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GenWay Biotech Incorporated

San Diego, California, US

Since 1998, we have provided the research community with proteomic solutions and applications by offering a comprehensive catalog of products and services. To date, GenWay scientists have produced thousands of proteins and antibodies in our San Diego facility.

Our company strives to provide the best value of reagents to the research community. We stand by the data provided in our product datasheets, and we will offer full refunds if products do not meet the established specifications.

As a protein and antibody solutions provider, GenWay has a multi-functional technology platform specialized in using genes, proteins, antibodies, and their applications in cells, tissues and animal models, for functional genomics and proteomics. GenWay’s core competencies enable the Company to carry out bioinformatic analyses of protein targets, produce high-quality protein antigens and ligands, and develop domain-specific IgY... Show more »

Since 1998, we have provided the research community with proteomic solutions and applications by offering a comprehensive catalog of products and services. To date, GenWay scientists have produced thousands of proteins and antibodies in our San Diego facility.

Our company strives to provide the best value of reagents to the research community. We stand by the data provided in our product datasheets, and we will offer full refunds if products do not meet the established specifications.

As a protein and antibody solutions provider, GenWay has a multi-functional technology platform specialized in using genes, proteins, antibodies, and their applications in cells, tissues and animal models, for functional genomics and proteomics. GenWay’s core competencies enable the Company to carry out bioinformatic analyses of protein targets, produce high-quality protein antigens and ligands, and develop domain-specific IgY antibodies for immunoaffinity capture, partitioning, detection and analyses. The Company can also provide downstream proteomic analyses, target validation, and diagnostic product development.

The laboratory and manufacturing space is 6,000 sq. ft. equipped with all appropriate safety equipment.

The laboratory area is adjacent to manufacturing and is designed to support several departments including: analytical, molecular biology, virology, cell biology, process development and viral clearance. State of the art equipment specific to each discipline is found in each of the laboratories. Custom protocols/methods are routinely developed on a project basis in collaboration with the customer. Process development uses equivalent upstream and downstream equipment platforms enabling highly efficient technology transfer to production operations that are substantially in compliance with GMP standards.

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GenWay Biotech Incorporated has not listed any services.

Target Gene Expression Analysis
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Medical Device Clinical Trials
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In vitro Diagnostic/Companion Diagnostic Testing
In Vitro Diagnostic Testing
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In vitro Diagnostic Development
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GenWay’s Clinical Laboratory Services offer reliable pre-clinical study and clinical trial testing to support companion diagnostic development, a PMA submission, or a 510(k) submission. GenWay works with your clinical, scientific, and regulatory personnel to define study objectives and specifications. Based on your needs, we... Show more »

GenWay’s Clinical Laboratory Services offer reliable pre-clinical study and clinical trial testing to support companion diagnostic development, a PMA submission, or a 510(k) submission. GenWay works with your clinical, scientific, and regulatory personnel to define study objectives and specifications. Based on your needs, we provide a project budget and a timeline with including milestone deliverables. At each milestone scheduled, we provide a progress report based on your specifications.

Custom Service Experts

  • GenWay has extensive experience producing antibodies, protein standards, and assays for clinical applications;
  • GenWay has the assay development knowledge to take new biomarkers, develop, optimize and validate a kit in a clinical setting to meet any need that are currently unavailable through GenWay’s catalog or via other organizations.
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Elisa Kit Development
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GenWay offers a full line of custom ELISA Assay services including Assay Development, Assay Validation, Clinical Trial Testing, and Clinical (CLIA) Testing. We leverage our expertise in development and validation of antibodies and antigens to reduce development time and improve assay results.

Our ELISA Development services... Show more »

GenWay offers a full line of custom ELISA Assay services including Assay Development, Assay Validation, Clinical Trial Testing, and Clinical (CLIA) Testing. We leverage our expertise in development and validation of antibodies and antigens to reduce development time and improve assay results.

Our ELISA Development services include:

  • Meet regulatory requirements, as required by the customer
  • Procure the analyte through GenWay development or supplied by the customer
  • Procure the antibody through GenWay development or supplied by the customer
  • Procure appropriate Control Samples; provide recommendations on appropriate Control Samples, if requested
  • Determine the dilution factor for antibody and analyte and perform antibody conjugation labeling
  • Determine the dilution factor for Samples, Standards, and Controls
  • Determine incubation times and temperatures
  • Determine acceptance criteria based on data analysis
  • Perform Sensitivity analysis
  • Perform Precision analysis
  • Determine Lower Limits of Detection and Quantitation
  • Determine Upper Limits of Detection and Quantitation
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Custom Monoclonal Antibody (mAb) Production
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IgY Monoclonal Antibody Development

GenWay Biotech has many years of experience developing scFv chicken IgY antibodies. Chicken IgY scFv fragments combine the advantages of chicken IgY polyclonal antibodies, monoclonal antibodies, and scFv recombinant antibodies.
Recombinant scFv single-chain antibodies are gaining... Show more »

IgY Monoclonal Antibody Development

GenWay Biotech has many years of experience developing scFv chicken IgY antibodies. Chicken IgY scFv fragments combine the advantages of chicken IgY polyclonal antibodies, monoclonal antibodies, and scFv recombinant antibodies.
Recombinant scFv single-chain antibodies are gaining popularity in the therapeutic and diagnostic industries. Advantages of scFv antibodies include:

  • Higher specificity
  • Alterable affinity after clone selection by random mutagenesis
  • Highly scalable manufacturing - fragments are expressed in bacteria and purified using regular protein tags
  • Lower cross-reactivity due to the absence of invariable regions
  • Consistency and reproducibility

Our general process for scFV antibody development is as follows:

Antigen is prepared using bioinformatics analysis and our proprietary fusion domains and vectors. Chickens are immunized and polyclonal antibodies are analyzed to indicate immune response of the host. Once the chicken with the best immune response is identified, its B-cells are isolated, and total RNA is prepared. Total RNA is later used for cDNA library generation and subsequent phage library preparation. Positive clones are selected and scFv fragments are expressed in E. coli.

Process Summary

  • Immunization and Purification of Polyclonal IgY
  • IgY Fragment coding cDNA preparation
  • Phage library construction
  • Phage library screening
  • Antibody expression in E. coli
  • Antibody characterization

Monoclonal IgY Antibody

GenWay Biotech has over 15 years of experience in development and production of monoclonal antibodies. Our experienced scientific team will work to design a protocol that will meet your needs for research, product development, or Clinical or IVD use.

Standard Hybridoma Development Description

  1. Immunization
    • Purchase of 5 Balb/C mice or 3 Fisher rats
    • Pre-immunization test bleed for negative baseline
    • Immunizations and test bleeds
    • Antibody titer of test bleeds by ELISA
    • One or two mice or rats with the best titers are selected for fusion
    • Pre-spleen collection boost before fusing
    • Typically 70 – 90 days depending on antigen and immune response
  2. Fusion and Selection
    • Lymphocytes from 2 mice or one rat are pooled and fused.
    • Fused cells are grown on HAT selective single-step cloning media.
    • Clones are transferred to 96-well plates and expanded.
    • 10 - 14 days
  3. Screening and Expansion of Hybridoma Clones
    • Primary screening of hybridoma tissue culture supernatants by indirect ELISA.
    • Positive clones are further tested by ELISA.
    • Positive clones are isotyped and subcloned to identify stable expressing clones.
    • Further evaluation by the client if needed (ship supertantant to client).
    • Report to client
    • 14 - 21 Days
  4. Subcloning and Cryopreservation
    • Selection of 1 to 5 clones in conjunction with client.
    • Cryopreservation of at least 5 vials per selected clone.
    • Storage of vials for 3 months at no charge.
    • Long term storage available (optional).
    • Report to client
    • 14 - 21 days
  5. Antibody Production and Purification (Optional)
    • GenWay offers antibody production and purification services to meet the needs of research, diagnostic development, or for use in FDA or CE medical devices
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Custom Polyclonal Antibody Production
Price on request

Polyclonal IgY Antibody Development

GenWay is one of the most experienced IgY antibody companies in the world, providing complete antibody production services from gene sequences to antibody purification. GenWay’s antibody production service is a one-stop full service: Understanding our client’s specific needs, producing and... Show more »

Polyclonal IgY Antibody Development

GenWay is one of the most experienced IgY antibody companies in the world, providing complete antibody production services from gene sequences to antibody purification. GenWay’s antibody production service is a one-stop full service: Understanding our client’s specific needs, producing and delivering the products according to schedule, and providing technical support post-delivery. We respect our clients’ confidential information, and guarantee that all intellectual property remains with the client.

Here is our standard protocol for IgY custom antibody development:

Overview
Animal White Leghorn Chicken
Immunogen Typical proteins and conjugated peptides
Adjuvant Complete Freund’s Adjuvant (CFA) initially. Incomplete Freund’s Adjuvant (IFA) for all subsequent injections
Schedule
Week: 1 Domain selection through interactions with client
Week: 2-3 Expression vector and antigen preparation
Week: 4-11 Immunization and antibody isolation
Week: 12-13 Antigen affinity-purification and QC validation
Week: 14 Datasheet preparation and product delivery

Notes

Chickens generally lay 15-20 eggs per month
Each yolk (about 15 ml per egg) contains about 50-100 mg Total IgY antibody.

Polyclonal IgG Antibody Development

GenWay has more than 15 years of rabbit polyclonal IgG production experience providing complete antibody production services from gene sequences to antibody purification. GenWay’s antibody production service is a one-stop full service: Understanding our client’s specific needs, producing and delivering the products according to schedule, and providing technical support post-delivery. We respect our clients’ confidential information, and guarantee that all intellectual property remains with the client.

There are a variety of protocols and schedules that can be used for antibody production. Each protocol is designed to meet the timeline, budget, quality, and specifications of the client.

Here is our standard protocol for IgG custom antibody development:

Overview
Animal New Zealand White Rabbits
Immunogen Typical proteins and conjugated peptides
Adjuvant Complete Freund’s Adjuvant (CFA) initially. Incomplete Freund’s Adjuvant (IFA) for all subsequent injections
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Protein Expression in Yeast
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GenWay’s yeast expression platform provides a flexible, controllable, and effective solution for protein expression needs. GenWay’s various yeast expression platforms have been well characterized and are validated to perform many post-translational modifications. GenWay offers an initial assessment of your project and makes... Show more »

GenWay’s yeast expression platform provides a flexible, controllable, and effective solution for protein expression needs. GenWay’s various yeast expression platforms have been well characterized and are validated to perform many post-translational modifications. GenWay offers an initial assessment of your project and makes recommendations regarding expression platforms with appropriate scalability, yield, and functionality. Our approach includes bioinformatics analysis, domain selection, vector design, tag selection, sequence confirmation, cell transfection, cell amplification, purification by tag selection, yield optimization, scale up processing, and protein characterization.

The following is our Yeast protein expression development template:

Order Process Details
Step 1 Bioinformatic analysis, domain selection and vector design GenWay conducts bioinformatic analysis on target(s) and recommends an expression strategy to each client. Sequence verified cDNAs are provided by the client, supplied by GenWay, or are purchased from available commercial sources.
Step 2 Prepare subcloning plasmid and construct expression vectors Project design includes GenWay’s vector system with the most appropriate strategy to construct vectors. If certain specific vectors are requirgb(170,0,0), then custom vectors will be included in the project design.
Step 3 Target sequence analysis and confirmation Conduct DNA sequencing and analysis to confirm correct coding and flanking sequence.
Step 4 Cell transformation and expression clone preparation GenWay will utilize proprietary expression cell lines and prepare expression cell clone. If specific cell lines (e.g. mutants) are needed for accommodating the need for recombinant protein expression and selection, GenWay’s team will discuss with client to make specific arrangements for the project.
Step 5 Protein production and purification Express protein in a small scale culture. Fermentation broth or cell lysate (prepargb(170,0,0) by using microfluidizer) will be collected for filtration and concentration. Expressed protein will be further isolated and purified according the protocol provided by client or developed by GenWay. If the protein is not soluble, processes of solubilization and refolding will be initiated.
Step 6 Quality control test Conduct SDS-PAGE analysis and generate QC report.
Step 7 Scale-up production and quality control test Produce and QC target proteins at a large scale according to client requirements.
Step 8 Characterization of target protein (including functional studies) 1. Determine purity in conjunction with client specifications. 2. Employ a functional assay method provided by client or to be specifically developed. 3. Utilize immunoassays such as western blot analysis, ELISA, etc, after antibodies are produced or provided.

Each protein has its unique biochemical feature in the expression process. GenWay's team will work with the client to develop the best strategy and use the most cost-effective process.

Purification Methods

  • Affinity Chromatography
    • Anti-Flag
    • Glutathione Sepharose
    • Heparin Sepharose
    • Ni-NTA
    • Protein A
    • Protein G
    • Streptavidin Sepharose
    • Talon resin
  • Ion Exchange Chromatography
    • ANX
    • CM Sepharose
    • DEAE Sepharose
    • Mono-Q
    • Q Sepharose Fast Flow
    • Q Sepharose XL
    • Resource Q
    • SP Sepharose
  • Hydrophobic Interaction Chromatography
    • (CH2)n Sepharose
    • Phenyl Sepharose
    • Size Exclusion Chromatography
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Protein Expression in Mammalian Cells
Mammalian cell based recombinant protein production
Price on request

GenWay mammalian expression systems generate high-yields of mammalian proteins. These expression systems are often suggested for proteins requiring mammalian post-translational modifications. GenWay has a great amount of experience producing monoclonal antibodies or recombinant proteins from a wide range of cell types including... Show more »

GenWay mammalian expression systems generate high-yields of mammalian proteins. These expression systems are often suggested for proteins requiring mammalian post-translational modifications. GenWay has a great amount of experience producing monoclonal antibodies or recombinant proteins from a wide range of cell types including CHO, hybridomas, various mouse myeloma, and human cell lines. GenWay performs a comprehensive analysis of your project in order to identify the best expression platforms with appropriate scalability, yield, and functionality. Our service includes bioinformatics analysis, domain selection, vector design, tag selection, sequence confirmation, cell transfection, cell amplification, purification by tag selection, yield optimization, scale up processing, and protein characterization.

The following is our mammalian protein expression development template:

Order Process Details
Step 1 Bioinformatic analysis, domain selection and vector design GenWay conducts bioinformatic analysis on target(s) and recommends an expression strategy to each client. Sequence verified cDNAs are provided by the client, supplied by GenWay, or are purchased from available commercial sources.
Step 2 Construction of expression vectors The target sequence will be cloned into GenWay’s vector system. Based on the specific target protein, the sequence can be inserted into an expression cassette for a secreted or non-secreted protein. GenWay will conduct DNA sequencing and analysis to confirm correct coding and flanking sequences.
Step 3 Cell transfection, selection, and cloning of target-expressing cells The protein can be produced by transient burst or stable cell line expression depending on the client’s specific needs. The expression of the target protein will be confirmed by SDS page or Western blot using an anti-tag antibody or client-provided antibody against the target protein.
Step 4 Protein production and purification GenWay will express the protein in a scale of up to 4x T-75 culture flasks or equivalent. The protein will be purified using a tag-assisted affinity column or other chromatographic methods. Protein samples may be provided to clients if the protein function needs to be confirmed.
Step 5 Scale-up production and quality control test GenWay will produce the target protein(s) at large scale. The scale of production depends on the level of protein expression, the yield of purification, and the requirements of the client.
Step 6 Characterization of target protein (including functional studies) 1. Determine purity in conjunction with client specifications. 2. Employ a functional assay method provided by client or to be specifically developed. 3. Utilize immunoassays such as western blot analysis, ELISA, etc, after antibodies are produced or provided.

Each protein has its unique biochemical feature in the expression process. GenWay's team will work with the client to develop the best strategy and use the most cost-effective process.

Purification Methods

  • Affinity Chromatography
    • Anti-Flag
    • Glutathione Sepharose
    • Heparin Sepharose
    • Ni-NTA
    • Protein A
    • Protein G
    • Streptavidin Sepharose
    • Talon resin
  • Ion Exchange Chromatography
    • ANX
    • CM Sepharose
    • DEAE Sepharose
    • Mono-Q
    • Q Sepharose Fast Flow
    • Q Sepharose XL
    • Resource Q
    • SP Sepharose
  • Hydrophobic Interaction Chromatography
    • (CH2)n Sepharose
    • Phenyl Sepharose
    • Size Exclusion Chromatography
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Bacterial Protein Expression
Price on request

GenWay recombinant protein production in E. coli provides services for antigen production, ligand preparation, and proteins for binding assays, cell based assays, enzymatic assays, vaccine development and therapeutics. Our proprietary platforms can produce functional recombinant proteins, domain specific fragments, fusion... Show more »

GenWay recombinant protein production in E. coli provides services for antigen production, ligand preparation, and proteins for binding assays, cell based assays, enzymatic assays, vaccine development and therapeutics. Our proprietary platforms can produce functional recombinant proteins, domain specific fragments, fusion proteins, and protein complexes. We understand the need for active proteins, free of impurities, to produce clean reproducible results.

Order Process Details
Step 1 Bioinformatic analysis, domain selection and vector design GenWay conducts bioinformatic analysis on target(s) and recommends an expression strategy to each client. Sequence verified cDNAs are provided by the client, supplied by GenWay, or are purchased from available commercial sources.
Step 2 Prepare subcloning plasmid and construct expression vectors Using GenWay's vector system with the most appropriate strategy to construct vectors.
Step 3 Target sequence analysis and confirmation Conduct DNA sequencing and analysis to confirm correct coding and flanking sequence.
Step 4 Cell transformation and expression clone preparation Use GenWay’s proprietary expression cell lines and prepare expression cell clone.
Step 5 Protein production and purification Express protein in a small scale culture, collect and lyse cells, isolate and purify protein. If the protein is not soluble, then the processes of solubilization and refolding will be initiated.
Step 6 Quality control test Conduct SDS-PAGE analysis and generate QC report.
Step 7 Scale-up production and quality control test Produce and purify target proteins at a large scale.
Step 8 Characterization of target protein (including functional studies) 1. Determine purity in conjunction with client specifications. 2. Employ a functional assay method provided by client or to be specifically developed. 3. Utilize immunoassays such as western blot analysis, ELISA, etc, after antibodies are produced or provided.

Each protein has its unique biochemical feature in the expression process. GenWay's team will work with the client to develop the best strategy and use the most cost-effective process.

Purification Methods

  • Affinity Chromatography
    • Anti-Flag
    • Glutathione Sepharose
    • Heparin Sepharose
    • Ni-NTA
    • Protein A
    • Protein G
    • Streptavidin Sepharose
    • Talon resin
  • Ion Exchange Chromatography
    • ANX
    • CM Sepharose
    • DEAE Sepharose
    • Mono-Q
    • Q Sepharose Fast Flow
    • Q Sepharose XL
    • Resource Q
    • SP Sepharose
  • Hydrophobic Interaction Chromatography
    • (CH2)n Sepharose
    • Phenyl Sepharose
    • Size Exclusion Chromatography
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Clinical Research
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Clinical Trials, Consulting, and Management
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Biology
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Biochemistry & Molecular Biology
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Protein Services
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Protein Production
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Protein Quantification
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Antibody Services
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Nucleic Acid Services
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RNA Services
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Medical Devices & Diagnostics
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