Return on investment of Raman instrumentation in upstream bioprocessing
In upstream bioprocessing, the product is the process. Having a consistently high-quality process means that the product’s Critical Quality Attributes […]
When someone has a headache, most often they reach for that bottle of aspirin that is always tucked away in their medicine cabinet. They don’t give it a second thought about how it got there, they are just thankful that it’s there when they need it. That is unless you’re Bethany Silva, Endress+Hauser’s Life Science Industry Manager. She shared her thoughts and insights into the industry in this Q&A.
I had been on the pharmaceutical distribution side of the industry working directly with hospitals and retail pharmacies. I wanted to understand more of the front side of pharmaceuticals with the development and manufacturing.
In Life Sciences we save and improve lives. Every day I get the opportunity to help our customers bring lifesaving and changing medicines to patients.
Continuous Manufacturing – Pharmaceutical manufacturers are starting to implement processes that are manufactured continuously compared to our traditional batch or fed-batch type of processes. The benefits are smaller footprints with more throughput and lower capital expenditure and production costs. The challenge is making everything automated and integrated in a continuous manner.
Flex Factories using plug-and-play single-use systems – Our customers are looking to have flexibility in their manufacturing footprints with being able to interchange multiple products seamlessly in and out of the production facilities. We see an adoption of open concept type of facilities called “ball rooms” with single-use equipment being able to be moved around and be interchanged as needed.
Pharma 4.0 and moving towards predictive maintenance – With all the increased productivity demands, there is less time for manufacturers to perform preventative maintenance, not to mention there is also an increased risk to manual intervention. The industry is moving towards more predictive automated maintenance schedules.
Smaller scales – Scales of processes are getting smaller as production efficiencies are getting better. With increased yields, pharma manufacturers are able to produce more with less.
Pharmaceuticals, in particular, biopharmaceuticals typically have a long road to market with the average being 10 years and investments being upwards of $2B before they have FDA approval and reach patients.
Since Covid highlighted some of the greatest challenges with vaccines and treatments, we have seen an enormous effort in getting drugs and medical devices to the market faster and cost-effectively. We have also seen the dependency on other countries for medical supply chain, and in response recently there have been several initiatives from regulators and the government for onshoring pharmaceutical manufacturing.
I believe we will have a great deal of Cell and Gene Therapy approvals as there are hundreds of Cell and Gene Therapy medicines in various clinical trial stages. We will see approval times improve, production scales become smaller and digitalization and continuous manufacturing become more implemented.
The most critical aspect for any Life Science customer is reducing risks to patients and patients’ safety. We at Endress+Hauser help our customers do so by being their “eyes and ears” and providing critical data on their manufacturing process to ensure a safe and effective medicine is available to the healthcare market.
In upstream bioprocessing, the product is the process. Having a consistently high-quality process means that the product’s Critical Quality Attributes […]
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