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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 clients 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.

gmp instrumentation Our service offering includes:

  • Ligand binding with multiple assay and signaling formats
  • Cell migration/proliferation/cytotoxicity, including apoptosis, antibody and complement dependent cytotoxicity assays
  • Cytokine/metabolite phosphorylation and production
  • Transfection/transduction efficiency
  • Reporter gene assays

Key instrumentation:

  • State-of-the-art, purpose-built, environmentally controlled cell labs in Middleton and Athlone
  • Biosafety cabinets
  • CO2 incubators
  • Temperature controlled centrifuges
  • SpectroMax® M5 plate reader from Molecular Devices
  • BD FACSCanto II
  • Beckman Coulter Vi-CELL automatic cell counter
  • MSD® plate reader

Extractables and Leachables

The dedicated and highly specialized extractables and leachables (E&L) team in the PPD® Laboratories GMP lab has more than 15 years of experience providing full-program support for all aspects of E&L studies, including overall study design/consulting, container/closure selection as well as manufacturing process qualification and validation. Our E&L team and toxicology experts work with clients 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.

The employees of the GMP lab belong to various industry groups, participate in E&L conferences and are regular contributors to industry publications about 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.

Our extensive experience includes:

  • Container/closure and manufacturing components for a range of product types, including biopharmaceutical and biologic drug products
  • Pressurized metered dose inhalers (pMDIs) and dry powder inhalers (DPIs)
  • Nasal spray solutions and suspensions
  • Injectables including syringes, vials, devices, intravenous (IV) bags and administration sets
  • Lyophilized products
  • Ophthalmic drug products
  • A variety of disposable, single-use materials used in bioprocess manufacturing, such as filters/filter housing, fill tubing, intermediate storage bag films and valve components.
  • A variety of other container closure materials including labels, foils, adhesives, films, gaskets and caps

gmp extractablesOur service offering includes:

  • Material and process qualification and validation for in-process manufacturing
  • Controlled extraction studies with LC-MS, GC-MS direct injection, GC-MS headspace injection sample analyses and ICP-MS with data interpretation and toxicity assessment services
  • Leachable and extractable method development and validation studies
  • Material qualification for polynuclear aromatic hydrocarbons (PAH), N-nitrosamines and other special case or genotoxic compounds by LC-MS/MS or GC-MS
  • Leachables monitoring for stability studies and routine extractables testing

Key instrumentation:

  • Agilent GC-MS
  • Waters LC-MS/DAD (diode-array detector)
  • Sciex LC-MS/DAD and Q-ToF LC/MS capabilities
  • Agilent, Thermo Scientific and Perkin Elmer® Inductively Coupled Plasma Mass Spectrometry Optical Emission Spectroscopy (ICP-MS and ICP-OES)
  • Soxhlet and reflux extraction
  • Microwave-assisted extraction and accelerated solvent extraction

Mass Spectrometry and Structural Elucidation

The mass spectometry (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.

gmp massOur service offering includes:

  • LC-MS method development and validation of small molecules and large biomolecules, e.g. oligonucleotides, proteins, and monoclonal antibodies
  • Characterization of 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
  • Peptide mapping by quadrupole time-of-flight (Q-ToF) mass spectrometry
  • Sequence confirmation for oligonucleotides

Key instrumentation:

  • Waters Q-Tof Premier® mass spectrometer (MS) coupled with high performance liquid chromatography (HPLC or UPLC)
  • Waters Synapt G2-Tof® MS coupled with two dimensional ultra-high performance liquid chromatography (2D-UPLC)
  • 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

Microbiology

PPD® Laboratories GMP lab provides a full 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 state-of-the-art facility includes a 5,000-square-foot HEPA-filtered, restricted access microbiology lab with a separate ISO Class 8 sterility suite.

MicrobiologyOur service offering includes:

  • Endotoxin testing (kinetic turbidimetric, chromogenic and gel clot)
  • Microbial limits testing (per USP <61> <62>)
  • Bioburden testing
  • Water activity
  • Conductivity
  • Total organic carbon
  • Antimicrobial effectiveness (per USP <51>)
  • Antibiotic potency assay (per USP <81> or develop method)
  • Container closure integrity testing via dye ingress and/or oxygen headspace (per USP <1207>)
  • Sterility testing (performed in an isolator per USP <71>)
  • Minimum inhibitory concentration (MIC)
  • Intravenous (IV) solution microbial challenge studies

Key instrumentation:

  • HEPA-filtered, restricted access microbiology lab
  • ISO Class 8 sterility suite
  • ProtoCOL SR zone reader
  • LIGHTHOUSE oxygen headspace analyzer

Physicochemical Material Characterization

PPD® Laboratories GMP lab provides a complete selection of physical and chemical characterization technologies to support our clients' 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 clients 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 clients solve problems observed in the later phases of the drug development process.

PhysicochemicalOur 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
  • Others assays including refractive index, total organic carbon, 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 state-of-the-art GMP analytical testing resources and expertise to support development as well as commercial stability studies for active pharmaceutical ingredients 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 all of your requirements.

StabilityOur service offering includes:

  • ICH and customized testing for stability programs for API 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 square feet 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

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