Life
Sciences

EKF Life Sciences

EKF Life Sciences manufactures diagnostic enzymes and contracted custom products for use in medical diagnostics, pharmaceuticals and industry.

EKF Life Sciences is based in Elkhart, Indiana and utilizes bacterial fermentation and downstream processes to isolate and deliver the highest quality enzymes and biomolecules specially engineered to our customers' specifications. 

The fermentation facility is designed to produce micro-organisms including recombinant organisms for the manufacture of post-fermentation products such as enzymes, proteins and related biomaterials.

Our 21,000 sq.ft. manufacturing facility is ISO 13485:2003 certified with 12,000 square feet dedicated to fermentation production activities.  

The plant routinely operates two segregated HEPA filtered fermentation suites with production vessels ranging from 80 liters to 1,600 liters. .

In addition, downstream processing equipment includes two AS-16 Super Sharples centrifuges located in a clean, HEPA filtered processing suite, a microfiltration unit for cell harvesting, two cell homogenizers, two freeze drying units for product processing and liquid nitrogen storage for cell banking.

 


Products and services

cta-life-sciences

Quality Assurance

EKF Life Sciences is committed to the development, manufacture, and delivery of quality products that meet or exceed customer expectations that are in accordance with FDA regulations and ISO13485:2003 Standards (Medical Devices). 

We are currently certified for ISO13485:2003 by DEKRA Certification B.V. and have a successful inspection track record since our initial certification to ISO9001:1994 back in 1998.

EKF Life Sciences is also audited regularly by customers from various industries, and we work with them to meet their specific quality system requirements.

Quality Assurance responsibilities include:

  • Finished product disposition
  • Customer and regulatory audits
  • Internal audits       
  • Deviation and CAPA systems
  • Vendor qualification
  • Change control
  • Training systems
  • Document control

Our commitment to you

Our team of experts work with early stage and mature processes to manufacture to ISO standards, and are committed to maintaining  these standards as well as unparalleled  customer service.

The EKF Life Sciences leadership team has decades of experience and a proven track record in delivering the highest quality of custom enzymes and related biomaterials.

EKF Life Sciences has been manufacturing enzymes and related biomolecules from bacterial fermentation since 1983.  

 

 

30 years of service

EKF Life Sciences has been manufacturing enzymes and related biomolecules from bacterial fermentation for use in IVD since 1983.  

Since then it has developed core competencies in technology transfer to commercialization, and the scale up of fermentation processes from bench top vessels to manufacturing large scale stable and reliable enzymes.  These enzymes can be consistently produced in bulk scale for mass production of test kits. 

With the continued development of microbial expression platforms and the expanding interest in medical and industrial applications for biologically produced intermediates and products, EKF Life Sciences serves as a critical link in the evolution of improved and  environmentally sensitive manufacturing processes.