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GMP Lab Capabilities

Cell-based Assays

Cell-based assays, or bioassays, are designed to measure the potency and stability of a drug substance or product and are important in establishing safety and efficacy profiles for biopharmaceuticals.

PPD Laboratories GMP lab has a 6,400-square-foot suite that is purpose-built and dedicated to bioassay development and testing. We work with customers to develop, transfer, optimize, qualify and validate potency assays that meet international regulatory and USP guidelines, in support of drug substance and drug product lot release and stability testing. Our lab can also create and maintain analytical cell banks for use in bioassay testing.

Our cell-based assay lab operations are led by doctorate-level cell biologists, averaging 20 years of experience developing and validating biological and immunological assays to support the development and commercialization of a range of biotherapeutic products and vaccines.

Our capabilities include:

  • Cell bank creation/qualification
  • Qualification of critical reagents
  • Method development/validation
  • GMP release and stability testing of drug substance and drug product
  • Statistical analysis (JMP, PLA)

Our methods include:

  • Cell proliferation and cytotoxicity
  • Cytokine and metabolite effector phosphorylation
  • Enzyme function assays
  • Reporter gene assays
  • Transfection/infection efficiency
  • Binding
  • Protein expression

Key instrumentation:

  • Molecular Devices instrumentation: SpectraMax® M3, M5, M5e, Flexstation and I3 plate readers
  • Perkin Elmer® EnVision® XCite multi-mode plate reader
  • Biotek® Cytation 5 Cell Imaging Multi-Mode Reader
  • FACSCanto™ II dual laser with 3 laser lines (405, 488, 633)
  • Beckman Cytoflex with 3 laser lines (488, 638, 405)
  • MSD® SECTOR® 600
  • Digital microscopes
  • Applied Biosystems™ qPCR
  • ThermoFisher Scientific QuantStudio™ 7 Flex Real-Time qPCR
  • Bio-Rad QX200 Droplet Digital PCR
  • Proteinsimple Wes™ Western blotting
  • Vi-CELL® Counter
  • Tecan® FreedomEVO® 150 liquid handler
  • JMP®, StatLIA®, PLA (Stegmann) software

Extractables and Leachables

The dedicated and highly specialized extractables and leachables (E&L) team in our GMP lab has more than 15 years of experience providing wide-ranging support for E&L studies, including overall study design/consulting, container/closure selection and manufacturing process qualification and validation. Our E&L team and toxicology experts work with you to make informed decisions on which extractable compounds will be monitored as leachables in long-term stability studies, development of extractable and leachable methods, leachable stability testing, batch extractables testing and USP compendia testing support.

Our lab employees belong to various industry groups, participate in E&L conferences and are regular contributors to industry publications on E&L. Our extensive experience designing and conducting E&L studies across a range of container/closure and device materials and across nearly all routes of administration has positioned PPD Laboratories as a leading industry expert in this highly technical field.

PPD Laboratories can deliver an integrated toxicity/safety evaluation by experienced and American Board of Toxicology-certified toxicologists familiar with the application of Product Quality Research Institute (PQRI) and other industry recommendations.

Material evaluation expertise:

  • A wide variety of parenteral product components including devices and containers/closures
  • Inhalation devices for delivery to lung and nasal mucosa:
    • Dry powder inhalers (DPI)
    • Pressurized metered-dose inhalers (pMDI)
    • Nasal spray solution/suspension bottles and pumps
  • Materials types, product dosage forms and routes of administration:
    • Transdermal products
    • Oral products
    • Labeling
    • Adhesives
  • Medical devices including implantables
  • Primary and secondary packaging and manufacturing components
  • Special case compounds:
    • N-nitrosamines
    • Mercaptobenzothiazole (MBT)
    • Polyaromatic hydrocarbons (PAH)
    • Other genotoxic impurities

Our services:

  • Controlled extraction study (CES) for material profiling
  • Leachable studies
  • Unknown leachable identification
  • Extractable profile and toxicological assessment
  • Silicone oil testing

Key instrumentation:

  • Liquid chromatography/mass spectrometry (LC/MS):
    • AB SCIEX TripleTOF™ 5600
    • Agilent 6545 QTOF
    • Other vendor platforms and models of single- and triple-quad LC/MS systems
  • Gas chromatography/mass spectrometry (GC/MS):
    • Multiple single-quad GC/MS systems with headspace, direct injection and prep station capability
    • Agilent 7890B / 5977 A/B MSD and other models Inductively coupled plasma mass spectrometry
  • (ICP-MS):
    • Multiple inductively coupled plasma-optical emission spectrometry (ICP-OES) and mass spectrometry (MS) systems of various models and vendor platforms
  • Dedicated lab areas for material extraction, preparation and analysis
  • Stable Micro Systems texture analyzer model TA.XTplusC
GMP Lab

Mass Spectrometry and Structural Elucidation

The mass spectrometry (MS) team in the PPD Laboratories GMP lab works closely with our method development and stability areas to identify critical degradation products that emerge over the course of the development cycle.

We use advanced instrumentation to identify and characterize active components as well as process impurities during the early phases of development for small and large molecules.

To enable the analysis of compounds not compatible with traditional LC-MS, we have developed two-dimensional liquid chromatography mass spectrometry (2D-LC/MS) methodologies for online separation and detection of compounds.

Our service offering includes:

  • LC-MS method development and validation of small molecules and large biomolecules, e.g. oligonucleotides, proteins, and monoclonal antibodies
  • Characterization of active pharmaceutical ingredients (APIs), products, reference standards and other pharmaceutical ingredients
  • Quantitative analysis of APIs, drug products, impurities using LC-UV/MS (single quadrupole or triple quadrupole mass spectrometers)
  • Impurity and degradation product identification and structural elucidation using high resolution mass spectrometry
  • Accurate mass determination for small molecules
  • Molecular weight determination for large biomolecules
  • High resolution mass spectrometry since we can use both Orbitrap and ToF MS
  • Sequence confirmation for oligonucleotides

Key instrumentation:

  • Thermo Scientific™ Q Exactive™ Plus with BioPharma Option mass spectrometer coupled with Vanquish UHPLC
  • Obtrap Exploris™ 240 with BioPharma Option mass spectrometer coupled with Vanquish UHPLC
  • Waters BioAccord LC-MS system
  • Waters QDa detector coupled with ultra-high performance liquid chromatography (ACQUITY UPLC H-class Bio System)
  • Waters ACQUITY® TQ Detector LC-MS/MS coupled with UPLC
  • AB Sciex 5600+ Triple TOF (MS) coupled with 2D-UHPLC
  • Applied Biosystems/MDS Sciex QTRAP® LC-MS/MS
  • Applied Biosystems/MDS Sciex API LC-MS/MS
  • Agilent single Quadrupole LC-MS
GMP Lab

Microbiology

PPD Laboratories GMP lab provides a wide range of microbiological testing. All tests are performed under GMP requirements and comply with applicable compendia (USP/EP/JP) requirements. We also accommodate specialty testing and projects of various sizes to suit a particular need. Our facility includes a 5,000-square-foot HEPA-filtered, restricted-access microbiology lab with a separate ISO Class 8 sterility suite.

Key instrumentation:

  • Seven ISO class 5 biosafety cabinets
  • A variety of incubators with 24/7 monitoring
  • Walker Barrier Systems Half-suit Isolator
  • Two Bioquell Qube sterility testing isolators
  • PTI VeriPac 445 Micro Leak Detection System
  • LIGHTHOUSE FMS-Oxygen Headspace Analyzer
  • Two ProtoCOL SR zone readers
  • Charles River EndoScan-V™

Our service offering includes:

Compendial USP/EP/JP Microbiology Testing

  • Sterility Testing
  • Microbial Limits
  • Bioburden
  • Antimicrobial Efficacy Testing
  • Bacterial Endotoxin Testing
    • Kinetic Chromogenic
    • Kinetic Turbidimetric
    • Gel Clot
  • Water Activity
  • Dye Ingress – Qualitative probabilistic
  • Laser based Oxygen Headspace Analysis – Quantitative Deterministic
  • Vacuum Decay – Quantitative Deterministic

Water Testing

  • Total Plate Count
  • Total Organic Carbon
  • Conductivity
  • pH

Specialized Microbiology Studies

  • Intravenous (IV) Microbial Challenge Hold Time Studies
  • Bacteriophage Plaque Assay
  • Low Endotoxin Recovery (LER) Studies
  • Antibiotic Potency Assay
  • Disinfectant Efficacy Studies

Product Type Experience

  • Sterile injectable products
  • Inhaled pharmaceuticals
  • Oral and topical pharmaceuticals
  • Over-the-counter (OTC) and consumer products
  • Raw materials and active pharmaceutical ingredients (APIs)

Physicochemical Material Characterization

PPD Laboratories GMP lab provides a complete selection of physical and chemical characterization technologies to support customers’ drug development programs. Our services support active pharmaceutical ingredient (API) analytical profiling, drug product preformulation and formulation development programs.

Our experts can develop methods and help customers design a comprehensive program that will proactively address full characterization of a variety of materials. In addition, these services can be combined with other analytical techniques to help you solve problems observed in the later phases of the drug development process.

A lab test

Our service offering includes:

  • Solution properties – dissociation equilibrium (pKa), partition/distribution-coefficient (Log P/D), solubility, zeta potential, viscosity, density, etc.
  • Particulate enumeration using the Beckman HIAC liquid particle counter or the ProteinSimple MFI™ system
  • Salt and polymorph form screening and selection
  • Melting point, enthalpy, polymorph and phase transition determination by differential scanning calorimetry thermal analysis (DSC), thermal gravimetric analysis (TGA) or X-ray powder diffraction (XRPD)
  • Water content, activity and hygroscopicity
  • Particle-size analysis (laser diffraction, dynamic light scatter, optical
  • Material and excipient compatibility studies
  • Other assays including refractive index, total organic carbon and FTIR

Key instrumentation:

  • Industry standard equipment available for all testing per USP and EP recommendations and regulatory requirements

stability 

We provide a full complement of GMP analytical testing resources and expertise to support development as well as commercial stability studies for APIs and drug products in virtually all dosage forms and delivery systems. Whether your program requires stability studies that follow the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) or you need a customized program, our experts can help. We’ll work closely with you to design a program that meets your requirements.

Our service offering includes:

  • ICH and customized testing for stability programs for APIs and finished product for small molecules and biologics in any dosage form/device/delivery system
  • Drug Enforcement Agency (DEA)-compliant stability programs
  • Photostability studies
  • Temperature cycling, freeze-thaw and shipping studies
  • Excipient and prototype formulation stability testing
  • Evaluation of stability data using ICH Guideline Q1E

Key instrumentation and facilities:

  • ICH- and DEA-compliant facilities
  • More than 100,000 cubic feet of walk-in and reach-in stability storage space at two geographic locations with space for an additional 75,000 sq. ft. of storage chambers
  • Customized electronic sample tracking tool monitored by computerized alarm system
  • Chamber condition limit alarm with automatic telephone call-out to staff (24/7)
  • Full generator backup
  • Standard chamber conditions range from -80°C to 50°C with 15% to 75% relative humidity (RH)
  • Customized temperature and relative humidity conditions can be accommodated upon request
  • Photostability chamber with white (visible) and near UV (UV-A) exposure options

Explore our GMP lab in Middleton, Wisconsin

Related Resources

Learn more about PPD Laboratories’ GMP lab capabilities.