Three Decades of Experience in
Protein Contract Research

Accreditation

In-House Quality Assurance Accreditation  for Kendrick Laboratories, Inc.

Kendrick Laboratories, Inc  is a Contract Research Organization specializing in protein analysis services. Mainly, we perform analytical 1D and 2D gel electrophoresis for food, biotech and pharmaceutical companies. Kendrick Labs is registered with the FDA through December 2023 (registration number FEI 3001238747)  and subject to regular FDA inspections.

A strong infrastructure of SOPs, developed and refined over many years, is maintained by QA personnel. A list of regulatory SOPs is provided below; credentials of QA personnel are provided on the following pages. Copies of our QA Manual and Accreditation Summary are available on demand.

Index – Standard Operating Procedures (SOPs)

G-SERIESGENERAL
G-1100Writing SOPs
G-1101Duties of the QA Manager
G-1102Quality Manual
G-1103QA Auditing of  SOP compliance
G-1104Investigation of Deviations
G-1105Data Checking and Control of Changes
G-1106Investigation of Out-of-Specification Results
G-1107Determining Rf Values for 1D and 2D Gels
G-1108Policy on SOP Deviation and Change Control
G-1109Corrective and Preventative Action (CAPA)
G-1110Distribution and archival of SOP’s
G-1112Vendor Selection and Qualification
G-1113Handling Complaints
G-1114Laboratory Notebook Procedures
G-1115Receipt of GLP/GMP Materials
G-1118Receipt Storage and Tracking of GLP/GMP Samples
G-1120Master Equipment List
G-1130Archival of GLP/GMP Raw data Calibration Records and Reports
G-1135Maintenance of GLP/GMP Data Integrity
G-1140Reporting of GLP results
G-1145GLP/GMP Orientation and Training Program for Employees
G-1200Adjustable Pipetter Calibration
G-1205Melles Griot Filter Calibration
G-1210Freezer Log and maintenance
G-1211Refrigerator Log and maintenance
G-1212Automatic Monitoring of Temperature in Refrigerators and Freezers
G-1220Balance Calibration
G-1230Thermometer Calibration
G-1231Data Logger Calibration
G-1240Timer Calibration
G-1245NIST Calibrated Ruler Use
G-1252ChroMate 4300 Microplate Reader Use and Calibration
G-1260Water System Meter Calibration and Maintenance
G-1270pH Meter Calibration
G-1276Power Supply Calibration
G-127883 Multimeter Calibration

In addition, Kendrick Labs has seven Protocol SOPs for in-house testing, fifteen Protocol SOPs custom written for various companies for the purpose of validating a method, and 105 Laboratory SOPs. Credentials of the Quality Assurance Personnel and the Lab Manager are below.

Curriculum Vitae of Quality Assurance Personnel

Christina Rose – Quality Assurance Manager

Education and Training:

  • B.S. in Anthropology and Zoology, University of Wisconsin-Madison (May, 2010)
  • Part time Lab Assistant at Kendrick Labs (2000 – 2001)
  • Part time 2D Analyst, (2001 – May 2010); part time QA Assistant (2009 – May 2010)
  • 2D Analyst, (June 2010 – present)
  • Quality Assurance Assistant, (June 2010 – Feb 2011)
  • Quality Assurance Associate (Feb. 2011 – Sept. 2016)
  • Senior Quality Assurance Associate, (Oct 2016- April 2018)
  • Quality Assurance Manager, (April 2018- Present)
  • Training Certification-Quality Assurance Checking of fish speciation reports (May, 2008)
  • Training Certification-Excel Spreadsheets (March, 2010)
  • Training Certification-Method Validation (July, 2010)
  • Training Certification-Quality Assurance Duties and Archiving (February, 2011)
  • Training Certification- Comparison of GCP, GLP, and GMP (June, 2014)
  • Training Certification- Rees Scientific Software and Alarm Response (August, 2016)
  • Training Certification- Checking for and Correcting data changes after SameSpots Applied (November, 2016)
  • Seminar: FDA Enforcement in 2017 (June, 2017)
  • Training Certification-CASSS Midwest Discussion Group: Challenges or Special Considerations When Developing ADCs and Bispecifics (June, 2017)
  • Training Certification-Receiving Materials
  • GLP/GMP Ongoing Training: complete through March, 2022

Nancy Kendrick – Senior Quality Assurance Associate, President/CEO

Education and Training:

  • B.S. in Biology, Chemistry minor, Illinois State University, Normal, IL (1967)  Ph.D. in Neurobiology, Washington University at St. Louis, MO (1973)
  • Postdoctoral fellowship at Washington University, Physiology Dept (1974-1976)
  • Postdoctoral fellowship at Univ. Wisconsin-Madison, Biochemistry Dept (1977-1981).
  • President of Kendrick Labs Inc. (1981-present), QA Manager (1997-2018), Sr QA Associate (2018-Present)
  • President of QuantiGel Corp, (software development company, 1986-1995)
  • Quality Regulations and Standards for Biotechnology: GMPs at MATC (Spring, 1999)
  • Training Certification: Excel Spreadsheets (March, 2010); Method Validation (July, 2010)
  • Training Certification: Comparison of GCP, GLP, and GMP (June, 2014)
  • Seminar: FDA Enforcement in 2017 (June, 2017)
  • Training Certification-CASSS Midwest Discussion Group: Challenges or Special Considerations When Developing ADCs and Bispecifics (June, 2017)
  • Wrote, supervised writing, or gave final approval to SOPs at Kendrick Labs, Inc
  • GLP/GMP Ongoing Training: complete through March, 2022

Societies

  • Member of AES, ASBMB, and AAAS
  • Councilor of American Electrophoresis Society (AES), 1996-1998
  • Vice President AES, 2000-2002;  President AES, 2002-2004

Abstracts for talks

Kendrick, N., Hoelter, M., Koll, A., Powers, G., and Johansen, J. ” Tyrosine phosphorylation of Src versus keratin proteins in human lung tumors” AES Annual Meeting, Nov 2016, San Francisco, CA

Kendrick, N., Hoelter, M., Koll, A., Powers, G., and Johansen, J. “Refinement of an Internal Standard for Phosphotyrosine Western Blotting” AES Annual Meeting, Nov 2016, San Francisco, CA

Kendrick, N., Hoelter, M., Koll, A., and Johansen, J. ” Preparation of a phosphotyrosinylated protein standard for 2D gel western blotting” AES Annual Meeting, Nov 2015, Salt Lake City, UT

Kendrick, N., Hoelter, M. and Johansen, J. “Identification of Receptor Tyrosine Kinases using Western blot image overlays from 2D gels.” AES 30th Annual Meeting, Nov 2013, San Francisco, CA

Johansen, J and Hoelter, M and Kendrick, N, “Optimization of 2D Gel Transblotting for HCP Antibody Analysis”, AES 26th Annual Meeting, Nov 2009, Nashville, TN

In addition, Dr. Kendrick has 29 publications, 3 white papers, and 22 abstracts from work in academia & business.

Isaac O’Malley-Laursen – Quality Assurance Associate

Education and Training:

  • B.S. in Biochemistry at the University of Wisconsin-Madison (May 2011)
  • Part time Laboratory Assistant at Kendrick Labs (Aug 2010 – May 2011)
  • Biochemist at Kendrick Labs (June 2011 – present)
  • Quality Assurance Assistant at Kendrick Labs (March 2013-April 2016)
  • Quality Assurance Associate at Kendrick Labs (April 2016-Present)
  • Senior 2D Analyst at Kendrick Labs (April 2016- Present)
  • Training Certification-Progenesis PG240 software and report writing (September, 2011)
  • Review of changed SOPs (February, 2011)
  • Training Certification-GMP analysis and reports (February, 2012)
  • Training Certification-1D Gel Loading (March, 2012)
  • Training Certification-Host Cell Protein Analysis (September, 2012)
  • Training Certification-Wet Gel Handling (February, 2013)
  • Training Certification-Quality Assurance Checking of Fish Speciation Reports (March, 2013)
  • Training Certification- Quality Assurance Duties and Archiving (November, 2014)
  • Training Certification- Comparison of GCP, GLP, and GMP (November, 2014)
  • Training Certification- Quality Assurance Checking of GMP Reports (July, 2015)
  • Training Certification- Rees Scientific Software and Alarm Response (August, 2016)
  • Training Certification- Checking for and Correcting data changes after SameSpots Applied (November, 2016)
  • Seminar: FDA Enforcement in 2017 (June, 2017)
  • GLP/GMP Ongoing Training: complete through March, 2022

Jon Johansen – Laboratory Manager

Education and Training:

  • B.S. in Biochemistry from University of Wisconsin-Madison (1985)
  • Biochemist at Kendrick Labs (1985-1992)
  • Laboratory Manager at Kendrick Labs 1992 – present
  • Wrote or supervised writing of most SOPs at Kendrick Labs, Inc
  • Training Certification-CASSS Midwest Discussion Group: Challenges or Special Considerations When Developing ADCs and Bispecifics (June, 2017)
  • GLP/GMP Ongoing Training: complete through March, 2022

Abstracts and Publications

Kendrick, N., Hoelter, M., Koll, A., Powers, G., and Johansen, J. ” Tyrosine phosphorylation of Src versus keratin proteins in human lung tumors” AES Annual Meeting, Nov 2016, San Francisco, CA

Kendrick, N., Hoelter, M., Koll, A., Powers, G., and Johansen, J. “Refinement of an Internal Standard for Phosphotyrosine Western Blotting” AES Annual Meeting, Nov 2016, San Francisco, CA

Kendrick, N., Hoelter, M., Koll, A., and Johansen, J. ” Preparation of a phosphotyrosinylated protein standard for 2D gel western blotting” AES Annual Meeting, Nov 2015, Salt Lake City, UT

Kendrick, N., Hoelter, M., Koll, A., and Johansen, J. ” Quantification of 2D Gel anti-pTyrosine Western Blots from Human Tumor Samples ” AES 31th Annual Meeting, Nov 2014, Atlanta, GA

Kendrick, N., Hoelter, M. and Johansen, J. “Identification of Receptor Tyrosine Kinases using Western blot image overlays from 2D gels.” AES 30th Annual Meeting, Nov 2013, San Francisco, CA

Johansen, J and Hoelter, M and Kendrick, N, “Optimization of 2D Gel Transblotting for HCP Antibody Analysis”, AES 26th Annual Meeting, Nov 2009, Nashville, TN

Kendrick, NC. Johansen, JJ, Lee, PR and Santek, DA. “Optimization of an HP Scanjet for Quantification of Protein Electrophoresis Gels” Anal. Biochem. 219: 297‐304, 1994

Burgess-Cassler, A, Johansen, J, Santek, D, Ide J and Kendrick N.  Computerized quantitative Analysis of Coomassie-Blue Stained Serum Proteins Separated by 2D Electrophoresis.  Clin. Chem. 35: 2297, 1989.

In addition, Jon has two publications, two white papers and 9 abstracts from work in academia and business.   

Matt Hoelter – Western Blot Manager, Senior Biochemist, 2D Analyst

Education and Training:

  • B.S. in Biochemistry from University of Wisconsin-Madison (May 2004)
  • Laboratory Assistant at Kendrick Labs (March 2002-May 2003)
  • Biochemist at Kendrick Labs (May 2004-April 2010)
  • 2D Analyst at Kendrick Labs (May 2004-present
  • Senior Biochemist (May 2010-present)
  • Western Blotting  Manager (May 2013 – present)
  • Training Certification-Quality Assurance for Fish Analyses for the FDA (August, 2006)
  • Training Certification-Silver staining (August, 2007)
  • Training Certification-2D Gel Loading (July, 2009)
  • Training Certification-Progenesis PG240 and SameSpots (February, 2013)
  • Training Certification-IEF Tube Gel Pouring and Extrusion (February, 2013)
  • Training Certification-Fish Sample Preparation for FDA reports (February, 2013)
  • Training Certification-Wet Gel Handling (February, 2013)
  • Training Certification-Rees Scientific Software and Alarm Response (August, 2016)
  • Training Certification-Checking for and Correcting data changes after SS Applied (Nov, 2016)
  • Training Certification-Receiving Materials (May, 2017)
  • Training Certification-CASSS Midwest Discussion Group: Challenges or Special Considerations When Developing ADCs and Bispecifics (June, 2017)
  • Training Certification-Receiving Samples (August, 2018)
    GLP/GMP Ongoing Training: complete through March, 2022
  • Executive Director of the American Electrophoresis Society 2006 – present

Abstracts and Publications

Kendrick, N., Hoelter, M., Koll, A., Powers, G., and Johansen, J. ” Tyrosine phosphorylation of Src versus keratin proteins in human lung tumors” AES Annual Meeting, Nov 2016, San Francisco, CA

Kendrick, N., Hoelter, M., Koll, A., Powers, G., and Johansen, J. “Refinement of an Internal Standard for Phosphotyrosine Western Blotting” AES Annual Meeting, Nov 2016, San Francisco, CA

Kendrick, N., Hoelter, M., Koll, A., and Johansen, J. ” Preparation of a phosphotyrosinylated protein standard for 2D gel western blotting” AES Annual Meeting, Nov 2015, Salt Lake City, UT

Kendrick, N., Hoelter, M., Koll, A., and Johansen, J. ” Quantification of 2D Gel anti-pTyrosine Western Blots from Human Tumor Samples ” AES 31th Annual Meeting, Nov 2014, Atlanta, GA

Kendrick, N., Hoelter, M. and Johansen, J. “Identification of Receptor Tyrosine Kinases using Western blot image overlays from 2D gels.” AES 30th Annual Meeting, Nov 2013, San Francisco, CA

Johansen, J and Hoelter, M and Kendrick, N, “Optimization of 2D Gel Transblotting for HCP Antibody Analysis”, AES 26th Annual Meeting, Nov 2009, Nashville, TN

In addition, Matt has two white papers and 12 abstracts.

Additional Trained Employees

In addition, Kendrick Labs employs a Senior Biochemist, two Associate Biochemists, three Biochemists, and a Lab Technician, all trained appropriately according to SOP G-1145.