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IVD Solutions

SDIX and the IVD clinical assay industry: Celebrating 20 years

The clinical diagnostic industry has been experiencing dynamic changes over the last two decades. New products, new detection methods, new markets, and new targets...The only constant factors are newness and change. At the same time, other driving forces, like low reimbursement rates, compelling demand from the healthcare segment for more accurate and sensitive assays, and international competition are putting enormous pressure on In-Vitro Diagnostic companies.

Even though technologies are getting newer, the clinical assay market is growing at a slow rate. A slow, but steadily growing market and declining sales for old assays are also becoming the major challenges. To adapt, IVD companies are employing various market-oriented strategies to these changes, including:

  • Product development (Diagnostic menu expansion)
  • Increasing the breadth of the product line (Disease-based menu Filling)
  • Improve the quality with cost reduction etc (Product leadership with operation efficiency)

What has become abundantly clear is that In-Vitro Diagnostic companies are expected to provide high performance from limited resources. As a critical reagent provider to the IVD industry, SDIX understands fully the dynamics of this market. That is why we keep refreshing and updating SDIX, from our immuno-tools and services to our business processes, all to be the best fit for an IVD business’ needs.

SDIX expertise: Clinical Assay Reagents -Antibodies, Calibrators and Control


20 years of experience in the antibody field, combined with bulk production abilities, makes SDIX a perfect choice for an IVD company’s reagent requirements. Our expertise in antibody development and production, along with our IVD client’s expertise in assay development, creates synergies that can help IVD companies bring new assays into the market faster. SDIX’s bulk production and inventory management services can also help our clients reduce time, cost, and effort. 



A Complete Solution for IVD reagents

IVD Handwriting

IVD Solutions

Diagnostic Menu Expansion

SDIX offers various services in the antibody and assay field to expand diagnostic menus on our client’s automated platforms. A leading principle behind our offering is to guide our clients from early assay development to late production or marketing stage without losing the connection between development and production phases.

Co-Development of Analyte-Specific Reagents

SDIX offers collaborative options for reagent development for our customers. Our partner-oriented approach is intended to increase the overall efficiency and speed of the assay development process. By managing the immuno-reagent part completely, we help clients save time and effort in the reagent development process, enabling them to work on more projects simultaneously and focus on critical areas like assay optimization and validation.

Clinical Assays

Antibodies are the backbone of every immunoassay system. Immunoassays are basically mechanisms to measure the level of antigen-antibody reaction. Choice of right antibodies is important for its success.  For both quantitative and qualitative clinical assays, assay performance standards continue to increase, demanding more sensitivity and specificity in today’s diagnostic market.

Custom Formulation of IVD Reagents

SDIX is expert in custom formulation of IVD reagents.  Through understanding our client’s specific reagent requirement, we blend reagents, exactly as it needed for IVD client’s platforms. We consider various factors such as Low End Sensitivity, Linearity/Slope, Dynamic Range, and Prozone for custom formulation.

Large Scale Production

Large scale, regulatory compliant production (in-vitro and in vivo.) SDIX offers large scale antibody production services of client’s cell line as well as in-house developed cell lines with cost efficiency, supply surety, and transparent product management.

Bioprocessing

SDIX offers a number of bioprocessing packages for monoclonal and polyclonal antibodies, including Protein A / Protein G purification, Affinity Purification and more.

Commerically Proven IVD Analytes

Analyte

MS Anti-Hu Troponin-I (24-40)

Apo B

Strep A

CRP

CRP-IgG

AGP (Alpha 1 acid Glyco Protein)

Albumin (ALB)

C3

C4

CER (Ceruloplasmin)

Haptoglobin (HPT)

IgA (IGA)

IgG (IGG)

IgM (IGM)

Human RBC

cyclic AMP

Trinitrotoluene (TNT)

Calibrators -1,3,4 & 7

Calibrator 1

Calibrator 3

Calibrator 4

Calibrator 7

Calibrators - Custom

Vendor Management

One System for All Sites

 

Secure, state-of-the-art online and IT infrastructure 

 

Major Components

 

  • Document Control (Limited Access, Approval and Revision Control)

  • Nonconformance Reporting (Corrective Actions/Preventive Actions)

  • Equipment Maintenance (Notification of PM/Calibration, Logs, Manuals)

  • Training Management System

  • Internal/External Auditing Functions

  • Supplier Quality

Cell Line Services

Cell banking provides a stable uniform source of hybridoma cells for monoclonal antibody production. Your cell line is used for generation of a Platinum Master Cell Bank or a Gold Master Cell Bank and a Manufacturer’s Working Cell Bank.  SDIX provides safe and reliable storage for all of your cell lines with dual site storage for all Master Cell Banks.

Star Account Login

Star Account Login -- Use the STAR system to place your Genomic Antibody orders and to check the status of your custom antibody projects.