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Services

Built for every stage
of your program.

From early candidate engineering through commercial supply, our capabilities span the full development journey — so your program never has to restart with someone new. Filter by where you are.

Synthetic Biology &
Genetic Design Construct architecture, ML-driven optimization, and proprietary tools for novel cell & gene therapy candidates. DiscoveryIND-enabling +
Construct & vector design — gene-of-interest, promoter, regulatory element optimization
Machine-learning sequence optimization & high-throughput screening
Cell-specific promoter engineering and kill switches
Targeting / detargeting molecules & novel envelope design
Custom stable producer cell line engineering
VLP and next-generation delivery platform development
Process Development A development team that operates closer to real-life production — building processes that translate to GMP from day one. IND-enablingClinical +
Risk assessment from batch records & process descriptions — gap analysis before kickoff
Unit operation design & optimization across autologous and allogeneic workflows
Scale-up and scale-out strategy — G-Rex, Wave, Vertical Wheel, stir tank
Engineering runs with on-the-floor MSAT support
Phase-appropriate development plans — never one-size-fits-all
Cost-of-goods modeling alongside process design
Analytical &
Assay Development Methods designed to be both scientifically meaningful and operationally robust — built early, qualified for the clinic. IND-enablingClinicalCommercial +
Identity, purity, potency, and safety method development for CGT products
Flow cytometry, dPCR / qPCR, ELISA, Luminex, cytotoxicity assays
Multi-parameter functional assays — moving beyond single-marker measurements
Bridges between research, GMP, and QC — close collaboration with SynBio & manufacturing
Phase-appropriate qualification & validation
Custom assay development for novel modalities & complex products
cGMP Manufacturing Seven Grade B suites in Alameda. End-to-end cell therapy drug product and viral vector starting material — at clinical scale, with a path to commercial. ClinicalCommercial +
Cell therapy GMP — CAR/TCR-T, CAR-NK, Treg (autologous & allogeneic)
Viral vector production — LVV, GRV; adherent 2-20L, suspension to 200L GMP
Cryopreservation, formulation, fill/finish — bags & vials
Cell banking — ECL · MCB · WCB generation
Tailored MSAT support & closed/functionally closed systems
Trained operators with ≥ 99.5% aseptic processing success
Stability Studies Stability data that holds up to regulators — designed to support product development, clinical manufacturing, and commercial lifecycle management. IND-enablingClinicalCommercial +
Stability protocol design & regulatory support
ICH and product-specific stability study execution
Real-time, accelerated, and stress stability studies
Clinical and commercial stability programs
In-use, hold-time, and shipping stability studies
Stability-indicating analytical testing
Trending, statistical data analysis & OOT / OOS investigations
Shelf-life determination, extension studies & lifecycle reports
Stability Sample Storage Secure, monitored, GMP-compliant sample storage with traceability and chain of custody from receipt through final data reporting. IND-enablingClinicalCommercial +
Qualified, temperature-mapped stability chambers
Controlled ambient, refrigerated, frozen & ultra-low temperature
Customized storage conditions to product requirements
Continuous environmental monitoring with alarm notification
Secure chain of custody & sample tracking
Pull scheduling, testing coordination & sample management
Backup power, business continuity & audit-ready records
Retrieval, shipping & distribution support
Quality Control & Release In-house microbiology, raw material testing, and full release panels. Patient-safety driven, ICH- and/or USP-aligned. ClinicalCommercial +
In-house micro: endotoxin, sterility, mycoplasma, environmental monitoring
In-house raw material testing & FTIR identity (a new client-requested capability)
Full release panel — viability, identity, purity, potency, vector copy number
Suitability studies & method validation per USP / EP standards
Environmental monitoring PQ for client-specific suite configurations
One of the largest functional teams in the company — by design
Tech Transfer &
Regulatory CMC Knowledge transfer is the #1 bottleneck in successful programs — we treat it as a discipline, not a checkbox. IND-enablingClinicalCommercial +
Structured gap assessments across process, analytical, and quality
Engineering runs with delta analysis & corrective design
Development-to-GMP transfer in ~6 months; commercial-to-commercial up to 24 months
CMC strategy & regulatory authoring support (IND, IMPD, BLA)
Dedicated PMO, transparent Gantts, routine data exchange via cloud platform
Inspection readiness as the default state, not a project

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