Cobra Biologics

Contract manufacturing services for viral vectors.

A predictable yet flexible framework designed to reliably support you wherever you are in your gene therapy development journey.

Secure, cloud-based, real-time platform providing access to sample data, milestones, and documents.

Apollo provides users with a centralized platform to submit sample submission forms, track samples, and exchange documents all in one place.

End-to-end cell therapy contract development and manufacturing services (CDMO) covering preclinical stage through commercial production, including process and analytical development, Good Manufacturing Practices (GMP) manufacturing, and integrated quality control.

Customized cell therapy analytical processes developed and qualified to ensure quality, monitor safety, and measure efficacy throughout your manufacturing process.

Flexible manufacturing platforms designed for cell therapy products.

Custom manufacturing services to swiftly scale up cell production while meeting CGMP guidelines.

High-throughput sequencing methodology providing a broad range of viral contamination detection options for biological products.

A next-generation sequencing assay developed in partnership with PathoQuest for cell bank characterization as an alternative to animal models.

A co-spike approach combining murine leukemia virus (MuLV) and minute virus of mice (MVM) testing into a single run for CHO-cell-derived biopharmaceutical products, reducing starting material utilization and process runs.

Comprehensive viral clearance validation services, study design, process scale-down support, and execution meeting regulatory expectations under GLP at the Cologne, Germany facility.

A specialized co-spike procedure of vesicular stomatitis virus (VSV) and baculovirus (BV) designed to optimize viral clearance study design for insect cell and gene therapy vector manufacturing.

Viral clearance and TSE clearance evaluation studies for biopharmaceuticals.

Custom plasmid production and cloning services designed to support cell and gene therapy research at any scale.

Contract development and manufacturing services for plasmid DNA.

Bacterial endotoxin assays designed to fulfill all pharmacopeia requirements, including qualitative gel-clot assays and quantitative kinetic assays.

Contract testing services for endotoxin and pyrogens.

Software and instrumentation for endotoxin testing data management.

ATP bioluminescence rapid microbial detection platform capable of testing cell-based samples, media, water, and final product sterility.

Concentrator used for expanding the compatibility of Celsis rapid detection for products containing cells, providing release testing results in as little as three days.

Validation services and technical support for Celsis rapid sterility testing systems.

Reagent kit that expands the compatibility of Celsis rapid detection for products containing cells.

Strain typing services for environmental monitoring and root cause analysis.

Comprehensive microbial identification and strain typing services.

G-CSF mobilized leukopak with 5-day stimulation, yielding 1 bag of CD34+ hematopoietic stem and progenitor cells.

Dual mobilization (G-CSF + Plerixafor) leukopak kit with 5-day stimulation, yielding 2 collection bags.

G-CSF mobilized leukopak kit with 5-day stimulation, yielding 2 collection bags of CD34+ hematopoietic stem and progenitor cells.

Plerixafor mobilized leukopak kit with 2-day stimulation, yielding 2 collection bags.

Plerixafor mobilized leukopak kit with 1-day stimulation, yielding 2 collection bags.

Custom format cryopreserved human natural killer cells isolated via positive selection targeting the CD56 marker.

Cryopreserved human natural killer cells isolated via negative selection for a purer population free of NKT contamination.

Human CD8+ cytotoxic T cells isolated from fresh leukopaks via positive immunomagnetic selection and cryopreserved for research and discovery.

Fully integrated CGMP cell bank production, storage, and characterization services supporting products from R&D through commercial manufacturing.

Biosafety, potency, impurity testing, and characterization for biologics.

CGMP-compliant biologics testing lab offering analytical testing, cell line characterization, contamination testing, stability programs, lot release testing, and viral clearance testing services.

Plasmid and viral vector products for cell and gene therapy applications.

Extensive, in-house AAV testing experience with rigorous characterization and biosafety testing to ensure gene therapy safety and efficacy.

An integrated concept-to-commercial service offering spanning monoclonal antibody development, CMC development, clinical manufacturing, and safety testing through a partnership with Wheeler Bio.

Comprehensive lot release testing services for bulk drug substances and clinical and marketed biopharmaceutical products supporting EU, US, and global regulatory requirements.

Contract development and manufacturing solutions for cell and gene therapies.

Take advantage of the nAAVigation platform to bolster your gene therapy manufacturing program with all-important predictability, guidance, and reduced time to clinic.

Analytical characterization services for cell lines.

In vivo, in vitro, and biochemical viral detection assays to ensure viral safety of biological products.

Comprehensive bioassay development, validation, and routine testing services to GMP standards for biological products including mAbs, ADCs, proteins, cell and gene therapies, and vaccines.

Rigorous, cGMP-compliant drug substance and drug product lot release testing for global regulatory markets.

Next generation sequencing assay for viral safety testing of raw materials, cell banks, and bulk harvests.

Genetic characterization service for cell banks, plasmids, and virus lots.

Comprehensive contamination and impurity testing services for biologics.

Cell banking services for mammalian and microbial cell lines.

Premium portfolio of off-the-shelf plasmid products to enhance and streamline gene therapy research and discovery programs.

Accelerate your CAR-T manufacturing program with a therapeutic development process built on quality, with custom assays, regulatory compliance, and robust manufacturing processes.

Broad range in vivo screening assays to detect potential contamination caused by unspecified agents and ensure compliance with current regulatory standards for biologics and viral vaccines.

Manufacturing and production capabilities for mammalian and microbial cell banking, vaccines, viral challenge stocks, and antisera production.

Established adeno-associated viral (AAV) vector production platform designed to streamline and secure clinical or commercial supply with reduced production timelines down to less than eight months.

Characterization services to establish reliable reference standards for biotherapeutic manufacturing and testing.

GMP-ready and GMP plasmids designed for adeno-associated virus production and gene therapy programs.

GMP protein analysis support ranging from method development and phase-appropriate validation to process/cleaning validation, sample analysis, drug substance, finished product, and impurity analysis for recombinant proteins and peptide therapeutics.

A comprehensive program supporting biosimilar development programs from GMP facilities for originator characterization, comparability studies, preclinical studies, and clinical sample analysis through final product lot release.

GMP plasmid DNA manufacturing service for all stages of clinical and commercial supply for viral vector manufacturing and DNA vaccines.

Guaranteed specifications available in AAV1, AAV2, AAV5, AAV6, AAV8, and AAV9 serotypes for research-grade applications.

Confidently accelerate your ex vivo gene therapy manufacturing program with a therapeutic development process built on quality.

Comprehensive genetic stability testing services for prokaryotic and eukaryotic production cell substrates, including restriction endonuclease mapping, Southern and Northern blotting, and qPCR copy number determination.

A holistic approach to host cell protein assay development combining tools from proteomics, bioinformatics, protein synthesis, and immunology to maximize HCP assay performance.

Leverage the Lentivation platform and decades of gene therapy manufacturing experience to overcome challenges with scalability, quality, regulatory compliance, and stability.

With multiple manufacturing options, track record and commitment to quality required to scale up your gene or gene-modified cell therapy program.

Advanced mass spectrometry techniques for comprehensive structural analysis and characterization of biologics.

Our team has the experience and dedication to quality that you need to scale up your adenovirus gene therapy program into a patient-ready product.

Established lentiviral vector production platform designed to streamline and secure clinical or commercial supply with reduced production timelines down to seven months.

Charles River provides flexible and reactive immunization protocols on a wide range of species from SPF rodents to large animals, ranging from research quantity supplies to industrial production.

Tailored viral packaging services for in vitro and large-scale animal studies, supporting clinical and commercial vector needs.

ADCC reporter bioassay, ADCP reporter assay, CDC assay, and microneutralization assay for Palivizumab targeting RSV.

Comprehensive viral inactivation testing and viral clearance study program for medical devices utilizing human or animal tissues and derivatives to ensure safety and regulatory compliance.

In vivo vaccine studies covering short- and long-term challenge studies across multiple species to support regulatory submissions.

Research grade, High Quality (HQ), and GMP off-the-shelf plasmids immediately available, fully documented, and ready-to-use.

Tailored custom GMP virus production capabilities meeting unique project requirements for gene therapy development.

Testing services to identify and quantify process and product-related impurities such as IPTG, E1a, PEI, kanamycin, and host cell proteins.

Compendial assays for the detection of bacterial contaminants to support biologic drug development programs.

The eXpDNA platform expedites fit-for-purpose plasmid production from research to High Quality and GMP grade, supporting all stages of clinical development through commercial supply.

Comprehensive mycoplasma testing services for biopharmaceutical manufacturing and cell cultures, offering both compendial and rapid testing methods compliant with global regulatory standards.

Traditional contract microbiology testing services.

Proliferation assay measuring the potency of human growth factors such as G-CSF and pegG-CSF.

Proliferation assay measuring the potency of human growth factors such as GM-CSF and pegGM-CSF.

Proliferation assay with luminescence readout for Infliximab targeting TNF.

Plasmid DNA manufacturing service for toxicology studies and Phase I-II critical starting materials supporting viral vector and mRNA manufacturing.

Comprehensive bioassay method development, optimization, transfer, and ICH-compliant validation supporting the full lifecycle of biologics, vaccines, and biosimilar potency evaluation.

Proliferation assay measuring the potency of erythropoietin and modified EPO products.

Potency measurement for human growth factors and hormones using classical proliferation assays or HTRF cAMP assays.

IL12/IL23 reporter bioassay for Ustekinumab targeting IL12/IL23p40.

Multi-assay testing panel for Adalimumab targeting TNF, including binding, ADCC, ADCP, proliferation, apoptosis, and NFkB assays.

PD1/PD1L reporter bioassay for Pembrolizumab and Nivolumab targeting PD1/PD1-L.

Proliferation assay for IFNα 2b cytokine products complying with European Pharmacopoeia requirements.

Compendial bioassays on various cytokine products based on the inhibitory activity of cytokines on the cytopathic effect of a virus on a susceptible cell line.

Research-use and GMP-compliant human immune cells to support your advanced therapy.

Cell-based bioassays including ADCC reporter bioassay and CDC luminescence based assay for Cetuximab.

Proliferation assay for IFNβ 1a cytokine products complying with European Pharmacopoeia requirements.

HTRF bioassay with IL-6 readout for Secukinumab targeting IL-17A.

Proliferation assay for IFNβ 1b cytokine products complying with European Pharmacopoeia requirements.

Platform providing tailored support, downscale assistance, process step execution, and results interpretation for viral clearance programs.

Analytical testing for residual DNA and host cell DNA fragments in biological and drug products.

Integration site analysis service designed for genetic characterization of cell banks and gene therapy products.

Caspase 3/apoptosis assay and NFkB reporter for Etanercept targeting TNF.

Custom molecular cloning services to support gene therapy and biopharmaceutical development.

VEGF reporter bioassay and neutralization assay with primary HUVEC cells for Bevacizumab targeting VEGF.

CTLA4 reporter bioassay and ADCC reporter bioassay for Ipilimumab targeting CTLA4.

Comprehensive bioassay services for Rituximab targeting CD20, including epitope binding, ADCC, ADCP, CDC, and apoptosis assays.

Cell-based bioassays including ADCC reporter bioassay and proliferation assay for Trastuzumab.

VEGF reporter bioassay and neutralization assay with primary HUVEC cells for Ranibizumab targeting VEGF.

Monocyte activation testing (MAT) and pyrogenicity testing services.

Assays for the detection and quantification of host cell proteins as part of impurity and CMC testing.

Guarantees product resistance to mycoplasma growth to meet EU and USP requirements.

A high-resolution hybrid mass spectrometer utilizing quadrupole, Orbitrap, and linear ion trap mass analysis features with CID, HCD, and ETD fragmentation modes for biological drug product characterization.

Cell-based assay based on the determination of cyclic AMP (cAMP) release for parathyroid hormone.

Linearized plasmid templates for IVT leveraging an established plug-and-play screening toolbox, platform processing, and in-house testing.

Flexible rapid bacterial endotoxin testing platforms to meet the microbial control needs of a variety of sample throughput and different lab sizes and configurations.

Shelf lentiviral vector packaging plasmids for use in gene therapy and viral vector development.

Endotoxin detection instruments, rapid sterility testing, and microbial identification services.

Plasmid DNA manufacturing service designed for in vitro R&D and preclinical studies.

Production services for Phase I/II vaccines and viral challenge stocks.

A scientific staffing program that provides flexible insourcing and outsourcing options for biologics developers and manufacturers to evaluate and optimize QC testing programs.

Routine testing of the number of viable aerobic microorganisms to optimize downstream sterility testing from manufacturing to distribution.

In vitro production of hybridomas developed and produced in collaboration with a subcontractor, offering standard or customized development services.

Testing for process residues and impurities utilizing HPLC-ELSD, HPLC-CAD, HPLC-MS, and ELISA platforms.

Advanced inoculation and membrane filtration methods in state-of-the-art isolator and cleanroom environments to align products with global sterility guidelines.

Implements PCR to scrutinize test articles for spiroplasma, including insect and plant-cell-derived products.

RG grade packaging plasmid for third generation lenti viral vector production.

Detects mycobacterium in samples and cell-derived vaccine products.

LAL reagents and accessories for bacterial endotoxins testing.

Cartridge technology that reduces sample test time and human touch points using a compendial kinetic chromogenic method.

Fresh leukopaks that play a critical role in the discovery, development, and manufacturing of immune cell therapies.

PBMCs produced by combining lots from different donors, designed for pyrogen presence testing and preclinical antibody testing.

Assesses susceptibility of raw materials and finished products to microbial growth by quantifying bacteria and fungi under aerobic conditions.

Identification services for bacterial and fungal isolates.

Environmental Monitoring Performance Qualification (EMPQ) identification and reporting services designed to help QC professionals navigate cleanroom validation, contamination control, and regulatory compliance.

Rapid, point-of-use handheld spectrophotometer that utilizes USP/BET-compliant disposable cartridges for precise, convenient, and real-time endotoxin testing.

Fully human scFv discovery services utilizing highly diverse antibody phage display libraries engineered for developability.

Customized and expedited programs for rare and orphan disease indications and GMP compliance guidance.

Genotypic microbial identification and strain typing service utilizing comprehensive microbial databases for accurate species-level identification.

Polyclonal antibody production on different species including rabbits, rodents, guinea pigs, and sheep, along with related support services like antigen synthesis, antibody purification, and labeling.

VHH single-domain antibody services and libraries ideal for nanobody discovery, featuring humanized VH3-23 framework or fully natural camelid framework libraries.

Isolated and processed same-day and onsite from freshly collected peripheral blood leukopaks using immunomagnetic cell separation procedures.

PBMCs derived from mobilized apheresis collections with increased CD34+ yields.

X-Ray irradiated human peripheral blood mononuclear cells that cannot proliferate, serving as a safe alternative to gamma rays or mitomycin C treated PBMCs.

CD3+ pan T cells isolated from fresh leukopaks using positive immunomagnetic cell separation techniques, cryopreserved using CryoStor CS10 media.

Fully human, highly diverse antibody phage display libraries built on proprietary bioinformatic analysis of the human immune repertoire for rapid antibody hit identification.

Yeast display antibody discovery service that complements scFv and VHH antibody phage libraries to maximize both binder diversity and affinity.

Comprehensive environmental monitoring programs and services for the pharmaceutical industry, covering air, surface, personnel, water, and utility monitoring to ensure regulatory compliance and product safety.

Differentiated from CD14+ monocytes that are isolated and processed same-day and onsite from freshly collected leukopaks.

Human peripheral blood mononuclear cells isolated onsite and same day from a leukopak collection using Ficoll density gradient centrifugation and immediately cryopreserved.

An excellent source of CD34+ and CD133+ hematopoietic stem and progenitor cells.

Isolated and processed same-day and onsite from freshly collected leukopaks with multiple vial sizes available.

Detects the presence of toxins in medical devices, components, and raw materials.

Transgenic mouse and rat model creation services.

Natural Killer cells isolated and processed same-day and onsite from freshly collected peripheral blood leukopaks.

PBMCs isolated from immune-mediated (autoimmune) disease patients, collected in accordance with an IRB-approved protocol.

Isolated and processed same-day and onsite from freshly collected leukopaks.