Biopharmaceutical Solutions

Biologics refer to pharmaceuticals composed of large biological molecules, typically encompassing categories such as cytokines, hormones, antibodies, cell therapy products, enzymes, blood products, gene therapy drugs, and vaccines. Within the biologics market, monoclonal antibodies (mAbs), recombinant proteins, vaccines, and cell therapies account for the vast majority of market share. In recent years, driven by technological advancements and industrial restructuring, the market size of biologics in China has demonstrated a steady upward trend.

It is well known that new drug development is a complex endeavor requiring collaboration across multiple disciplines and departments, facing significant risks including high investment, long development cycles, and low success rates. High-quality raw materials are crucial for accelerating drug approval. As a leading domestic supplier of premium raw materials, TransGen Biotech is committed to meeting the diverse needs of its clients in biologics development. To support the research, development, and commercialization of vaccines and cell therapy drugs, TransGen offers a comprehensive Biologics Development Solution,  including those for: mRNA In Vitro Transcription & Modification, Cell Culture, Transfection Reagents, Cell Assays, Fluorescently Labeled Antibodies, Universal Endonucleases, Quality Control products, such as those for host cell DNA residue extraction and detection.

Vaccines

Vaccines can be primarily categorized into nucleic acid vaccines (such as mRNA and DNA vaccines), viral vaccines (including live attenuated, inactivated, and viral vector vaccines), and recombinant protein vaccines. Among these, mRNA vaccines have garnered significant attention due to their safety, high efficacy, and streamlined production, demonstrating immense potential for future development. Viral vaccines, with their mature production processes and stable immunogenicity, are widely used in vaccine manufacturing.

As a leading domestic supplier of high-quality biological reagents, TransGen Biotech offers a comprehensive solution for mRNA in vitro synthesis. This solution supports the entire workflow, from plasmid and template preparation, through mRNA in vitro transcription, capping, and tailing, to sample purification.

mRNA Vaccines

Endotoxin-Free Plasmid Extraction

EasyPure^® 1-Tube Universal EndoFree Pro Plasmid Maxi Prep Kit (for 100-500 ml culture) (EM153)

•Single-Tube Workflow: The entire process of bacterial lysis and neutralization for a 100-500 ml culture is completed within a single 50 ml tube, eliminating the need for large containers.

•Visual Process Monitoring: The LB III allows clear visual tracking of the lysis and neutralization steps, ensuring complete reactions and consistent, high-quality plasmid preparation.

•Rapid Procedure: Significantly reduce the number of required centrifugation steps and saves  time.

•Ultra-Low Endotoxin: The purified plasmid achieves endotoxin levels below 0.1 EU/μg, with levels as low as 0.001 EU/μg.

•High Yield: The purification column features a high nucleic acid binding capacity of up to 5 mg.

In vitro transcription

T7 High Efficiency Transcription Kit (JT101)

This kit utilizes T7 RNA Polymerase to efficiently transcribe DNA sequences downstream of a T7 promoter, using supercoiled plasmid DNA or linearized DNA containing the T7 promoter as a template.

•High Yield: A single 20 μl reaction can produce >200 μg of RNA.

•Excellent Template Compatibility: Suitable for transcription from various templates, including linearized plasmids, purified PCR products, and synthetic DNA fragments, with a recommended input range of 1 ng to 2 μg. Supports transcription of fragments over 6 kb.

•High Flexibility: The reaction setup can be easily scaled up or down according to experimental needs. Compatible with cap analogs and chemically modified nucleotides.

•High Quality: Produces RNA with high purity and excellent integrity.

mRNA Capping Kit (LC101)

This kit contains vaccinia virus capping enzyme, mRNA cap 2'-O-methyltransferase, and other essential reaction components. It is designed for adding 5' cap structures to RNA generated by T7 in vitro transcription (e.g., using Kit JT101).

•High Efficiency: Achieves high capping efficiency, resulting in capped mRNA with superior stability and high translation efficiency upon transfection.

•Simple & Fast: The vaccinia virus capping enzyme and 2'-O-methyltransferase are combined in a single reaction mix, enabling the production of Cap 1-capped mRNA in just one hour.

•High Flexibility: Compatible with mRNAs of varying lengths, and the reaction scale can be easily adjusted up or down based on experimental requirements.

•Complete Reaction System: Supplies high-quality GTP and SAM as capping substrates. Users only need to provide their own RNA to initiate the capping reaction.

mRNA Poly(A) Tailing Kit (LA201)

The reaction catalyzes the conversion of ATP to AMP, sequentially adding adenosine monophosphate to the RNA's 3' terminus.

•High Efficiency: Achieves highly efficient tailing with a uniform and consistent poly(A) tail length.

•High Flexibility: The reaction scale can be easily adjusted up or down to meet specific experimental needs.

•Simple & Fast: Capped mRNA can be directly used as the substrate for the tailing reaction with this TransGen kit (LA201), streamlining the workflow.

•Complete Reaction System: The reaction buffer contains the necessary ATP. Users only need to provide their RNA to initiate the tailing reaction.

mRNA Transfection

TransIntro^® mRNA Transfection Reagent (FT501)

•High Transfection Efficiency: Provides superior transfection efficiency for suspension cells and primary cells.

•Low Cytotoxicity: Minimally impacts normal cellular physiology, ensuring better cell health and viability post-transfection.

•Simple Protocol: No medium change is required after transfection, and the process is compatible with media containing serum and antibiotics.

Viral Vaccines

TransIntro^® PEI Transfection Reagent (GMP Grade) (FT401)

This reagent is animal-origin-free, exhibits low cytotoxicity and high transfection efficiency, and features a simple protocol. It is suitable for DNA transfection and multi-plasmid co-transfection in cell lines such as HEK-293, and is ideal for large-scale recombinant protein expression and virus production.

•Broad Application: Suitable for both transient and stable transfection in a wide range of adherent and suspension cells, including HEK-293.

•High Transfection Efficiency: Enables highly efficient plasmid DNA delivery, achieving greater than 90% transfection efficiency in HEK-293 cells.

•Low Cytotoxicity: Maintains excellent adherent cell morphology post-transfection and supports over 90% viability in suspension cells at 24 hours.

•Simple Protocol: No medium change is required before or after transfection. Compatible with media containing serum and antibiotics.

•Manufactured under GMP Standards: Produced and controlled in accordance with Good Manufacturing Practice (GMP) guidelines.

Cell Therapy

Cell therapy is primarily categorized into stem cell therapy, immune cell therapy, and other somatic cell therapies. Stem cells, owing to their capabilities for multidirectional differentiation, immunomodulation, and secretion of cytokines, represent a core area of research in the field. Immune cell therapy plays a critical role in oncology, with CAR-T therapy having demonstrated significant success in treating hematologic malignancies and emerging as a major focus within immune cell therapies.

The standard CAR-T manufacturing process includes T cell collection, separation, purified T cell cryopreservation, T cell activation, transduction, expansion, followed by CAR-T harvest & formulation, and final product testing.

TransGen Biotech provides a comprehensive portfolio of products supporting key steps in cell therapy development, including Cell Separation, Cell Culture, Cell Differentiation & Identification, Cell Transfection, Immune Cell Subset Analysis.

Stem Cell Therapy

Human MSC Characterization Kit (HF001)

•Monoclonal Antibodies: High specificity and sensitivity.

•Directly Conjugated: Ready-to-use primary antibodies eliminate the need for self-conjugation, saving time and simplifying the workflow.

•Direct Target Binding: Unaffected by endogenous antibodies, minimizing non-specific adsorption.

•Superior Quality: Excellent batch-to-batch consistency and reproducibility.

Immune Cell Therapy

Human Peripheral Blood Lymphocyte Separation Solution (FB102)

This is a sterile, near-isotonic solution of dextran and meglumine diatrizoate with a density of (1.07 ± 0.001) g/ml (20°C), designed for the isolation of lymphocytes from human peripheral blood.

•Near-Isotonic Osmolality: The osmotic pressure is similar to that of human peripheral blood cells, ensuring minimal cell damage during separation.

•High Cell Yield: Typically recovers over 1×10⁶ lymphocytes per milliliter of whole blood.

•Excellent Cell Viability: Maintains high lymphocyte viability, consistently exceeding 95% post-isolation.

•Ready-to-Use & Sterile: The solution is supplied ready for use under sterile conditions. The isolated lymphocytes are suitable for subsequent in vitro culture and immunological assays.

ArtMedia^® Human T Cell Serum-Free Medium (GMP Grade) (MT101)
ArtMedia^® Human T Cell Serum-Free Medium, no phenol red (GMP Grade) (MT102)

A specialized, serum-free, and xeno-free medium designed for the efficient expansion of T cells derived from cord blood or peripheral blood.

•Proprietary Formulation: Developed through independent R&D.

•Defined Composition: Serum-free, xeno-free, and chemically defined, ensuring consistency and reducing risk of contamination.

•High-Performance Expansion: Supports rapid T cell proliferation and high-density culture.

•High Flexibility: Compatible with various T cell activation methods, including soluble antibodies, antibody-coated plates, and bead-conjugated antibodies.

•GMP Manufacturing: Produced and controlled in compliance with Good Manufacturing Practice (GMP) standards.

Lentiviral Titer Detection

TransLv^TM Lentivirus qPCR Titration Kit (FV201)
This kit uses a qPCR method to detect the copy number of integrated proviral sequences in lentivirus-transduced cells. The method is simple, rapid, highly sensitive, efficient, and compatible with both 2nd and 3rd generation HIV-1 lentiviral packaging systems.

•Simple & Sensitive: Streamlined workflow with high detection sensitivity.

•Accurate Quantification: Includes a reference gene for normalization, ensuring more accurate lentiviral titer measurement.

•Broad Compatibility: Compatible with both 2nd and 3rd generation HIV-1 lentiviral packaging vectors.

•Wide Detection Range: The standard curve exhibits excellent linearity across a broad range of 10³ to 10⁸ copies/μl.

HIV-p24 ELISA Kit (NE107)
This kit determines the physical titer of lentivirus by detecting the concentration of the p24 capsid protein in lentiviral lysates.

•Wide Detection Range: 3.13 – 200 pg/ml.

•High Sensitivity: Detection limit as low as 1.0 pg/ml.

•High Specificity: Utilizes a high-affinity monoclonal antibody.

•Excellent Reproducibility: High lot-to-lot and well-to-well consistency with low variability; intra-assay CV <10%, inter-assay CV <15%.

•Simple Procedure: All necessary reagents are supplied in the kit; users only need to provide deionized water and culture medium.

HIV-p24 ELISA Kit (One-step) (NE109)
This kit determines the physical titer of lentivirus by detecting the concentration of the p24 capsid protein in lentiviral lysates, featuring a simplified one-step procedure.

•Wide Detection Range: 31.3 – 2000 pg/ml.

•High Sensitivity: Detection limit of 10.0 pg/ml.

•High Specificity: Utilizes a high-affinity monoclonal antibody.

•High Precision: Intra-assay CV <10%, inter-assay CV <15%.

•Rapid & Simple Workflow: Requires only a single sample loading step, with a total incubation time of just 70 minutes.

Biopharmaceutical Quality Control

Quality control is essential for ensuring the safety and efficacy of biopharmaceuticals and represents a critical step in the manufacturing process. The implementation of rational and accurate testing methods to control the quality of biologics is therefore of paramount importance. Building upon its established technology platforms, TransGen Biotech has developed a range of products for mycoplasma testing and host cell DNA residue extraction and detection. These solutions are designed to meet the stringent quality control requirements of the biopharmaceutical industry and empower the high-quality development of biologics.

Mycoplasma Detection

TransDetect^® qPCR Mycoplasma Detection Kit (FM321)
This kit utilizes a TaqMan real-time quantitative PCR method to detect mycoplasma DNA and is intended for the qualitative detection of mycoplasma contamination in samples such as culture media, cell cultures, and biological products. It offers broad detection coverage across the class Mollicutes, including various Mycoplasma, Acholeplasma, and Spiroplasma species. The kit has been validated according to the relevant guidelines and requirements of European Pharmacopoeia (EP) 2.6.7 and Japanese Pharmacopoeia (JP) G3 for mycoplasma testing.

•Compliance with Pharmacopoeia: Meets the requirements for mycoplasma testing using Nucleic Acid Amplification Techniques (NAT) as specified in EP 2.6.7 and JP G3.

•Broad Coverage: Validated for detecting 13 mycoplasma strains and plasmid DNA; in silico analysis confirms coverage of at least 129 mycoplasma DNA sequences.

•High Sensitivity: Validated mycoplasma strains meet the 95% detection limit requirement, with a detection limit of up to 10 CFU/ml. The plasmid standard can be detected at 1 copy/μl.

•High Specificity: No cross-reactivity or interference observed with genomes from nearly 20 common bacterial species or production cell lines.

•dUTP/UDG Anti-contamination System: Effectively prevents contamination from PCR amplicons, ensuring data accuracy.

•High Stability: The kit can undergo at least 15 freeze-thaw cycles without significant impact on performance.

•Wide Instrument Compatibility: Compatible with mainstream real-time PCR instruments, ensuring consistent results.

TransDetect^® Luciferase Mycoplasma Detection Kit (FM301)

•Simple & Fast Procedure: Requires only two operational steps, providing results in just 20 minutes.

•High Sensitivity: Capable of detecting levels as low as 50 CFU/ml, effectively reducing the risk of false-negative results.

•Excellent Reproducibility: High well-to-well consistency ensures more accurate result interpretation.

Host Cell Residual DNA Extraction and Detection

MagicPure^® Host Cell Residual DNA Kit (EH201)
This kit employs a unique lysis buffer to efficiently release trace amounts of DNA, followed by purification using silica-coated magnetic beads that specifically adsorb and purify host cell residual DNA.

•Simple & Fast Procedure: Easy-to-follow protocol with no centrifugation steps required, enabling rapid extraction.

•High Purity: Delivers DNA of high purity, suitable for sensitive downstream applications.

•High Recovery Yield: Efficiently extracts trace DNA fragments from host cells (e.g., CHO, Vero, NS0, MDCK) from biological samples of ≤ 200 μl.

•Automation-Compatible: Can be paired with high-throughput magnetic rod-based automated nucleic acid extraction systems.

PerfectStart^® Vero DNA Quantification Kit (DH111)
PerfectStart^® CHO DNA Quantification Kit (DH121)
PerfectStart^® E.coli DNA Quantification Kit (DH131)
PerfectStart^® Pichia DNA Quantification Kit (DH141)
PerfectStart^® SV40 LTA & E1A DNA Quantification Kit (DH151)
PerfectStart^® HEK293 DNA Quantification Kit (DH152)

These kits are designed for the specific, sensitive, and stable quantitative detection of residual DNA from various host cells (Vero, CHO, E. coli, Pichia, 293T/HEK293) in biological products.

•High Specificity & Sensitivity: Utilizes a 3-antibody hot-start system, ensuring high specificity, sensitivity, amplification efficiency, and a broad linear dynamic range.

•Anti-Contamination System: Incorporates UDG enzyme and dUTP to effectively prevent carryover contamination from PCR amplicons, guaranteeing data accuracy.

•Strong Specificity: No cross-reactivity observed between different host cell lines.

•High Accuracy: Detection deviation for DNA standards is less than 5%.

•Robust Performance: Results are unaffected by DNA fragmentation, and the assays are compatible with a wide range of real-time PCR instruments.

Copy Number Detection

PerfectStart^® CAR/TCR Quantification Kit (DH181)

•High Specificity & Sensitivity: Utilizes a 3-antibody hot-start system, ensuring high specificity, sensitivity, amplification efficiency, and a broad linear dynamic range.

•Optimized Reaction Buffer: Features a specially optimized qPCR buffer that enables higher extension speed, sensitivity, and specificity.

•Anti-Contamination System: Incorporates UDG enzyme and dUTP to effectively prevent carryover contamination from PCR amplicons, ensuring data accuracy.

•Wide Instrument Compatibility: Compatible with a broad range of real-time PCR instruments.

•Exceptional Stability: Maintains full performance after 10 freeze-thaw cycles or storage for 14 days at 4°C, room temperature, and 37°C.

Process Residue Testing

Universal Nuclease ELISA Kit (NE110)

•High Sensitivity & Wide Range: Limit of Detection (LOD) is 7.97 pg/ml, with a broad linear range of 31.25–2000 pg/ml.

•High Specificity & Accuracy: No non-specific binding with various common samples, demonstrating strong anti-interference capability.

•Stable Performance: Excellent precision, both within a batch and between batches.

•Broad Compatibility: Widely applicable for the quantitative detection of various nucleases available on the market.

TransDetect^® Fluorescence DNase Detection Kit (FM601)

•High Sensitivity: Capable of detecting as low as 0.001 U of DNase I.

•High Specificity: The detection reaction is not interfered with by RNase A.

•Rapid Detection: The assay can be completed in just 1 hour.

•Accurate Data: Provides reliable and precise results.

TransDetect^® Fluorescence RNase Detection Kit (FM611)

•High Sensitivity: Capable of detecting as low as 0.3 pg of RNase A.

•High Specificity: The detection reaction is not interfered with by DNase I.

•Rapid Detection: The assay can be completed in just 1 hour.

•Accurate Data: Provides reliable and precise results.

Residual Trypsin ELISA Kit (NE112)

•High Sensitivity & Wide Range: Limit of Detection (LOD) is 38.5 pg/ml, with a linear range of 0.047–3 ng/ml.

•Stable Performance: Excellent precision, both within a batch and between batches.

•Broad Compatibility: Suitable for the detection of residual recombinant or natural trypsin in biological products.

Reagents for Biopharmaceutical Discovery and Analysis

TransGen Biotech also provides a comprehensive portfolio of molecular and immuno-diagnostic raw materials, cell biology reagents, and immunofunction analysis products to support the entire biopharmaceutical R&D and manufacturing workflow.

Cell Viability Assays

TransDetect® Cell Counting Kit (CCK) (FC101)
This kit utilizes a water-soluble tetrazolium salt for cell proliferation and cytotoxicity assays. Faster proliferation, lower cytotoxicity, and a higher number of cells result in a darker color, which exhibits an excellent linear correlation with the cell count.

•Rapid & Sensitive: Provides quick and highly sensitive detection.

•Low Cytotoxicity: Minimally impacts cell health during the assay.

•Wide Linear Range: Offers a broad dynamic range for accurate quantification.

•Stable & Reproducible: Delivers consistent and reliable results.

TransDetect^® Luminescent Cell Viability Detection Kit (FC401)
This kit determines cell viability or quantifies the number of viable cells by measuring intracellular ATP levels via an ATP-dependent luciferase-catalyzed luminescence reaction.

•Simple Procedure: Single-reagent formulation enables cell lysis in just 10 minutes; suitable for high-throughput screening.

•High Sensitivity: Capable of detecting as few as 5 cells.

•Excellent Stability: Luminescence signal has a half-life of up to 3 hours; maintains good linearity even after storage at room temperature for 7 days.

•Broad Linear Range: Exhibits excellent linear correlation across a wide range of 5 to 100,000 cells.

Firefly Luciferase Reporter Gene Assay

TransDetect^® Single-Luciferase (Firefly) Reporter Assay Kit (FR101)
This kit uses luciferin as a substrate to detect the activity of the firefly luciferase reporter gene.

•Rapid Detection: Provides fast results.

•High Sensitivity: Capable of detecting very low levels of luciferase activity.

•Broad Detection Range: Suitable for quantifying a wide range of expression levels.

•No Endogenous Interference: Unaffected by intrinsic cellular activity, ensuring specific detection.

TransDetect^® Bio-Luc Firefly Luciferase Reporter Assay Kit (FR103)
A highly sensitive, stable, and homogeneous firefly luciferase reporter assay system. This kit enables rapid and efficient direct measurement of intracellular luciferase expression without the need for washing or cell harvesting steps.

•Simple Procedure: One-step, "add-and-read" protocol requires no washing or cell collection.

•High Stability: The luminescence signal has an extended half-life of up to 1 hour.

•Rapid Workflow: The entire procedure can be completed in just 5-10 minutes.

•Pre-validated per ICH Guidelines: Key performance parameters including repeatability, accuracy, precision, linearity, and specificity have been validated according to ICH guidance recommendations.

"Pharmaceutical Grade" Cell Cryopreservation Medium

TransStem^® Chemically Defined Xeno-free Cell Cryopreservation Medium III - DMSO Free, Protein Free (MC131)

A chemically defined, xeno-free, DMSO-free, and protein-free cryopreservation medium manufactured exclusively with "Pharmaceutical Grade" raw materials. It is suitable for a wide range of cell types, including mesenchymal stem cells and lymphocytes, offering excellent stability and effectively enhancing post-thaw cell viability.

•Chemically Defined & Xeno-free: Formulated without animal-derived components, ensuring batch-to-batch consistency and stability.

•DMSO-free: Eliminates the cytotoxicity associated with dimethyl sulfoxide (DMSO).

•Pharmaceutical Grade Raw Materials: Produced entirely with "Pharmaceutical Grade" ingredients, supported by toxicity testing, making it suitable for use as a cell therapy excipient.

•Protein-free: Ideal for protein-expressing cells, preventing potential interference.

•Simple Freezing Protocol: No programmed cooling is required; cells can be frozen directly at -80°C. For long-term storage, vials can be transferred to liquid nitrogen after overnight storage at -80°C.

•Broad Compatibility & High Viability: Applicable to most cell types, especially DMSO-sensitive and protein-expressing cells, achieving post-thaw viability rates exceeding 90%.

ELISA Kits

Human IL-6 ELISA Kit (NE101)
Human IL-10 ELISA Kit (NE102)
Human IL-12 p70 ELISA Kit (NE103)
Human TNF-α ELISA Kit (NE104)
Human GM-CSF ELISA Kit (NE105)
Human FGF basic ELISA Kit (NE106)
Human IL-1β ELISA Kit (NE108)
Human IL-2 ELISA Kit (NE111)

These kits demonstrate high specificity, superior sensitivity, and a user-friendly protocol.

•High Specificity: Utilize high-affinity antibodies for exceptional target specificity.

•High Sensitivity & Broad Range: Capable of detecting target analytes at pg/ml levels, featuring a wide linear detection range.

•Ready-to-Use: Supplied with pre-coated plates, streamlining the assay procedure for simplicity and convenience.

GMP Grade Universal Nuclease

Universal Nuclease (GMP Grade) (LN201)

This enzyme non-specifically cleaves nucleic acids at any nucleotide bond within the strand, degrading DNA and RNA into 2-5 base 5'-monophosphate oligonucleotides. It efficiently degrades all forms of nucleic acids (double-stranded, single-stranded, circular, or linear) without causing protein hydrolysis. It is widely used to remove nucleic acid residues and contamination from biopharmaceutical products.

•High Purity & High Specific Activity: Purity ≥ 99%, Specific Activity ≥ 1.0 × 10⁶ U/mg.

•Strong Adaptability: Highly stable and tolerant, maintaining significant stability and reactivity under challenging conditions including 6 M Urea, 0.1 M Guanidine HCl, 0.4% Triton X-100, 0.1% SDS, 1 mM EDTA, and 1 mM PMSF. Compatible with various cell lysis buffers (e.g., RIPA) and protein extraction reagents containing various ionic/non-ionic detergents and reducing agents.

•High Production Standards: Manufactured under GMP conditions, suitable for large-scale use from R&D to commercial production.

•Compliant with Pharmacopoeial Requirements: Animal-origin-free, antibiotic-free, and endotoxin-free.