High‑Performance Antibodies for IVD Manufacturers

Futratech Inc. develops and supplies **diagnostic‑grade** monoclonal and polyclonal antibodies as critical raw materials for in vitro diagnostic devices. From antigen design to hybridoma selection, purification, and release, every lot is traceable and backed by a COA.

Facility
9924 Mesa Rim Rd, Suite B
QC
Purity, binding, stability
Quality
ISO 9001 pathway

Quick OEM Inquiry

Tell us about the target and application.

Product Focus

Antibodies optimized for sensitivity, specificity, and manufacturability across IVD formats.

Monoclonal Antibodies (mAb)

Mouse ascites or cell culture; Protein A/G purification; format-ready for ELISA/LFA/CLIA.

  • High-affinity clones with subclones
  • Batch-to-batch traceability
  • Custom conjugation (optional)

Polyclonal Antibodies (pAb)

Rabbit or other species on request; affinity purification; QC across relevant matrices.

  • Antigen design support
  • Lot reservation & bridging
  • Stability data packages

OEM & Custom Supply

Catalog-to-OEM transitions, scale-up, and long-term agreements for IVD manufacturers.

  • COA with purity, binding, concentration
  • Controlled buffers & fill volumes
  • Temperature‑validated shipping

Capabilities

  • Antigen acquisition & design support
  • Mouse/rabbit immunization programs
  • Hybridoma fusion, screening & subcloning
  • Ascites & cell‑culture production
  • A/G purification, buffer exchange, fill‑finish
  • QC panels: SDS‑PAGE, ELISA, stability

Deliverables

  • COA with purity, concentration, binding data
  • Batch Production Record (BPR) summary
  • Storage & handling recommendations
  • Optional: pairing data for assay formats

Quality Management

Futratech operates under an ISO 9001 pathway with documented SOPs, lot traceability, and calibrated equipment. Each batch is reviewed against predefined specifications before release.

  • Traceable batch & lot numbering
  • Document control, CAPA, internal audits
  • Equipment calibration & maintenance logs
  • Temperature‑validated storage & shipping

Typical QC Panel

Purity
SDS‑PAGE / densitometry
Binding
ELISA titer / specificity
Concentration
A280 / BCA
Stability
accelerated / real‑time

From Antigen to OEM Supply

Our end‑to‑end workflow ensures performance and reproducibility for regulated IVD manufacturing.

  1. 01

    Antigen

    Recombinant/native antigen sourcing or design support.

  2. 02

    Immunization

    Mouse/rabbit programs with documented schedules.

  3. 03

    Fusion & Screening

    Hybridoma creation, ELISA screening, subcloning.

  4. 04

    Validation

    Small‑scale lots; specificity and performance checks.

  5. 05

    Production

    Ascites or cell‑culture; Protein A/G purification.

  6. 06

    Storage

    Controlled temp, labeled lots, inventory tracking.

  7. 07

    Catalog

    Product entry with specs & datasheets.

  8. 08

    OEM Supply

    Lot reservation, scale‑up, validated shipping.

About Futratech

Based in San Diego, Futratech Inc. partners with IVD companies to deliver reliable, scalable antibody raw materials. Our team brings hands‑on experience in hybridoma development, purification, and assay integration.

Address: 9924 Mesa Rim Rd, Suite B, San Diego, CA 92121, USA

Email: info@futratech.com

Why Manufacturers Choose Us

  • End‑to‑end control and traceability
  • Responsive OEM engagement & tech transfer
  • Pragmatic quality system; COA with every lot
  • Scalable production with bridging strategies

Contact & OEM Requests

Email us at info@futratech.com or use the form below.