Vaccine CMC Analytical Development Solutions
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The document outlines CMC analytical development solutions in vaccine testing, highlighting that CMC deficiencies can delay marketing authorization by more than a year, reducing asset value by up to 20%. It emphasizes Covance Inc.’s expertise in analytical testing, with services including method development, routine lot release, and various quality attribute assessments for vaccines. Additionally, it promotes Covance's global capabilities in drug development, fostering smarter decisions and timely answers across the entire drug development continuum.
Vaccine CMC Analytical Development Solutions
- 1. Vaccine CMC Analytical Development Solutions EXCEPTIONAL SCIENCE, TIMELY ANSWERS AND ADDED VALUE DID YOU KNOW that one of the leading causes of delay in a drug or therapeutic candidate achieving marketing authorization is due to CMC deficiencies associated with analytical testing1 ? Consider that the average additional time to obtain marketing authorization with this type of delay can be up to a year or longer and the commensurate drop in asset value can be up to 20% or more2 . Trusted Insights to reduce the risk of CMC analytical testing deficiencies originate from scientific expertise & experience. 20+Years supporting the analytical development and testing of vaccines 23Commercial Biologic Products authorized for release/stability testing 19Vaccines supported in the last 3 years Helping You to make better choices of how you manage and what you spend to support your vaccine’s lifecycle. ▸ Analytical control strategy and plan to align with product CQAs ▸ Method development, phase appropriate qualifications & validation (GMP/ICH) ▸ Analytical testing (including in-process): safety, identity, strength, quality and purity ▸ Routine global lot release and stability testing under commercial GMP conditions 1. FDA Complete Response Letter Analysis: How 51 Companies Turned Failure into Success (FDA News Report) 2. Estimate based on rNPV model Vaccine Types ▸ Live-attenuated ▸ Inactivated ▸ Viral vector ▸ Virus-like particles ▸ Protein subunit ▸ Polysaccharide subunit ▸ DNA ▸ mRNA ▸ Polyvalent ▸ Synthetic ▸ Liposomes ▸ Loaded nanoparticles
- 2. Covance Inc., headquartered in Princeton, NJ, USA, is the drug development business of Laboratory Corporation of America Holdings (LabCorp). COVANCE is a registered trademark and the marketing name for Covance Inc. and its subsidiaries around the world. The Americas +1.888.COVANCE (+1.888.268.2623) +1.609.452.4440 Europe / Africa +00.800.2682.2682 +44.1423.500888 Asia Pacific +800.6568.3000 +65.6.5686588 © Copyright 2019 Covance Inc. SSCMC003-0119 BioCMC Analytical Testing Capabilities Exceptional science to help identify, assess and demonstrate control over your vaccine’s Critical Quality Attributes ▸ Trace analysis: residual HCP, Pro A, Insulin, residual DNA ▸ Sterility ▸ Endotoxin ▸ Sub-visible particles ▸ Residual antibiotics ▸ Excipient ▸ Residual methionine sulphoximine ▸ Mycoplasma detection ▸ Mycobacteria detection ▸ in vitro adventitious virus screens ▸ Circular Dichroism (Secondary and tertiary) ▸ Western Blot ▸ Identification by immunological, HPLC and PCR techniques ▸ Genetic stability ▸ Gene copy number ▸ Concentration ▸ Combination potency ▸ Dynamic Light Scattering ▸ Compendial testing ▸ BSL-2 ▸ BSL-3/ABSL-3 (Denver, PA) Smarter Decisions & Added Value from timely answers & novel solutions delivered via global capabilities across the drug development continuum and beyond ▸ Safety & Efficacy Pharmacology ▸ Toxicology ▸ Drug Metabolism ▸ Bioanalysis ▸ Clinical Development ▸ Regulatory ▸ Consulting & Partnering ▸ Informatics ▸ Commercialization ▸ Clinical Testing, including biomarkers & CDx GLOBALNetwork GLOBALProject Management 3 Nonclinical & clinical facilities offering development solutioins in support of submissions A single point of contact actively monitors and reports on your project from proposal to invoice GMP Analytical Development & Testing Labs across the UK & US