Pace Analytical Life Sciences • 1311 Helmo Ave. N • Oakdale, MN 55128 P: 651.738.2728 • F: 651.714.9360 • www.pacelifesciences.com

BIOPHARMACEUTICALSPace Analytical Life Sciences (PLS) offers testing services to support the biopharmaceutical manufacturing industry. We provide chemistry and microbiology support for the development of new therapies and to ensure the quality of your marketed therapeutic proteins, synthetic peptides, enzymes, conjugates and specialty molecules. Our team of experts and our extensive selection of testing equipment offers you the services and expertise to support your biopharmaceutical development, commercialization, and release of marketed products.

Raw Materials Testing• Formulation Excipients• Active Pharmaceutical Ingredients (API)• Compendial Methods (USP / EP / JP)• Certificate of Analysis Verification• Vendor Qualification Program Support

Process Validation and Facility Monitoring Services

• Process Water Systems (Purified Water, WFI & Clean Steam)

• Compressed Air / Gas Systems• Cleaning Verification / Validation• On-site Sampling

Microbiology• Microbial Limits Testing (MLT)• Bioburden / Sterility• Particulate Matter• Bacterial Endotoxins• Disinfectant Efficacy Studies• Organism Identification

Finished Product and Packaged Goods• Enzymatic Activity• Charge Variant Analysis (Capillary)• Size Separations (Gel and Capillary

techniques)• Chromatography (Size Exclusion, Ion

Exchange, Reverse Phase)• Binding & Potency ELISA• Concentration Determination (UV-Vis

Variable Pathlength)• Impurities / Degradation Products• Quality Control Release Testing• Formulation Stability Testing• ICH Stability Storage

Research and Development• Method Development• Method Qualification• Method Validation• Method Transfer• Extractable / Leachable Studies• Container / Closure Tests• Elemental Impurities

(ICP-MS, ICP-OES, AA)

Our labs are cGMP-compliant, FDA registered, DEA registered

and ISO/IEC 17025:2005 accredited.

LIFE

SCI

ENCE

S | BI

OPH

ARM

ACEU

TICA

L TE

STIN

G

Locations

www.pacelifesciences.com

pace analytical life sciences puerto rico laboratory

EL RETIRO INDUSTRIAL ZONE P.O. BOX 325 / CALLE B&C SAN GERMAN, PR 00683 P: 787.892.2650 F: 787.892.1054

pace analytical life sciencesnew jersey laboratory

12 WORLDS FAIR DR SOMERSET, NJ 08873 P: 651.738.2728F: 651.714.9360

pace analytical life sciences minnesota laboratory

1311 HELMO AVE. N OAKDALE, MN 55128 P: 651.738.2728 F: 651.714.9360

wolfe laboratories a subsidiary of pace analytical life sciences

19 PRESIDENTIAL WAYWOBURN, MA 01801 P: 781.305.4940 F: 781.305.3780

Working Together to Protect Our Environment,and Improve Our Health.

Life Sciences_Biopharmaceutical Testing

Pace Analytical Life Sciences operates a network of four (4) locations to provide contract product development and laboratory testing services to the pharmaceutical, biopharmaceutical / biologics, and medical device industries. Our customers range from new and innovative start-up companies through to the veteran industry leaders. Our contract product development services help bring new therapies to market and our contract laboratory services to ensure the purity, potency, safety, efficacy, and shelf life of marketed products.

Laboratory Instruments - Biopharmaceutical Support

Microbiology Testing Equipment Manufacturer / ModelLiquid Particle Counting System • 2 HIAC Model 9703Image Analyzer / Microscope • 2 Fryer Image Analyzer / Nikon Eclipse E400,

Nikon Eclipse E600

Chromatography Manufacturer / ModelHPLCs: including UV/VIS, PDA, RI, and Fluorescence detection • 30

Agilent 1100, Agilent 1220, Waters Alliance

UPLC and UPLC-MS/MS • 7 Waters, Waters TQD, Waters H-ClassUPLC/MS-QTOF Waters H-Class UPLC w/Waters Xevo G2-XS Quadrupole

Time-of-Flight Mass Spec

Spectroscopy Manufacturer / ModelUV-Vis Spectrophotometer Beckman DU-800, Thermo Evolution 220UV-Vis, variable path length C Technologies, SoloVPE

ELISA Manufacturer / ModelMulti-mode Plate Reader Molecular Devices SpectraMax i3x

Gel Imaging Manufacturer / ModelSodium Dodecyl Sulfide Polyacrylamide Gel Electrophoresis (SDS Page)

Bio-Rad GS-900

Capillary Electrophoresis Manufacturer / ModelCapillary Electrophoresis Sodium Dodecyl Sulfide (CE-SDS) Protein Simple MauriceCapillary Isoelectric Focusing (cIEF) Protein Simple Maurice