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.
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:
Nucleotides/oligonucleotides; siRNA, synthetic oligonucleotides, PEGylated oligonucleotides, DNAi and RNAi
DNA, mRNA, plasmids and viral gene therapy products
Carbohydrates and polysaccharides
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
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 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
PPD Laboratories has experience with more than 60 cell and gene therapies.
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.
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)
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
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
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
Novel drug delivery systems
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
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)
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
Leveraging more than 20 years of experience to develop robust methods for all manner of pharmaceutical products.
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
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