Title: Inspecting the Unexpected, Preparing quality control processes for COVID-19 vaccine candidates.

“These unprecedented times” have called for unprecedented measures. With the worst pandemic in a century continuing to take lives, cost jobs, disrupt education and complicate even mundane chores like grocery shopping, the devastating toll of COVID-19 has prompted the most ambitious race for a vaccine in modern history. Only rarely have successful vaccines been developed in under five years.1 The mumps vaccine, which was introduced in 1967, is typically seen as the gold standard—and even that took two years of human trials before its public release. Now, we’re talking about the possibility of a vaccine within a year of a novel virus’ global outbreak. If accomplished, it would be among the most amazing feats in the history of medicine. But a vaccine can only work its magic if it can be produced and made available to a critical mass of at-risk consumers which, in this case, means most of the world’s population of over seven billion people. Eradicating COVID-19, then, will require logistics advancements as well as medical ones. While the R&D effort so far has been impressive by any measurement, the manufacturing, quality control and logistics side of the broader pharmaceutical industry must begin zeroing in and catching up. Much like a production line is only as efficient as its slowest common denominator, an effort this vast and ambitious can only be as comprehensive and effective as the weakest link along the supply chain. For vaccine developers, that means finding the fastest route to a safe, effective vaccine; for their industry partners, it means having the processes in place to distribute it to consumers both around the corner and around the world. One step in particular could be a COVID vaccine choke point: Inspection, which has long exemplified the push-pull between speed and quality. In the case of vaccines, which typically are produced in glass vials and syringes, the inspection process means carefully scrutinizing filled containers for proper fill volume, contaminants, cosmetic defects, closure seal and leakage. Mission-critical challenges abound, including monitoring the formation of foam or bubbles, distinguishing between acceptable protein aggregates or protein flakes and unacceptable foreign particles and, on the container, determining whether a defect is an acceptable scratch or an unacceptable crack, typically one generated via thermal shock during cold storage. Rubber stoppers, plungers and other closure mechanisms also must be verifiable as leak-free.

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   Person Information
   Application Sequencing
Company  Product  Process  Other  Subjects  Event  Event  Date  Location  Publication  Publication  Date Text  Descriptor
  • Inspection

  • Quality Control

 

 

 

 

  • Contract Pharma

 

  • 11/17/2020

 

  • Article