Delays in Biomanufacturing: What’s at the root of the problem?

Biomanufacturing is a difficult process, as anyone who works in the field understands, and there continues to be a great need for the work of biomanufacturing to become less expensive, more streamlined, and all around less problematic for biologics manufacturing companies. Understanding why biomanufacturing is so difficult and getting to the root of the problem can help change the process for the better and make it much more reliable for your company.

Why is Biomanufacturing Such a Difficult Process?

According to an article from MIT Technology Review, “Biologics––drugs made through a biological process rather than chemical synthesis, a category that includes recombinant proteins, vaccines, and antibodies––are the fastest-growing segment of the pharmaceutical industry.” The article goes on to discuss some of the most problematic issues of biomanufacturing, including:

The Cost

  • According to BioProcess International, “On average, a factory producing 120,000,000 L/year is estimated to cost $100,000,000” just to build. The costs of producing biologics is also high as the process itself is more difficult and the product more complex than other types of pharmaceuticals.
  • MIT states, “A single dose of some biologic therapies can cost $10,000.”

The Variability

  • Variability is an important obstacle for biologic manufacturers. Because the cells are alive, it can be extremely difficult and often impossible to produce the same results every time.

The Risk of Contamination

  • There is always a risk for medical manufacturers and contamination, but for biologics manufacturers, this risk is much higher.
  • This is why biomanufacturing calls for the regulation of not only the product itself but the manufacturing process as well. And because of the expense involved, this can limit innovations in the area.

According to Charles Cooney, an MIT chemical engineer, “Manufacturing sits on a critical path between science and the patient and should be integrated into the continuum of drug development.” But how can the problems and delays in biomanufacturing be solved? There are many theories being discussed in order to make the process and the products more reliable, and this is beneficial for both your company and the patient.

Higher Predictability

Higher predictability is one of the most important and most necessary changes that needs to be made in the process of biomanufacturing. According to The Cell Culture Dish, “Current biomanufacturing includes a process of selecting the best cell lines for cell viability, growth expression level, and product quality.” This helps companies like yours work toward higher predictability, but new technologies will allow better selection of the most reliable and “prolific” cells possible, in order to streamline the process more.

The high cost of biomanufacturing can be a difficult issue in the innovation of this manufacturing method, but putting attention and money toward the acquisition of better technology can be beneficial. Many companies now attempt to stay with the same technology until a new generation of products is in development, but this could be hurting the process of production overall.

Less Contamination

The use of animal components in cell culture media may be one of the biggest causes of contamination in the biomanufacturing process. According to The Cell Culture Dish, “Animal components are undesirable in manufacturing because they are undefined and yield unpredictable results due to high batch-to-batch variation” while also increasing the risk for contamination and safety concerns.

The consistency of cell culture media needs to be improved and the contamination factor will also be lowered by the use of animal-free media. This can help many of the issues that biologics manufacturers face when it comes to the process of creating their products. This kind of improvement can also make compliance with the regulation policies less costly.

Becoming involved in the testing and creating of new technologies, generating higher predictability in products, and finding ways to create products with less possibility for contamination will all be beneficial toward solving some of the issues that are delaying the process of biomanufacturing. While there are still difficulties to face in the process itself, innovation is key in biomanufacturing, a constantly expanding subset of the pharmaceutical industry that companies like yours are working to improve.