ILC Dover applies insight and experience to reduce contamination in biopharma production
The circumstances that gave birth to the biopharmaceutical industry are the same circumstances that present one of its key challenges – contamination. Most of us recall the story from our school days: In 1928, scientist and physician Dr. Alexander Fleming accidentally left a petri dish of bacteria culture uncovered, allowing mold to grow on the sample. The mold, Fleming observed, was preventing the bacteria from multiplying. Fleming had discovered penicillin.
Biopharmaceuticals have come a long way
Modern medicine soon had its first lifesaving, miracle biopharmaceutical drug: antibiotics. It was also the beginning of the biopharma industry – microscopic drugs that were cultured instead of chemicals that were mixed. Today’s biopharmaceuticals include not only an array of antibiotics, but also advanced biologics that treat autoimmune diseases such as rheumatoid arthritis and High Potency Active Pharmaceutical Ingredients (HPAPIs) to fight cancers. Progress in genetic technology promises future breakthrough discoveries as revolutionary as Penicillium notatum.
Cross-contamination remains a challenge
Making these drugs available to healthcare providers and their patients requires sterile manufacturing processes. Reactor vessels capable of holding hundreds or thousands of liters have replaced petri dishes, but, just as in Fleming’s day, producing these drugs includes a growing step. And, just as in Fleming’s day, there is the risk of contamination. The ideal conditions for culturing biopharmaceutical products are equally inviting to molds, bacteria and other contaminants that can ruin the entire “batch.” Instead of fortunate happenstance, the results are increased costs and lost production.
ILC Dover innovates for biopharmaceutical manufacturing
At ILC Dover, we’re applying our innovation with high-tech materials to biopharmaceutical manufacturing and handling. We’re taking our insights into protecting people and assets to develop products that reduce the risk of contamination and improve the efficiency of biopharmaceutical manufacturing.
Take, for example, our single-use system for transferring powders. The powders we’re talking about are typically inert: media, buffers or “food” sources such as glucose to support the growth of biologics. However, the transfer process needs to keep unwanted “bugs” out of the recipe. Likewise, since the powders support microbiological activity, any spills encourage those uninvited critters to do what comes naturally – make more of themselves at an exponential rate. With ever-finer detection technology and tighter Federal Drug Administration (FDA) standards, it doesn’t take much to reach unacceptable contamination levels.
Technology designed specifically for powders
Unlike other powder transfer systems which were adapted from liquid use, we designed ours from blank page, addressing every step in the process. This virtually eliminates cross-contamination risks, and by utilizing our own antistatic material, we ensure 99.96 percent complete transfer. The single-use products also reduce clean-up, making them an economical option for biopharmaceutical manufacturing.
Helping deliver life-changing and life-saving drugs
All of this may seem a bit esoteric to the layperson, until one realizes that ILC Dover’s technologies are helping the biopharmaceutical industry consistently and safely produce life-changing – and life-saving – drugs.