Pine Lake Laboratories provides analytical services to pharmaceutical, biotech, and medical device clients. It aims to help clients develop innovative and safe new medicines and devices for patients. The company has expertise in analytical testing, extractables/leachables testing, bioanalysis, and combination product analysis. It manages projects through assigned group leaders and aims to be an integral research partner for its clients.

1. Pine Lake Laboratories
Kurt Moyer, Ph.D.
President

2. Mission Statement
• To be an integral research partner to our clients
to assist in bringing innovative, safe new
medicines and medical devices to patients in
need.

3. Company Overview
• PLL provides analytical solutions to the
pharmaceutical, biotech and medical device
industries.
• FDA registered and inspected with a proven
record of ensuring FDA compliance.
• Our areas of expertise include;
▫ Analytical CMC Support
▫ Extactables and Leachables Testing
▫ Analytical Analysis of Combination Products
▫ Bioanalysis

4. Company History
• Formed in 2000 as Pharmalytica Services in
Newington, CT
• Relocated to Bristol, CT in 2010
• Acquired by NSF International in 2011
• Operated as NSF Health Sciences.
• NSF Health Sciences announced withdrawl from
pharmaceutical testing in March 2017.
• Sold by NSF International to form Pine Lake
Laboratories in January 2018.

5. Leadership Team
Kurt L. Moyer, Ph.D. – President
• Dr. Moyer joined Pharmalytica Services in 2006.
• Was responsible for all technical operations and since
Oct16 financial performance.
• Purchased the laboratory from NSF in January 2018.
• Prior to joining NSF Health Sciences, served as a Senior
Research Investigator at Sanofi Aventis (5 years)
• Before Sanofi Aventis worked as a Research Scientist for
the DuPont Merck who was acquired by BMS (11 Years)
• Dr. Moyer holds a Ph.D. in Biochemistry from Villanova
University and a BS in Biochemistry from Millersville
State University.

6. Leadership Team
Ulyana Matyugicheva, M.S. – Group Leader
M.S. Chemistry-Kazan State University
Ulyana has been with the laboratory for over 11 years
Casandra Tellarini, B.S. – Group Leader
B.S. Chemistry-Western New England College
Casandra has been with the laboratory for over 11 years
Kevin Webb, B.B.A. – General Manager
B.B.A. Business Management from Western Michigan University
Kevin has been with the laboratory for over 10 years
Richard C. Wedlich, M.S. - Director, Quality
Assurance
MS Physical Chemistry-Marquette University
Formerly with Lockheed (NASA), Arch Chemical and Schering-Plough

8. GLP Analytical Services
• Development & Validation of Methods for
Dosing Solution Analysis
• Toxicology and PK Study Support
• Evaluate stability, homogeneity and
compatibility of dosing solutions
• Test Article Characterization
• Wide Experience with Formulation Types
Including Solutions, Suspensions and Drug
Delivery Systems

9. GMP Analytical Services
• Develop methods for purity/assay and related
substances/degradation products by HPLC
• Validation Following ICH Guidance
• Residual solvents by GC-FID (USP <467>)
• Elemental Impurities by ICP-MS (USP<233>)
• Identification of unknown process
impurities/degradation products by UPLC-QToF
• Compatibility testing with drug delivery systems
• Stability Testing & Coordinate Storage (3rd party)
• Product Release Testing
• Raw Materials, Clinical Supply and Excipient
Release Testing

10. Analytical Instruments
• HPLC
▫ Detectors: UV, CAD, FD and RI
• GC
▫ Detectors: FID, MS and NCD
▫ Headspace and direct inject
• ICP/MS
• UPLC-QToF
• UPLC/MS/MS
• UV-Vis
• FTIR

11. Analytical Experience
• Experience with analytical testing on the
following dosage forms:
▫ Oral
▫ Parenteral
▫ Nasal
▫ Liposomal drug products
▫ Ophthalmic
▫ Topical
▫ Transdermal

13. Extractables and Leachables
• Extensive experience with pharmaceutical
container closures and single use system
components.
• Extraction studies based upon PQRI guidances
for OINDP and PODP.

14. Extractables Analysis
 Headspace GC-MS for identification of volatile
organic extractables
 GC-MS for identification of semi-volatile organic
extractables
 LC-QToF for identification of non-volatile organic
extractables
 ICP-MS for identification of inorganic extractables
 Polynuclear Aromatic Hydrocarbon Screening (GC-
MS)
 Nitrosamine analysis by GC-NCD

15. Extractables Identification
 Use NIST for Volatile and Semi-Volatile Organic
Extractables
 Use ChemSpider for non-Volatile Organic
Extractables
 Proprietary Library
 Expert Interpretation based upon anticipated
extractables from material assessment

17. Combination Products
• A combination products combines
drug/device, biologic/device,
drug/biologic or all three

18. Types of Analytical Methods/Studies
for Combination Products
• Assay and related substances/degradation
products by HPLC-UV
• Residual process solvents by GC-FID
• Drug release/elution by HPLC-UV
• Uniformity of coating by HPLC-UV
• Extractables and leachables studies
• Identification of unknown process
impurities/degradation products by UPLC-QToF
• Compatibility of drug with device (co-packaged)

20. Bioanalytical Methods
 Small molecules and oligonucleotides
 Liquid-liquid extraction, solid phase extraction,
protein precipitation, digestion
 UPLC-MS/MS
 Ion exchange HPLC-UV (oligonucleotides)

21. Bioanalytical Matrices
 Fluid Plasma, blood, serum, synovial fluid, and urine
 Tissues: Liver, kidney, spleen, brain, spinal cord, heart,
eye, muscle, vaginal
 Species: Non-human primate, rodent, canine, porcine,
bovine and human

23. Project Management
• Client is assigned one of the Group
Leaders to be Principal Investigator (PI).
• PI is the single point of contact.
• PI is responsible for everything (e.g.
laboratory experiments, logistical
coordination, project management, etc.).
• PI schedules regular project meeting to
present and discuss progress.

24. Conclusion
• Our goal is to be an integral research partner to
our clients to assist in bringing innovative, safe
new medicines and medical devices to patients
in need.