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Understanding the Fill Finish Process

The value of the fill-finish manufacturing market is estimated to reach $5.15 billion by 2024, according to a report published by Zion Market Research.1 Pharmaceutical and biotechnological companies dominated the fill-finish market in 2017.1

Drug products that are delivered to individuals via the parenteral, ophthalmic, or inhaled routes typically bypass the body’s immune system. The US Food and Drug Administration (FDA) requires that Pharma companies package these types of drug products using a sterile method for the safety of consumers. However, the fill-finish step has proven to be a major rate-limiting step in the process of delivering vaccines, according to a report to the president on reengineering the influenza vaccine.2

The fill-finish process is a significant step in the drug manufacturing process. When manufacturing injectable vaccines, there is no method for sterilizing the vaccine when it has been packaged in its final container. This is why the vaccine needs to be filled in an sterile environment, also known as an aseptic fill-finish. During this step, the sterile drug is transferred from a filling needle to a sterile container such as a vial or syringe. Any marginal error in this process can lead to quality failure and can cause harm to recipients of the vaccine. Aseptic processing is challenging due to the need for specialized equipment and skilled personnel. The FDA only recommends this step for formulations where terminal sterilization is not possible.

As the COVID-19 pandemic stretches over the second wave, over 50 million cases and 1.25 million deaths worldwide have been recorded. The global hunt for a vaccine is more important now than ever before, and scientists are researching at a breakneck pace. Through Operation Warp Speed (OWS), the federal government has accelerated the efforts of researchers and organizations to develop and distribute vaccines that are effective and safe.1

The Food and Drug Administration (FDA) has provided guidance for fast-tracking vaccine development and market approval of a COVID-19 vaccine. So far, OWS has funded Phase III trials for three vaccines: Moderna’s mRNA-1273, University of Oxford and AstraZeneca’s AZD1222, and Pfizer and BioNTech's BNT162.2 OWS is also partnering with more than 18 biopharmaceutical companies as they race to develop more vaccine candidates.2

The Relevance of Primary Packaging in Maintaining Drug Stability

From the moment pharma companies formulate a drug to when a doctor injects it into a patient, the primary packaging (the packaging that is in direct contact with the drug) plays a crucial role in preserving and protecting that drug.

Drug stability is a drug’s capacity to maintain the chemical, physical, microbiological, therapeutic, and toxicological properties it possessed at the time of its manufacture throughout storage and usage.1 Pharmaceutical companies typically perform stability testing throughout the entire drug development process. The primary packaging of a drug can significantly affect its stability over the shelf life of the drug. As the government’s Operation Warp Speed (OWS) races to get COVID-19 vaccines to the 328.2 million people of the United States, pharma companies are scrambling to ensure that they have sufficient primary packaging options that are effective and safe. The OWS goal is to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021.

The Significance of Container Closure Integrity (CCI)

Establishing a well-defined container closure system preserves the sterility of a drug over its shelf life. Container closure integrity (CCI) is important because it determines product and consumer safety. To keep patients safe, pharma manufacturers should implement container closure systems that avert contamination from microorganisms, reactive gases, and other substances.

Although scientific evidence shows that the benefits of vaccines far outweigh the risks, historically, there have been several major concerns about the safety of vaccines. One notable case of a vaccine recalled by Merck & Company, Inc. highlights the potential risk of contamination. In 2007, Merck recalled 1.2 million doses of Haemophilus influenzae type b (Hib) due to concerns about potential contamination with B. cereus, a type of bacteria that causes food poisoning or gastrointestinal infections. Fortunately, there were no reports of infection from B. cereus in the individuals that received the vaccine.1

What happens to monopolized industries? They grow stale. The needs of customers go unmet as incumbents feel content to provide only small iterations, confident in their knowledge that they own the market outright.

Innovation thrives on competition. Businesses need to feel the pressure of disruption at their backs to pursue new ideas and meet the evolving needs of their customers. Industries with little competition invariably innovate less than industries where competition is rampant.

The tech boom of the last 20 years delivered a wake-up call to many industries that had previously considered themselves safe. By now, most markets have shifted to favor the innovators, but a few have fallen through the cracks. For one such industry, pharmaceuticals packaging, that's about to change.

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