Biotech Firm 2016-11-30T23:43:25+00:00


Biotech firm develops an inexpensive, fast test for Hepatitis B and Chlamydia targeted to serve the needs of developing countries in Africa and Asia.

Client Business Need

This bio-tech firm applied and received approval for assistance through NIH SBIR Manufacturing Assistance Program to plan for and move toward manufacturing readiness.

In anticipation of demand and production requirements to meet 100,000 units of production per month (from 10,000), the company engaged Manex to review and understand their current manufacturing processes with the objectives of identifying bottlenecks, opportunities for improvement and/or automation, and critical Control Points from a quality perspective.


Using a comprehensive approach of documenting the current manufacturing process, analyzing and synthesizing opportunities and identifying critical control points (CCPs), Manex recommended high-level future/ideal manufacturing processes. In addition, Manex reported on opportunities for automation and efficacy.

  • Development of a current state process to identify manufacturing bottlenecks, CCPs and areas for improvement.
  • Key processes were evaluated, providing specific recommendations to ramp for high volume production.

Results Delivered

Manex provided the company with an in-depth analysis of the overall manufacturing process with specific recommendations to reduce bottlenecks and scale up effectively to achieve their high volume production goals of 100,000 units of production per month.

Specific productivity improvements include:

  • Reduce the amount of labor required in the test strip manufacturing process by 30%
  • Improve throughput in the reagent capper and the reagent filler by 40%
  • Improve throughput by 40% of the conjugates into tubes

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