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Biopharmaceutical will usher in the era of "bio manufacturing 4.0"

2020-05-06 08:18:33

Recently, Dr. Atul mohindra, senior director of research and development, Lonza, the world's leading supplier in medicine, health care and Life Sciences, discussed various issues related to bioprocessing 4.0 and how new technologies affect the biological and pharmaceutical industries.

First of all, we will not call the term 'bioprocessing 4.0' the standard term, because there are various new and content in the model. We cannot forget that although the word "bioprocessing 4.0" and its concept are new to our pharmaceutical and biological industries, it has been used effectively in other industries for several years. The oil and automation industries are the most obvious examples of this.

As early as 2017, FDA has released the guidance on innovative technologies for biopharmaceuticals, seeking to incorporate "promising emerging technologies" into its drug production process. The guide is entitled "advanced of emerging technology applications for pharmaceutical innovation and modernization" and provides advice to companies interested in participating in the FDA's emerging technology program.

In a statement, Scott Gottlieb of the FDA Committee said: "we not only encourage active innovation in new therapies, but also strive to promote technological innovation in the advanced technologies used to manufacture these products, because both aspects are at an important turning point in future practice. FDA is committed to continuing to drive progress in innovative drug manufacturing, with the potential to ultimately improve drug quality and safety. "

When FDA issued this guideline, it also provided some examples of emerging technologies that may be considered, which are divided into three categories:




Class 1: emerging small molecule technology

Continuous production of API

Continuous production of drugs

Model based continuous manufacturing control strategy

Continuous aseptic spray drying

3D printing manufacturing

Super long acting oral preparation

The second category: emerging biomolecular Technology

Controlled nucleation process in freeze-drying process

Advanced process control, such as predictive model of process monitoring and closed loop bioreactor control

Multi attribute method

Next generation sequencing

Continuous manufacturing of downstream processes

On demand pharmaceutical manufacturing (small manufacturing platform for continuous biological processes)

Category III: emerging technologies for multiple products

Closed aseptic filling system

Isolator and mechanical arm for aseptic filling

New containers and closure systems for injection products

Now, the pharmaceutical and biological industries are driving the industry's commitment to automation and digitalization, and we are taking advantage of many opportunities that were not previously possible. At Lonza, technical challenges that can now be addressed include reducing process deviation through predictive monitoring, reducing batch release time through real-time release testing technology, and finally predicting or reducing facility maintenance through the use of automated tools on the device.

Mohindra cited a specific case in which the biological treatment 4.0 model improved the company's technology. "We recently implemented process analysis technology (PAT) at the factory," he explained By using this technology in the development stage of the program, we can even use more intelligent modeling tools to design and model the process. In addition, once these technologies are implemented, we will be able to generate a large amount of data that can be used for other purposes. But there are many other applications, such as using robots and data analytics to monitor the environment in our facilities. "

There are other benefits to new insights into the company's infrastructure. "By introducing machine learning algorithms, Lonza was able to introduce state-of-the-art tools to image and select cells in our cell line development plan," he continued. Therefore, we see bioprocessing 4.0 as a breakthrough approach, especially when you consider applying it to machine learning at the network level or batch publishing of real-time data. "

There has always been a disconnect between upstream and downstream biological treatment, because the progress of upstream cell culture technology is faster than downstream treatment, separation and purification.

Mohindra stressed: "we believe that progress in the concept of bioprocessing 4.0 should help ease the disconnect that the industry has to address. As we pay more attention to the implementation of automation and digital tools, we will inevitably check all operation units in a modular way to extract the maximum value of the generated data. In order to achieve this goal, we need to make significant progress in purification and purification, and quickly! "

With regard to the urgent and urgent production challenges posed by the threat of coronavirus covid-19 and the rapidly increasing demand for production, mohindra believes that the bioprocessing industry has sufficient resources to meet the production challenges to be realized in the coming months. "I believe the industry is ready to deal with the threat of covid-19," he said

Looking to the future, mohindra predicts that "many companies have made significant progress in finding solutions and I believe that if the industry consolidates its efforts (in development and manufacturing), we will have a faster and sustainable global supply chain continuation."


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