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GMP Lab Experience and Expertise

Every test result is backed by more than 20 years of GMP experience and technical expertise

PPD® Laboratories’ GMP lab is committed to providing effective development services to meet the needs of the rapidly evolving pharmaceutical development regulatory landscape. Our GMP lab has offered client-site lab operations and management models to address challenges brought on by the evolution of the pharmaceutical development industry for more than 20 years. Our qualified scientists provide comprehensive method development, validation and quality-control testing services. We have experience working with all manner of pharmaceutical products and devices. Our expertise spans small molecules, biologics and cell and gene therapies.

BIOLOGICS

During past 20 years, PPD® Laboratories GMP lab has helped customers develop hundreds of biologic pharmaceuticals including more than 70% of the top 50 biologics of 2015 and eight out of the 10 best-selling biosimilars of 2014. Our expertise spans all phases of development — from feasibility to release testing for commercialized products.

OUR BIOLOGICS EXPERIENCE ENCOMPASSES A VARIETY OF MOLECULES:

  • Proteins; monoclonal and polyclonal antibodies, recombinant proteins, hormones, PEGylated proteins, glycosylated proteins, antibody-drug conjugates
  • Peptides and polypeptides
  • Nucleotides/oligonucleotides; siRNA, synthetic oligonucleotides, PEGylated oligonucleotides, DNAi and RNAi
  • DNA, mRNA, plasmids and viral gene therapy products
  • Carbohydrates and polysaccharides
  • Liposomes
  • Inhaled biologics
  • Process impurity assays; host cell protein, host cell DNA, iPTG, surfactants, antibiotics etc.

OUR BIOLOGICS SERVICES AND CAPABILITIES INCLUDE:

  • Feasibility, method development, qualification and validation
  • Product characterization
  • Forced degradation studies and analysis
  • Stability testing and storage of API and finished products
  • QC testing of API, in-process samples and finished products
  • Release testing for clinical trial material and commercial products
  • Pre-formulation support and formulation evaluation
  • Coagulation analysis (PT, APTT, Anti Xa, Anti IIa, etc.)
  • Cell-based assays

CELL AND GENE THERAPY

Cell and gene therapies are expected to grow at a rate of 1,000% in the next five years. PPD® Laboratories’ GMP lab has been working with these therapeutics for the past 15 years. Our team leverages more than 25 years of chemistry, manufacturing and control (CMC) experience to offer a comprehensive set of services specifically tailored to the needs of cell and gene therapy development programs.

Expertise in Cell and Gene Therapy

PPD Laboratories has been building its expertise with these complex development programs for nearly two decades and has worked with dozens of cell and gene therapies across a broad range of molecule types. Our expertise includes:

  • Specialized sample handling to minimize nucleases and moisture uptake for hygroscopic substances
  • Developing denaturing HPLC methods
  • Extensive work with complex formulation types
  • Separation methodologies and complete impurity analysis using multiple techniques
  • Transfer of custom-developed analytical techniques for a wide range of cell and gene therapy drug substances

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PPD Laboratories has experience with more than 60 cell and gene therapies.

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Years experience with cell and gene therapies

Cell and Gene Therapy Experience and Capabilities

Our wealth of experience with cell and gene therapies includes a variety of drug substances, many different study types and extensive experience with oligonucleotides. At PPD Laboratories, we are dedicated to supporting clients’ cell and gene therapy programs across the phases of drug development.

Drug substances

  • Oligonucleotides, including siRNA, RNAI and DNAI
  • Encapsulated and naked plasmids and mRNAs
  • Viral vectors including adenovirus vectors (AdVs), adeno-associated virus vectors (AAVs), baculoviral vectors (BVs) and lentivirus vectors (LVs)

Study types

  • Analytical method development and validation
  • Drug substance and reference standard characterization across a range of formulations and delivery routes
  • In-process sample analysis
  • Quality control and release testing
  • Stability testing and storage
  • Comparability studies
  • Forced-degradation studies
  • Process and formulation development support
  • Container/closure integrity testing (CCIT)

Extensive oligonucleotide capabilities and cGMP service offering

  • Full compliance with U.S. Food and Drug Administration (FDA) current good manufacturing practices (cGMP) regulations and rules governing medicinal products in the European Union
  • Customized method development, transfer and validation under cGMP
  • Full range of physiochemical and molecular characterization and potency assays
  • Bioburden and endotoxin testing
  • Safety testing

INHALED PHARMACEUTICALS

Developing medicines that are delivered via the pulmonary and nasal routes for the treatment of local and systemic diseases is challenging. While the demonstration of safety, potency and purity is a fundamental part of the marketing authorization process for all drugs, incorporation of a delivery device greatly increases the complexity of the drug development process.

PPD® Laboratories GMP lab has been supporting the respiratory community across the product development continuum for more than 18 years. We have depth of experience evaluating drug/device combinations, and see continued growth in novel combinations and multi-active medicinal products.

In the past 10 years we have supported the development of more than 100 inhaled products of which at least 10 have received approval for commercialization by regulatory bodies.

Breathe easier knowing you can rely on PPD Laboratories for your next inhaled pharmaceutical program.

Our experience with inhaled pharmaceuticals includes:

  • Dry powder inhalers (DPI)
  • Pressurized metered dose inhalers (pMDI)
  • Nebulizers UDV and MDV
  • Aqueous nasal sprays
  • Nasal aerosols
  • Novel drug delivery systems
  • Inhaled biologics

Analytical services offered for inhalation drug products include:

  • Formulation evaluation studies
  • Drug product characterization studies: device robustness, dosing orientations, effect of resting times and others
  • Wide-ranging extractables and leachables program support for container/closure systems
  • Drug content/stability assay development, optimization, validation, qualification and transfer
  • Stability, release and QC testing
  • Physicochemical characteristics for drug product and device
  • Dose content uniformity and emitted dose performance
  • Foreign particulate matter, impurities, degradation products and preservatives
  • Container/closure integrity including leak rate
  • Microscopic evaluation
  • Particle size, shape and distribution
  • Plume geometry and spray pattern

Key specialized facilities and instrumentation include:

  • Andersen cascade impactors
  • Clemex PS3 particle sizing system
  • Copley Scientific inhaler testing data analysis software (CITDAS), Model TPK critical-flow controller
  • HIAC Royco particulate matter analyzer
  • PPD-patented dose collection tubes used to analyze foreign particulate matter from pMDI and DPI products
  • Horiba particle-size analyzer
  • Humidity and temperature controlled testing rooms in Middleton and Athlone
  • Innova Systems nasal dose weight with collection station (NSP-DWC)
  • Malvern Spraytec droplet-size analyzer
  • Marple-Miller ImpactorM150
  • MDI FD-10 automated bursting station, nasal spray pump actuation station (Mighty Runt, NSP UA)
  • Multistage liquid impinger (MSLI)
  • Next generation impactors (NGI)
  • Optronics imaging system for optical microscopy
  • Pamasol hand crimper, vacuum crimper and pressure filler
  • SprayView® system for plume geometry and spray pattern
  • TSI digital flow meters

METHOD DEVELOPMENT AND VALIDATION

PPD Laboratories GMP lab performs method development and validation for a broad spectrum of biopharmaceuticals and dosage forms across all phases of pharmaceutical development. Our experienced scientists provide method development, experimental design, method validation protocol development, gap analyses, remedial method validation and customized method validation reports. In addition, we have a full complement of GMP analytical testing resources and expertise to perform release testing and quality control analyses for active pharmaceutical ingredients and drug products in virtually all dosage forms and delivery systems.

OUR SERVICE OFFERINGS INCLUDE:

  • Method development and validation for chromatography techniques including HPLC, UPLC, GC, SEC and IC with a variety of detection technologies including UV, DAD, FL, MS, ELSD, RI, PAD, FID, TCD, MALS, CAD
  • Method development and validation for stability-indicating assays and related substances methods for drug substance and drug products, such as, tablets, capsules, suspensions, creams, injectables, nasal sprays, pMDIs, DPIs, medicated feeds, drug-eluting stents
  • Method development, validation and quality control services for:
    • Dissolution (IR, ER, MR)
    • Organic volatile impurities
    • Preservatives and antioxidants
    • Clinical comparator assay and dissolution
  • Analytical support for process and cleaning validation on various surfaces by HPLC, UPLC, TOC and GC
  • Dose verification for GLP studies
  • Bioequivalency, in vitro pharmaceutical equivalency testing
  • Quality control support for
    • Dosing solution analysis for toxicology studies
    • Customer product complaint testing
    • Field monitoring testing
    • Generation of statistical quality control charts
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Leveraging more than 20 years of experience to develop robust methods for all manner of pharmaceutical products.

Learn more about our GMP lab

SMALL MOLECULES

PPD Laboratories GMP lab provides comprehensive analytical testing support for active pharmaceutical ingredients (API), intermediates, raw materials, in-process samples and finished products for all dosage forms of small molecules across all phases of drug development. PPD Laboratories has a customizable approach to all small molecule drug development programs. Support for a variety of methodologies ranges from phase appropriate analytical method development and validation to transfer of existing assays.

PPD Laboratories has broad experience and deep expertise with small molecule compounds.

GMP small molecule SERVICES AND CAPABILITIES INCLUDE, BUT ARE NOT LIMITED TO:

  • Customizable stability program design and management
  • Dissolution support (including USP Apparatus IV)
  • Physical characterization analysis
  • Release and QC testing
  • CMC consulting
  • Ability to support controlled substances, highly potent/toxic compounds, antibiotics and radioactive compounds
  • Photostability, freeze/thaw, excursion and cycling studies
  • Dosing solution analysis
  • Specialized lab teams to support dissolution, gas chromatography (GC), physical and compendial testing
  • Reference standard management

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