Date: May 5 @ 11 am ET
A Conversation with Christopher Andrews, Solution Consultant, BIOVIA Life Sciences
In general, drug companies want to make their products on time. What is so special about vaccines?
Vaccines are a special case with additional urgencies. The obvious current scenario is that we are in the midst of a deadly pandemic. We might be getting closer to the end of it. However, plenty of places around the world still need vaccine rollouts. If we are going to end this worldwide pandemic, it is critical that we get these vaccines approved and out the door. Additionally, various companies that are manufacturing vaccines and therapeutics have made very high profile commitments to local and federal governments. Today there is an absolute urgency to get this done.
What are some of the challenges that are causing vaccine delivery delays?
BioPharma companies have developed these vaccines in record time, and, whenever you introduce a new drug, there is a regulatory approval process. We need to accelerate every part of this process. Every regulatory submission includes qualification of the manufacturing facility. You need to complete these qualification runs on time before you can start producing the vaccine and getting it out the door. First, you need to have a quality control system in place to validate your manufacturing processes. Additionally, because these vaccines are new technology, requiring new manufacturing capacity and processes, there is a great deal of outsourcing going on. Even though the sponsor company has come up with the process for developing the vaccine, they might not have the necessary equipment or production lines, so they outsource vaccine production to contract manufacturing organizations. This adds another level of complexity to developing the vaccine, qualifying facilities, producing vaccines and bringing them to market.
There can be obstacles in bringing vaccines to market. How can we avoid these holdups?
There are likely multiple reasons for holdups. You might have multiple products going through your production lines. You need a system to control and double-check what goes into a particular recipe. To achieve this, you need a second verifier to look at the process and make sure that it is producing a quality product. Bottom line, you need technology to buttress against potential human error, and this is where laboratory and manufacturing informatics comes into play. There is always going to be a human element, so you need a system of checks and balances to alleviate this risk. For example, you need a system that will protect you from cross-contamination of ingredients or products on a line. If you have paper batch records, your teams are writing information down on paper and then only reviewing it after the fact. If you move that review further up the line, capture that data electronically and have a second person entering the same data, you then have two sets of eyes. Then, if you also have technology that automatically compares these two values, you should be able to avoid costly mistakes and potential production delays. Bar code scanners and electronic systems deliver a higher level of data integrity. They can make a big difference.
Can you expand on the role played by data in delivering vaccines on time?
Drug manufacturing generates a massive amount of data. What we see today with many BioPharma manufacturers around the world, especially those working with contract manufacturers, is a great deal of “siloed” data. This is especially challenging with biologics, where the processes are longer and the materials are more expensive. Materials can be very sensitive to perturbation, in terms of temperature, pH, etc. Consequently, you have all these data systems generating large amounts of data for very complex manufacturing processes. You need to bring all of this together, so you can understand if your processes are in a state of control with known sources of variability. This effort can be an extraordinary time sink. Generally the rule of thumb is—if you want to consider the 80-20 rule—you end up spending 80% of your time looking for data and bringing it all together. You spend only 20% of your time gaining valuable insights and acting on them.
What role does CPV and process intelligence play in delivering vaccines on time?
A comprehensive Continued Process Verification (CPV) and process intelligence solution like BIOVIA Discoverant flips the 80-20 rule on its head. BIOVIA Discoverant drastically reduces or even eliminates the non-value added work of hunting for data and bringing it together in a single place in a format that process scientists and engineers understand. They do not need to know where the data resides. The data they need is at their fingertips, automatically aggregated and contextualized in a high data integrity environment. Most importantly, the data is validatable and 21 CFR Part 11 compliant. This means your process scientists and engineers do not have to copy and paste data into Excel spreadsheets using non-validated, external solutions. They have the data they need, in the format they want, so they can understand their sources of process variability before quality issues arise. Instead, they can focus on process improvement.
Ultimately, in terms of making vaccines on time, whenever you eliminate non-value-added busy work, you are shortening the vaccine (or other drug) development lifecycle, so you can get vaccines out the door and into patients’ arms sooner.
Webinar: Manufacturing New Vaccines and Biologics on Time
Speakers: Christopher Andrews and Stéphane Vellay
Date: May 5 | 11AM ET