PPD® Laboratories: Part of the COVID-19 Solution
WE ARE JOINING YOU IN THE FIGHT
COVID-19 has and will continue to impact our industry. We know our customers need a trusted laboratory partner to navigate critical studies through this time of uncertainty. Each of our laboratories is prepared to help bring COVID-19 therapies and vaccine programs to fruition with a set of capabilities and relevant experience that enables us to accelerate trials with high-quality services through all phases of development.
COVID-19 Drugs Currently
in Development that PPD
Laboratories’ has Experience
With
Non-proprietary Assays
Available to all Customers
Scientists and Staff
Committed to Being Part of
the COVID-19 Solution
WHERE YOU NEED US, WHEN YOU NEED US
PPD LABORATORIES HAS NEARLY 1 MILLION SQ. FT. OF LAB SPACE ACROSS THE GLOBE
VACCINE SCIENCES LAB
PPD Laboratories’ vaccine sciences lab is prepared and equipped to support your COVID-19 trials. We have developed fit-for-purpose assays to assess immunogenicity to SARS-CoV-2. Our vaccine sciences lab has experience across a wide variety of vaccines for respiratory pathogens.
Relevant capabilities
- Method development, qualification/validation and transfer
- Antigen detection, quantitative RT-PCR and sequencing
- Traditional and multiplex immunoassays
- Neutralization assays and viral and bacterial functional assays
- High-throughput testing capabilities
- Non-proprietary SARS-CoV-2 molecular and serology assays available
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- COVID-19 screening
- Vector shedding and viral load
- Immunogenicity studies
Relevant expertise
- 15 FDA-approved vaccine programs supported
- 25+ years supporting vaccine efficacy and immunogenicity programs
- 15+ years performing data analysis
- Extensive experience with multiplexed immunoassays
BIOANALYTICAL LAB
PPD Laboratories’ bioanalytical lab has the experience you need to accelerate COVID-19 therapeutics to market. Our research and development team is well-equipped to develop custom assays including pharmacokinetic, pharmacodynamic and immunogenicity methods across multiple assay types.
RELEVANT CAPABILITIES
Broad testing capabilities across multiple platforms and methodologies
- Immunochemistry
- Mass spectrometry
- Cell-based assays
- Flow cytometry
- Molecular genomics
RELEVANT EXPERTISE
- 25+ years working with small molecule, biologic and anti-viral drugs
- Deep expertise in method development, optimization, qualification, validation and transfer
- Broad exposure to a variety of regulatory environments and a strong history of collaboration with regulatory agencies
- Experience with 20+ therapeutics being assessed for COVID-19
“In response to the COVID-19 pandemic, we have created a cross-laboratory team of scientists from each of our five labs that meets multiple times a week to discuss our progress towards assays that will be used in vaccine, cell/gene therapy and therapeutic trials. We are collaborating across many different areas including molecular genomics, immunogenicity and biomarkers to ensure we will be ready when our customers need us.”
BIOMARKER LAB
PPD Laboratories’ biomarker lab is ready to provide fit-for-purpose PCR assays that determine vector shedding and viral load for COVID-19 programs. We have experience with custom assay development and transfer, as well as various methodologies.
Relevant capabilities
- Fit-for-purpose method development for exploratory biomarkers across a variety of technologies including:
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- Ligand-binding assays
- Liquid chromatography and mass spectrometry (LC-MS)
- Molecular genomics
- Transfer and cross-validate assays to different/multiple locations or under multiple regulatory requirements
Relevant expertise
- Guidance on right development approach and technology platforms to effectively integrate safety and efficacy biomarkers into your clinical development program
- Our leadership team has more than 50 years of combined industry experience
- Broad experience developing and validating methods under appropriate regulatory guidelines at each stage of drug development
- Deep experience navigating and overcoming regulatory uncertainties
CENTRAL LAB
PPD Laboratories’ central lab is equipped with a full test menu supported by innovative data solutions that allows our customers to make better and faster decisions throughout their COVID-19 trials.
Relevant capabilities
- Routine chemistry, immunoassay and safety testing
- Autoimmune and inflammatory
- Biostorage
- Cell-based assays and flow cytometry
- Genomics and molecular assays
- Coagulation testing
Relevant experience
- All required certifications across all locations (U.S., EU, Singapore and China)
- Innovative Preclarus® lab data solutions provide complete specimen chain of custody
- More than 10 years of integrating lab and clinical data
- Study startup in about 25 days
GMP Lab
PPD Laboratories’ GMP lab is ready to support your COVID-19 vaccines and therapies with significant experience, high-quality staff, significant global capacity and industry expertise.
RELEVANT CAPABILITIES
- Method development, validation and transfer under current good manufacturing practices (cGMP) regulations
- Physicochemical product characterization
- Identity/purity/potency analysis
- Quality control and release testing
- Microbiology services
- Product stability and storage
- Extractables and leachables program support
RELEVANT EXPERTISE
- More than 20 years’ working with small molecules, biologics, cell and gene therapies, and vaccines
- Extensive chemistry, manufacturing and controls (CMC) pharmaceutical development experience for innovator drugs, biologics, generics and biosimilars
- Broad exposure to a wide range of immunosuppressants and antivirals
- Support for manufacturing and cleaning validations
RELATED RESOURCES
Learn more about how PPD Laboratories can accelerate your COVID-19 trial with specialized lab services.
