMP suites across three countries with extensive end-to-end capabilities in lentivirus, AAV, and adenovirus vectors.

Pharmicell Chemical

South Korea

Pharmicell Co., Ltd. is a South Korean biopharmaceutical company operating both chemical (API) and biologics (stem cell therapy) divisions, with CDMO services. The Chemical Business Unit in Ulsan (Onsan) manufactures oligonucleosides, pharmaceutical PEGs, and industrial advanced materials. The Bio division developed the world's first approved stem cell therapy (Hearticellgram AMI for cardiac repair) and provides CDMO services for advanced cell therapies with GMP facilities including Grade B/C clean rooms, virus testing labs, and microorganism testing labs. The company holds ISO 9001, ISO 14001 certifications and reported record revenue of 114 billion KRW in 2025. Pharmicell is expanding CDMO operations for regenerative medicine with capability to handle 7 cell types.

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).

Scientific Protein Laboratories (SPL)

United States

Scientific Protein Laboratories (SPL) is a CDMO specializing in cGMP biopharmaceutical manufacturing of APIs from biological sources, with over 30 years of experience. Core products include heparin derivatives (Heparin Sodium USP) and pancreatic enzymes (Pancreatin USP, Pancrelipase USP). The company also provides custom development services including fermentation, natural product extractions, and recovery/purification of therapeutic proteins from preclinical through commercial scale.

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.

SCTbio

Czechia

SCTbio is a Czech CDMO specializing in cell and gene therapy (ATMP) manufacturing, spun out from SOTIO. The company provides cGMP production of cell-based therapies and retroviral/lentiviral vectors from its 2,000 sqm facility in Prague, Czech Republic. SCTbio has specialized expertise in dendritic cell therapeutics, CAR-T, and viral vector production, supported by a global network of 150 apheresis collection centers.

Takara Bio

Japan

Takara Bio (a Takara Holdings company) is a Japanese biotechnology company with a significant CDMO business for cell and gene therapy products. They operate the Center for Gene and Cell Processing (CGCP) at their headquarters in Shiga, Japan, which they have expanded to accommodate a variety of advanced therapy modalities. Their CDMO services cover comprehensive cellular and gene therapy product manufacturing and quality testing. Takara Bio also supplies reagents and instruments (research tools business) but the CDMO division is a distinct contract manufacturing operation. They have GMP-grade manufacturing capabilities in both Japan and Goteborg, Sweden (Takara Bio Europe AB).

Theragent Inc

United States

US-based comprehensive CDMO focused on advancing next-generation cell- and tissue-based therapies, from R&D to cGMP manufacturing. Located in Arcadia, California. Has partnerships with CellVax Therapeutics (first manufacturing collaboration, Phase 2 trial for FK-PC101), Pluristyx (iPSC-derived therapies), and Insight68 (Pharma 4.0 AI software). Works with iPSC, NK cells, T cells, and CAR-T for allogeneic and autologous therapies. Expanding leadership team with experienced biopharma executives.

Vector BioMed

United States

Vector BioMed is a U.S.-based public benefit corporation and CDMO specializing in lentiviral vector design and manufacturing for cell and gene therapies. Launched following $15M in funding, the company provides essential lentiviral vector capabilities using their proprietary LENTIVERSE platform. They produce high-titer (>10^9 TU/mL) lentiviral vectors using a serum-free, chemically-defined process. Key differentiators include algorithm-optimized vector design, rapid turnaround (months from onboarding to GMP batch release), modular pre-validated systems to reduce costs and avoid royalty-based constraints, and a focus on making advanced therapies accessible in lower-resource settings. They partner with CIRM (California Institute for Regenerative Medicine) on lentiviral vector manufacture.

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.

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.

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.

CHA Biotech is a South Korean biotechnology company within the CHA Hospital Group, established in 2002 with over 20 years of expertise in stem cell research and cell and gene therapy. The company operates a global CGT CDMO network through its US subsidiary Matica BioLabs, with GMP facilities in Korea (CHA Bundang Medical Center, Pangyo Techno Valley) and the US (Texas). CHA Biotech offers viral vector production (500L capacity for clinical trials) and has secured multiple CDMO contracts for CAR-T and organoid therapies.

Polymun Scientific Immunbiologische Forschung GmbH is an Austrian specialist CDMO in biopharmaceuticals and liposomal/lipid nanoparticle (LNP) formulations. Offers contract development and manufacturing from gene to clinical grade material for innovator and biosimilar products. Unique expertise in liposomal drug formulations that protect, transport, and release drugs at target sites. Also maintains R&D projects including liposomal superoxide dismutase, recombinant porcine trypsin, and HIV antibodies/antigens. FDA registered for analysis, API manufacture, and manufacture.

ReciBioPharm (now Recipharm Advanced Bio) is the advanced therapies division of Recipharm, a global CDMO devoted to process development and GMP manufacturing for advanced therapeutics including xRNA therapies, viral vectors, microbial/live biotherapeutic products, and recombinant proteins. They offer end-to-end services from preclinical development to commercial manufacturing, with operations on two continents. They have partnerships with the University of Oxford, NewBiologix (AAV cell lines), LenioBio, and Hongene Biotech.

uBriGene Biosciences Inc is the same entity as uBriGene (duplicate entry, different ID). This is the China-headquartered entity of the same global CRDMO providing one-stop viral vector-based CDMO services for research and clinical applications. Series C+ funding of 150M CNY (~$20M USD). Same website, same capabilities. See uBriGene entry (ID 10a6a05c) for full details.