CDMO Solutions for BCR/TCR — From Discovery to GMP
End-to-end development and manufacturing for BCR/TCR reagents and cell therapies, spanning discovery, engineering, analytics, and cGMP production.
An Integrated CDMO Path for BCR/TCR Programs
BCR/TCR programs face unique hurdles, including antigen specificity, HLA restriction, off-target/toxicity risk, developability, scale-up, and regulatory evidence. We provide an integrated CDMO path—from antigen & repertoire discovery to reagent manufacture and TCR-T enabling CMC—reducing timelines and risk.
We solve key program pains:
- Antigen design & pMHC assembly
- Single-cell discovery & hit validation
- Affinity/avidity tuning & optimization
- Vector & cell process development
- Potency & off-target analytics
- Phase-appropriate quality & regulatory support
Who We Serve
We partner with a wide range of developers, from early-stage research teams to established biotechs, providing tailored solutions for their unique starting points.
Typical Segments
- Immuno-oncology biotech
- Autoimmune/ID researchers
- Platform companies (TCR discovery)
- Diagnostic kit developers (tetramers/multimers)
- Academic-to-spinout teams
Typical Starting Points
- Peptide/HLA hit validation
- Candidate TCR sequences
- BCR-derived mAb lead
- Need for GMP pMHC/tetramers
- Tech-transfer of an existing process
Our One-Stop Service Scope
We provide a fully integrated service portfolio covering the entire BCR/TCR product lifecycle, from initial discovery and engineering to full-scale cGMP manufacturing.
Discovery & Repertoire Enablement
- Antigen epitope mapping & peptide design
- pMHC monomer/multimer (tetramer/dextramer) production (RUO/GMP-like/GMP)
- Single-cell BCR/TCR repertoire (10x/plate-based)
- Antigen-specific B/T cell sorting, sequence recovery & annotation
- Hit ranking: specificity, cross-reactivity screens, predicted off-targets
Molecular Engineering
- TCR α/β chain pairing optimization, CD3-interaction tuning, co-receptor usage
- Affinity maturation (directed evolution/rational)
- Avidity engineering (dimerization/fusion scaffolds)
- BCR-to-mAb conversion & humanization
- Fc engineering (effector function, stability)
Expression & Process Development
- Soluble TCRs / pMHC / BCR fragments / antibodies in: E. coli, Yeast, Insect, CHO/HEK (selected by complexity/PTMs)
- Membrane TCR/BCR display reagents & stable cell line construction
- Upstream: Media/feed optimization, perfusion/batch
- Downstream: Multi-step chromatography, TFF, viral clearance
Vector, Cell, and Gene-Modified Therapy Enablement
- Lentiviral/AAV plasmid construction & GMP viral vector production (RCL/RCA control)
- Preparation of TCR-T enabling materials: pMHC reagents, controls, T-cell activation reagents
- Early T-cell process development (for non-clinical studies)
- Interfacing with GMP cell production transfer
Formulation & Fill/Finish
- Liquid/lyophilized formulation development
- Stability studies (accelerated/long-term)
- Aseptic filling, labeling, and finishing
- Container closure integrity testing
Regulatory & Documentation
- CMC writing support for IND/IMPD filings
- Comprehensive batch records (MBR/MRF/CoA)
- Method validation & transfer packages
- Full traceability and quality agreements
Core Technology Platforms
Our specialized platforms provide the foundation for rapid, high-quality development of your BCR/TCR candidates and reagents.
pMHC Production Platform
For antigen-specific T-cell detection, sorting, and TCR characterization.
- Multi-allele library (HLA-A/B/C; Class II)
- Biotinylation & tetramerization
- Quantitative binding & stability readouts
Single-Cell BCR/TCR Discovery
Isolate and validate antigen-specific receptors from complex populations.
- 10x Genomics / SMART-seq
- Antigen-specific enrichment
- High-throughput paired-chain recovery
Protein Expression
Flexible host systems to match your molecule's requirements for yield and PTMs.
- Microbial, Yeast, Insect (BEVS)
- Mammalian (CHO/HEK)
- Optional glycoform control
Viral Vector & Cell Suites
Dedicated suites for process development and GMP manufacturing of vectors.
- LV/AAV process development → GMP
- Segregated biosafety suites
- Closed processing systems
Dual Development Workflows
We offer distinct, parallel-track workflows for reagent development and cell therapy enabling materials, ensuring phase-appropriate progress.
A. Reagent/Assay Path (pMHC, soluble TCR, mAb)
| Stage | Services | Key Readouts |
|---|---|---|
| Target & Design | Epitope/pMHC/TCR/BCR design | HLA coverage, peptide stability |
| Expression Dev | Host & vector selection, DoE | Yield, purity, glycan/charge |
| Purification | Capture → Polish chromatography | HCP/HCDNA/Endotoxin levels |
| Analytics | ID, potency, specificity | BLI/SPR, ELISA, tetramer binding, LC-MS |
| Formulation | Buffer/lyophilization screening | Tm, aggregation, viscosity |
| GMP Production | MBR execution, release testing | CoA, stability data, traceability |
B. TCR-T Enabling Path (Materials & Vectors)
| Stage | Services | Key Readouts |
|---|---|---|
| Candidate Intake | Sequence verification, chain pairing | On-target binding/avidity |
| Off-Target Risk | Motif & proteome scans (in-silico/in-vitro) | Cross-reactivity matrix |
| Vector & Cell Dev | LV design, T-cell transduction | VCN, transduction rate, phenotype |
| Potency | Tumor killing/co-culture assays | Cytotoxicity, cytokines, exhaustion markers |
| Safety & Release (GMP) | RCL/sterility/mycoplasma/endotoxin | Specification-based pass/fail, CoA |
Comprehensive Analytics Panel
A full suite of analytical methods to ensure the identity, purity, potency, and safety of your BCR/TCR products.
-
Identity/Impurity
LC-MS/MS, CE-SDS, icIEF, Glycan profiling, Residual HCDNA/HCP, Endotoxin
-
Binding/Function
SPR/BLI (TCR-pMHC, BCR-antigen), cell-based potency assays, tetramer staining
-
Safety
Sterility, Mycoplasma, Bioburden, Replication Competent Virus (RCL/RCA) assays
-
Genetic
NGS identity verification, Vector Copy Number (VCN), integration site analysis (as needed)
-
Stability
Accelerated/real-time studies, forced degradation, photostability
Phase-Appropriate Quality & Regulatory Support
Our robust QMS ensures compliance and data integrity, from discovery to GMP, providing audit-ready documentation for global filings.
- Standards ICH Q5/Q6, Q7, Q9; applicable chapters USP <71>/<85>/<63>; Data Integrity (ALCOA+)
- Qualification & Validation MCB/WCB, method validation (accuracy, precision, LOD/LOQ, robustness), equipment & cleaning validation
- Audit-Ready Documentation Batch records, deviation/CAPA, change control, raw material traceability
- Global Readiness Experience with FDA, EMA, and NMPA engagement and filing requirements
ICH & cGMP COMPLIANT
PHASE-APPROPRIATE QMS
AUDIT-READY (FDA/EMA)
IND/IMPD SUPPORT
Capabilities & Use Cases
Applying our core platforms to solve challenges across immuno-oncology, autoimmunity, infectious disease, and diagnostics.
Immuno-oncology
TCR-T lead materials and scale-up; multi-HLA pMHC panels for neoantigen screening.
Autoimmunity
Self-antigen specific BCR/TCR detection and reagent manufacturing.
Infectious Disease
Viral/bacterial epitope pMHC tools and neutralizing mAb discovery/production.
Diagnostics
GMP-grade tetramer/dextramer manufacturing for diagnostic kit assembly.
Frequently Asked Questions
Find quick answers to common inquiries about our BCR/TCR CDMO services.
What is the difference between BCR and TCR CDMO support?
Our TCR support focuses heavily on pMHC-TCR interactions, HLA restriction, off-target screening, and TCR-T enabling materials (like viral vectors). Our BCR support focuses on B-cell repertoire mining for antigen-specific hits, conversion of BCR sequences into monoclonal antibodies (mAbs), and subsequent mAb engineering (humanization, Fc-tuning) and cGMP manufacturing.
How do you assess TCR off-target risks?
We use a multi-step approach. It starts with in-silico screening of your TCR candidate against peptide motifs and the human proteome. This is followed by in-vitro screening, such as binding assays against a panel of pMHCs with similar peptide sequences or allogeneic pMHCs to check for non-specific HLA binding. For cell therapy, further cell-based co-culture assays with off-target cell lines may be performed.
Which HLA alleles can you support for pMHC?
We maintain an extensive, ever-growing library of common and rare HLA alleles, including HLA-A, -B, -C (Class I) and various HLA-DR, -DP, -DQ (Class II) alleles. Please contact us with your specific allele and peptide of interest for a detailed feasibility assessment.
Can you transfer in my existing sequences/process?
Yes. We have a dedicated tech transfer team that can manage projects starting from candidate sequences (TCR/BCR), a research-grade cell bank, or an established bench-scale process. We perform a gap analysis and work with your team to optimize and scale the process for cGMP production.
Do you offer GMP-grade tetramers and vectors?
Yes. We offer pMHC multimers (tetramers/dextramers) at RUO, GMP-like, and full cGMP grades, suitable for research, clinical assays, or diagnostic kit components. We also have dedicated cGMP suites for the production of lentiviral (LV) and adeno-associated viral (AAV) vectors for clinical use.
What release tests are required for pMHC vs. LV?
For a cGMP pMHC reagent, key tests include Identity (e.g., LC-MS), Purity (HPLC, CE-SDS), Potency (binding to a reference TCR or Ab), Endotoxin, Bioburden, and Sterility. For a cGMP Lentiviral Vector, the panel is more extensive, including Identity, Purity, Titer (functional & physical), VCN, Potency (transduction & expression), Endotoxin, Mycoplasma, Sterility, and Replication Competent Lentivirus (RCL) testing.
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