How We Deliver Custom QC in 15 Days
Industry standard for custom QC: 10-12 weeks
UTAK delivery: 15 days
Not by cutting corners—by eliminating the inefficiencies built into traditional workflows.
Why Others Take 10-12 Weeks:
- 6–8 weeks waiting on matrix sourcing
- Supplier stockouts causing delays
- Sequential workflows (one step finishes before next begins)
- Layers of bureaucratic approvals
Why We Deliver in 15 Days:
- Pre-qualified supplier relationships ready to go
- Critical base materials in stock
- Parallel workflows (multiple steps happening simultaneously)
- Streamlined approvals without sacrificing quality
Your Product Journey: Order to Delivery
DAYS 1-3: Design & Material Preparation
Feasibility Assessment
Your specifications hit our product design team immediately. We verify compatibility against 50+ years of formulation experience.
For established analytes:
- Quick compatibility check with target matrix
- Confirm existing processes meet your specs
For new-to-us analytes:
- Solubility assessment in requested matrix
- Handling procedure verification
- Stability considerations based on analyte chemistry
Need formulation guidance? We can reference our database to confirm we’ve manufactured similar products—without disclosing other customers’ proprietary information.
Matrix Preparation
Source: All human matrices from healthy U.S. donors via reputable collection centers
Every matrix undergoes:
- Infectious disease screening (HIV, Hep B, Hep C)
- Drugs of abuse screening via in-house ELISA (urine, blood, serum, plasma)
- Filtration to remove particulates
Our proprietary REAL Process maintains native matrix integrity:
| What We DON'T Do | What We DO |
|---|---|
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Result: QC materials that perform like actual patient specimens in your assays.
Analyte Sourcing
Qualified tier-one suppliers only:
- Sigma-Aldrich / MilliporeSigma
- LGC Standards
- Cerilliant
- Other established reference material producers
- All suppliers qualified per ISO 13485 requirements
- Backup suppliers prevent stockout delays
- Continuous performance monitoring
DAYS 4-8: Hand-Crafted Manufacturing
Every product is hand-pipetted by trained technicians using calibrated equipment.
Why hand pipetting for custom formulations:
- Precision for complex multi-analyte panels
- Flexibility for unusual concentrations
- No equipment carryover between analytes
- Faster than automated setup for one-off batches
The Manufacturing Process:
1. Precise Measurement
- Plasma, serum, urine → measured by weight (precision scales)
- Whole blood → measured by volume (calibrated glassware)
- Critical: Even small measurement variances throw off final concentrations
2. Master Analyte Solution
Each analyte prepared accounting for:
- Analyte purity from supplier CoA
- Solubility requirements (correct solvent match)
- Stability considerations (some degrade if mishandled)
- Recovery factors (some analytes are “sticky”)
3. Sequential Spiking
- Analytes spike in specific order based on stability (not random)
- Continuous mixing ensures homogeneous dispersion
- Pipette tip rinsing prevents solution loss
- No contact between tips and glassware sides (prevents contamination)
- Extended final mixing (5+ minutes) after last spike
4. Final Mixing
- Careful matrix addition
- Mix until homogeneity confirmed
- Watch for foam/bubbles affecting consistency
Batch sizes: 50mL minimum → 50 gallons maximum
Benefit: Single-batch production eliminates lot-to-lot variation concerns
Documentation: Every major step includes sign-offs tracking who performed the action and when.
DAYS 9-12: Quality Verification
Our Approach to Quality
What we DON’T do:
- Standard potency testing on every custom product (unnecessary for unassayed QC material)
What we DO:
- Focus on process control—ensuring manufacturing consistency
- In-process checks during manufacturing
- Final physical inspection of vials
- Label accuracy verification
- Documentation completeness review
- Third-party verification available upon request (all stock products undergo third-party testing)
Acceptance criteria:
- Standard: ±25% from target concentration
- Need tighter? We implement additional controls to meet your requirements (±10%, ±15%, etc.)
DAYS 13-15: Packaging & Delivery
Validated Packaging
- Reinforced boxes with custom vial holders
- Protection during shipment and long-term storage
- Lab-grade bottles and caps minimize leaching
Complete Traceability
- Sequential lot numbering
- Trace finished product → raw material supplier lots → supplier CoAs
Documentation Included
- Instructions for Use (IFU) for spiked products
- Certificate of Analysis (CoA) for blank matrices (available on request for spiked)
- Safety Data Sheets (SDS) available on request
- UDI labeling (we handle FDA GUDID registration)
The Custom-2-Core Evolution
Here’s what makes us different:
Your custom formulation today → Other labs request similar specs → We add it to stock inventory → Faster turnaround + potentially better pricing
What this means:
- Your needs directly influence our product development
- Products validated by real-world use become accessible to broader community
- You benefit from faster access on reorders if your custom becomes stock
This is partnership, not just manufacturing.
Why Trust Our Process?
50+ Years of QC Manufacturing Experience
Formulation challenges we’ve solved:
- Difficult-to-solubilize analytes
- Unstable compounds requiring special handling
- Matrix compatibility issues
- Complex multi-analyte panels with competing solubility requirements
You’re not paying for us to learn on your project—you’re accessing decades of institutional knowledge.
The result:
- Faster development
- Fewer reformulation cycles
- QC materials that work the first time
