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  1. ILC Dover
30 May 2019

Helping Biopharma Create Life-Changeing and Life-Saving Drugs

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 mould to grow on the sample. The mould, 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 advanced biologics that treat autoimmune diseases such as rheumatoid arthritis and high-potency active pharmaceutical ingredients (HPAPI) to fight cancer. 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 litres have replaced Petri dishes, but, just as in Fleming’s day, producing these drugs includes a growing step.

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

ILC Dover is applying an innovation with high-tech materials to biopharmaceutical manufacturing and handling. The company is taking its 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, ILC Dover’s 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 Food and 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, ILC Dover designs its from a blank page, addressing every step in the process. This virtually eliminates cross-contamination risks, and by utilising its own antistatic material, the company ensures 99.96% 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 realises that ILC Dover’s technologies are helping the biopharmaceutical industry consistently and safely produce life-changing and life-saving drugs.

While design characteristics may be identical to rigid stainless-steel isolators, flexible film aseptic isolators offer several advantages for careful consideration.
A pharmaceutical production line must be safely and efficiently managed above all else. If a product becomes contaminated or production is delayed, it can have...
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