GMP Lab Experience and Expertise

Our Solutions PPD Laboratory Services GMP Lab GMP Experience and Expertise

More than 20 years of GMP experience and technical expertise

PPD™ Laboratory services’ Good Manufacturing Practice (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

For more than 20 years, PPD Laboratory services’ GMP lab has helped clients develop hundreds of biologic pharmaceuticals including most of the top biologics and best-selling biosimilars.

Our biologics experience encompasses a variety of molecules:

Proteins: recombinant, PEGylated and glycosylated
Monoclonal and polyclonal antibodies
Antibody-drug conjugates (ADCs)
Hormones
Peptides and polypeptides
Nucleotides and oligonucleotides: siRNA, DNA, mRNA, DNAi and RNAi, synthetic and PEGylated
Cell and gene therapy products including oligonucleotides, messenger RNAs, plasmids and viral-vectored products
Carbohydrates and polysaccharides
Liposomes
Inhaled biologics
Process impurity assays: host cell protein and DNA, isopropyl ß-D-1-thiogalactopyranoside (IPTG), surfactants and antibiotics
Cell-based therapeutics

Our biologics services and capabilities include:

Product characterization

Product characteristic

Primary Structure
Secondary Structure
Tertiary Structure
Other Attributes

Assay capabilities

Amino acid composition by U/HPLC-UV, LC-MS (intact mass/peptide mapping/PTM analysis)
Free thiols, FTIR, CD (far UV)
CD (near UV), nano-DSC, IF
SEC-MALS, AUC, SPR, absorptivity coefficient

Release and stability

Product characteristic

Identity
Purity
Potency
Physical/Chemical Properties
Safety/Impurities
Safety – Microbiology
Inactive Ingredients
Drug Product Packaging

Assay capabilities

ELISA, Peptide mapping (UV, MS), intact MS
SEC, RP-, IEX-HPLC, HIC/HILIC, CE, iCE, SDS-PAGE
ELISA, enzyme kinetics, cell-based assays, SPR, MSD
Concentration (UV/Vis, slope ratio, micro BCA), turbidity, colorimetry, pH, osmolality, moisture, liquid and aerodynamic particle size
Residual host cell DNA by q/ddPCR, residual host cell proteins by ELISA, residual process impurities by ELISA, visible and subvisible particulates by HIAC, MFI and microscopy
Sterility (filtration), CCIT (vacuum decay, O2 headspace, dye ingress), endotoxins, bioburden, adventitious contamination testing
Surfactants by CAD and ELSD, ion chromatography, HPLC-RI
Break-loose force, glide force, next-generation impactor/Anderson cascade impactor

Extractables and leachables

Product characteristic

Container/Closure Compatibility
Single-Use Manufacturing Process Components Evaluation

Cell and gene therapy

Cell and gene therapies are expected to grow at a rate of 1,000% in the next five years. PPD Laboratory services’ GMP lab has been working with these therapeutics for the past 15 years. Our team leverages more than 25 years of chemistry, manufacturing and controls (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

We have been building expertise with these complex development programs for nearly two decades and have 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 high-performance liquid chromatography (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 Laboratory services 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 Laboratory Services, we are dedicated to supporting clients’ cell and gene therapy programs across the phases of drug development.

Drug substances experience

Oligonucleotides including siRNA, RNAi and DNAi
Encapsulated and naked plasmids and mRNAs
Viral vectors including adenovirus vectors (AdVs), adeno-associated virus vectors (AAV), baculoviral vectors (BVs), and lentivirus vectors (LVs)
Cell-based therapeutics, including modified stem, blood and immune cells, and CRISPR/Cas9

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

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)

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 Laboratory services’ 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.

You can rely on PPD Laboratory services for your next inhaled pharmaceutical program.

Our experience with inhaled pharmaceuticals includes:

Pressurized metered-dose inhalers (pMDI)
Dry powder inhalers (DPI) and devices
Aqueous and dry powder nasal sprays
Nasal aerosols
Nebulizers, solutions and suspensions
Novel delivery systems

Key instrumentation:

MSP Corp Next Generation pharmaceutical impactor
Andersen-type cascade impactors
Proveris Verio™ automated actuation stations
Proveris SprayVIEW™ Measurement System
Malvern Spraytec
Copley Breathing Simulator BRS-2100
Patented collection tubes to perform for assessment of foreign particulate matter (FPM) ex-device
Innova Systems nasal spray pump actuation stations and MDI FD-10 automated waste stations

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

Method development and validation

PPD Laboratory services’ 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

Explore our capabilities

Small molecules

PPD Laboratory services’ 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. We have 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 Laboratory services has broad experience and deep expertise with small molecule compounds.

Diverse methodologies and analysis support

Stability-indicating assay and/or related substances methods for active pharmaceutical ingredient and drug product
Clinical comparator and drug safety assays
Aerosol device characterization methods
Device functionality testing
Cleaning validations on various surfaces in support of manufacturing processes
Metals analysis
Methods for excipients, residual solvents, process impurities, preservatives and residual compounds
Physical and chemical characterization
Impurity characterization and identification
Extractables and leachables (E&L) full program support and consulting
Bioequivalence analytical support
In-use, freeze-thaw, shipping study design and management
ICH stability support