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cGMP Analytical Services
PPD cGMP laboratory has extensive analytical expertise, allowing us to offer clients a diverse set of services, including:
Analytical Development
PPD's cGMP labs perform analytical methods development and validation for a wide range of pharmaceutical compounds and dosage forms during various drug development stages, including methods for:
- A wide range of chromatography techniques (HPLC, GC, SEC and IC) and detection technologies (UV, FL, MS, ELSD, RI, FID, TCD, MALLS, etc.) to meet the requirements for different types of compounds
- Stability-indicating assay and/or related substances methods for drug substance
- Stability-indicating assay and/or related substances methods for drug product (tablet, capsule, suspension, cream, injectable, nasal spray, MDI, medicated feed, drug eluting stent, etc.)
- Dissolution (IR, ER, MR)
- Organic volatile impurities
- Preservatives & antioxidants
- Enantiomeric separation
- Clinical comparator assay and dissolution
- Cleaning validation on various surfaces by HPLC, TOC and GC
- Dose verification for GLP studies
Other capabilities of the analytical development group include:
- Method development experimental design
- Interim progress reports for method development
- Method validation protocol development and preparation
- Gap analyses and remedial method validation
- Customized method validation reports
Analytical Testing Services
PPD analytical testing services have the capability to evaluate the following dosage forms:
- Tablets
- Capsules
- Liquids
- Suspensions
- Lyophilized powders
- Injectables
- Others
Services offered in this area include:
- Method optimization, qualification, validation and transfer
- Release and in-process testing
- Expedited services available
- Stability protocol development and program management
- Stability storage and testing
- Stability data trending
- Physical chemistry testing
- Compendial testing
- Microbiological testing
- Analytical support for cleaning and process validation
- Analytical support for formulation development
- Compatibility studies
- Reference standard characterization
- Materials characterization
- Thermal analyses
- Particle size characterization
- Microscopy
- Spectroscopy (FTIR, LC-MS, GC-MS, etc)
PPD has a wide range of general laboratory instrumentation (Adobe Acrobat file, 217 Kb)
Extractables / Leachables
PPD provides full program analytical support for extractables / leachables studies. Our experience and capabilities in this area include:
- Experience in completing over 40 extractable/leachable studies
- Representation on the Product Quality Research Institute (PQRI) and approaches extractable/leachable studies per PQRI recommendation
- Experience with (but not limited to) pMDI, nasal spray solution/suspension, injectables in bags/vials, lyophilized product, stoppers, vials, syringes, bags, nasal spray pumps, labels, adhesives/inks, implantable devices, tubing, resin, film, caps, foil, e-flow device, gasket, and valves
- Controlled extraction studies with LC-MS, GC-MS direct injection and GC-MS headspace injection sample analyses with data interpretation and toxicity assessment services
- Leachables method development and validation studies
- Material qualification for polynuclear aromatic hydrocarbons (PAH), N- nitrosamines and other toxicologically concerned compounds
- Stability leachables testing and routine extractables testing
Structural Chemistry Services
Our cGMP laboratories also offer structural chemistry services for small and large molecules that include:
- Impurity and degradation product identification and structural elucidation
- Characterization of API, product, reference standard and other pharmaceutical ingredients
- Trace element analyses and quantitation
- Accurate mass determination for small molecules
- Molecular weight determination for large biomolecules
Our specialized instrumentation capabilities include a Waters Q-ToF Premier, several PE SCIEX API 3000’s and 2000’s, LC-MS, Aglient 6890 GC-MS and Thermo Elemental ICP-MS.
Inhalation Services
PPD inhalation services support testing for pulmonary and nasal products, including:
- Dry powder inhalers (DPI)
- Pressurized metered dose inhalers (pMDI)
- Nebulizers
- Aqueous nasal sprays
- Novel drug delivery systems
Analytical services offered for inhalation products include:
- Method development and optimization
- Method validation, qualification and transfer
- Stability, release and QC testing
- Appearance and color testing
- Dehydrated alcohol content
- Device counters
- Dose content uniformity
- Drug content assay
- Extractables/leachables
- Foreign particulate matter
- Identification
- Impurities and degradation products
- Leak rate
- Microscopic evaluation
- Net content or fill weight
- Particle size by laser diffraction
- Particle size distribution by impactors
- Plume geometry
- Preservatives
- Pressure
- Related substances methods
- Retention of prime
- Shot weight
- Spray pattern
- Spacer testing
- Stability-indicating assay
- Total number of actuations
- Valve delivery
- Formulation evaluation studies
- Drug product characterization studies (device robustness, dosing orientations, effect of resting times, and others)
PPD utilizes a wide variety of equipment for inhalation technologies.
Biopharmaceutical Services
PPD biopharmaceutical services include the analysis of small and large biomolecules, such as:
- Proteins
- Monoclonal and polyclonal antibodies
- Recombinant proteins
- Hormones
- PEGylated and glycosylated proteins
- Peptides/polypeptides
- Nucleotides/oligonucleotides
- DNA
- Carbohydrates/polysaccharides
Methods utilized include:
- Chromatography (HPLC, reverse phase, ion exchange, size exclusion)
- Electrophoresis (agarose, SDS-PAGE, IEF, CE, cIEF)
- Amino Acid Analysis
- Peptide mapping
- Protein sequence confirmation
- Mass spectroscopy, LC-MS/MS
- Disulfide bond linkage identification
- ELISA
- Activity assays
- Host cell protein and host cell DNA
Capabilities in this area include:
- Method development and validation
- Product characterization
- Stability testing and storage of API and finished product
- QC testing of API, in-process samples and finished products
- Release testing for clinical trial material and commercial product
- Pre-formulation support and formulation evaluation
- Coagulation analysis (PT, APTT, Antifactor Xa, IIa)
- Cell based assays
PPD utilizes biopharmaceutical technologies.
Medical Device Services
PPD analytical services for drug-loaded stents and medical implants include:
- Analytical method development and validation
- Clinical and commercial release testing
- Stability protocol design and testing
- Process development and validation support
- Product characterization including impurity identification, impurity profiling, extractable and leachable and polymeric matrix characterization
Analytical testing methods include:
- Assay/content uniformity
- Kinetic drug release/drug elution
- Impurity and degradation products
- Residual solvents
- Particulate matter (USP<788>)
- Sterility/bacterial endotoxin
- Pouch integrity and oxygen testing
- Percentage crystallinity by microscope analysis
Polymer characterization includes:
- Trace metal analysis by ICP-MS and AA
- Polydispersity, polymer molecular weight determination
- Polymer quantitation and polymer degradation products identification
- Monomer and un-reacted crosslinker quantitation
- Viscosity and thermal property characterization
- Functional group characterization by FT-IR
- Water sorption and desorption profiles
Microbiological Testing
PPD microbiological testing group includes the following capabilities:
- Microbial limits USP <61> <62>
- Endotoxin USP <85> and <151>
- Bioburden testing
- AntiMicrobial efficacy testing or preservative effectiveness testing USP <51>
- Water bioburden
- Minimum inhibitory concentration testing, NCCLS - M38-A
- Efficacy testing
- Identification of organisms: API
 - the API system is a simple, rapid and reliable bacterial identification system.
- Identification of organisms: Dupont Riboprinter system is a genetic based ID system that identifies organisms to specific varieties.
Lastly, PPD has extensive project management experience that can guide you throughout all the stages of a study, including:
- Project initiation: Includes project kick-off meeting to ensure clear understanding of project scope
- Timelines: Track project timelines and program milestones using Microsoft Project or other applicable project management tools
- Secure communications: Secure Web site connection available for presentation of technical data, project documents and other information per client request
- Document formatting and control: Dedicated technical writing and formatting group for producing consistently professional and submission-ready documents
- Project updates: Regular status reports and conference call discussions regarding project status and overall program direction and progress
- Product champion/project leader: Single point of contact for general client communications on all studies and programs that may cover multiple departments at PPD, which provides you with a clear communication path for obtaining answers to questions quickly and efficiently
- Problem resolution: Client is promptly notified of any issues and presented with well-conceived, viable options for resolving any problems
- Project budget: Regularly updated budget tracking to ensure project stays within budget expectations
- Metrics: Customized project performance and quality metrics are also available, if requested
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