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Industry Innovations for Biomanufacturing and Cell Line Development and Engineering

The 6th Annual Biopharma Development and Production Week was held from 3 to 5 November 2020, with three conference tracks discussing biomanufacturing, cell line development and engineering, and cell and gene therapy manufacturing, with a specific focus on China.

by Oh Sher Li

The three tracks were concurrent conferences themselves. The 10th Annual Biomanufacturing Conference which presented trends in biomanufacturing regulations, quality management, and biopharma supply chain integration. The 9th Annual Cell Line Development and Engineering Asia Conference which showcased new technologies, tools, and industry case studies for cell line development and engineering. Finally, the 2nd Annual Cell and Gene Therapy Manufacturing Conference, which discussed new innovations and technological developments in the production of cell therapies.

The biomanufacturing industry has grown rapidly due to their role in producing biologic-based drugs for the pharmaceutical and biopharmaceutical industries, which in turn have been experiencing increasing market demand. These products include antibody products and recombinant proteins, which can be used in research applications or for medical treatment.

Biomanufacturing is inexorably linked to cell line development and engineering since most biopharmaceutical products are produced in mammalian cell lines. Therefore, technology for cell line screening and for increasing the yield of cells during the manufacturing process are key priorities for biopharmaceutical companies.

A wide range of products have been developed by companies to optimise every detail at each step of biomanufacturing, from upstream processes to improvements in machinery. Several of these were presented at the 6th Annual Biopharma Development and Production Week, some of which are highlighted in this article.

Processes in Biomanufacturing

Before diving into the various technological developments for biomanufacturing, let us take a brief look at the processes involved, so that we can identify the areas to which the new developments are applicable.

Biomanufacturing typically involves first establishing a cell line that expresses a desired biological product. This can be done by engineering cells and selecting successful cells that exhibit the desired characteristics. Cell lines can be created from bacterial or mammalian cells, but for more complex protein products, mammalian cells are preferred due to their cellular machinery’s ability to carry out post-translational modifications, increasing the likelihood of obtaining functional products.

Successful cell lines are transferred to bioreactors, which are machines or systems that support the growth of cells. Bioreactors maintain controlled environments, and usually contain cell growth media, which is kept at specific temperature, pH and oxygen levels, to ensure that the cells in the bioreactor are growing in favourable conditions. While the cells grow, they continue expressing products, which are harvested and extracted.

Optimising Upstream Processes

Upstream processes in manufacturing industries are often overlooked, but as manufacturing technologies become more complex and the range of biomanufacturing products continues to expand, it is increasingly important to optimise all processes involved. One such process is powder-handling, which is important for the safe management of raw materials and prevention of cross-contamination.

Powder-handling is an key consideration in biomanufacturing because many buffers, media and salts are supplied and stored as powders. Besides storage concerns and minimising cross-contamination across samples, proper powder-handling methods also account for ease of transfer and could even help with efficiently mixing powders into liquid solutions.

The wide range of single-use powder handling products developed by ILC Dover is an example of how seemingly simple upstream processes could be optimised to improve downstream bioreactor-based activities. For instance, the company has three-dimensional (3D) two-port powder bags, whose larger openings and multiple ports reduce filling and discharge time. They also have trusted weight bags, which are used to transport specific weights of media or buffer to end user facilities. These bags facilitate research work by eliminating the need to measure out volumes and weights from bulk supplies. Furthermore, ILC Dover designed these trusted weight bags such that sampling from the bags can be done easily, either by collecting samples directly from bags, by using a tailgate sample attached to the trusted weight bag, or by in-invasive sampling with Raman spectroscopy without having to open the bag at all. The thought and consideration that goes into developing products for upstream processes like powder-handling can therefore bring great convenience, and even improve reproducibility for biomanufacturers.

Increasing Biomanufacturing Yield

Optimisation of bioreactor-based cell manufacturing is a crucial factor that directly impacts the quantity and quality of the final product. Among several challenges that the biomanufacturing industry faces, we will be taking a look at one in particular – the production of difficult-to-express proteins.

Difficult-to-express proteins, as their namesake suggests, are proteins that are typically challenging to synthesise using in vivo methods such as cell lines. They include some membrane proteins and antibodies, especially those whose structures need to be very precisely folded in order for them to be functional, such that any minor mutations or protein misfoldings would result in a significant negative impact on their effectiveness.

Glycotope, a clinical-stage immune-oncology company based in Berlin, presented their GlycoExpress (GEX) cell line as a potential way to tackle the production of difficult-to-express proteins. The GEX cell line acts as an alternative host specifically meant for the production of complex glycosylated proteins that are highly similar to human endogenous proteins, as compared with proteins from more common cell lines such as Chinese hamster ovary (CHO) cells. Besides difficult-to-express and complex glycosylated proteins, the GEX cell line is also able to express antibodies, enzymes, protein hormones, blood factors, and bispecific antibodies or fragments, such as immune cell recruiters.

Selexis SA, a Swiss company specialising in cell line development, also promoted their SUREtechnology platform, which features a proprietary high-performance mammalian cell line based on CHO cells, as well as a range of complementary products unique to the platform which enable biomanufacturers to optimise and control chromatic organisation, ensure stable integration of transgenes into the cells’ DNA, increase transfection efficiency, and select successfully transformed cells more easily.

The type of cell line used and the steps to obtain production cell lines that express functional proteins with high yield are critical to the success of the biomanufacturing process and of the company. With products that streamline these processes, the quality and yield of biopharmaceutical products are likely to continue to improve, in turn boosting their safety, accessibility, and affordability.

Ensuring High Quality Standards

With such rapid developments in the biomanufacturing and biopharmaceutical industries, regulations and best practices for these industries have also been updated. These changes include the introduction of Pharma 4.0 (an application of Industry 4.0 to the pharmaceutical industry) and the ICH Q10 pharmaceutical quality system, in addition to guidelines for technology transfer, biomanufacturing process validation, and quality risk management.

While all this may sound complex, in summary these regulations and guidelines are meant to ensure that pharmaceutical products, or in this case biopharmaceutical products, are produced in safe ways, from beginning to end. They are likely to continue to evolve as new biomanufacturing methods and technology are developed.

Conclusions

The technological advancements in biomanufacturing and cell line development and engineering are likely to contribute to the increased prominence of these areas in the pharmaceutical industry. With companies innovating across the multiple aspects of biomanufacturing, and coming up with products that give manufacturers the ability to generate a wide range of biopharmaceutical products in greater volumes, it is likely that the industry will continue to grow for many years ahead. Fortunately, with updated industry regulations and guidelines, industry practices continue to be monitored and managed, ensuring the safety and efficacy of products available on the market.

The 6th Annual Biopharma Development and Production Week gave us a look at some of the new developments in the biopharmaceutical industry, demonstrating just how much progress has been made in the past few years. While some of the highlights were presented during the conference, there are many other new technologies and considerations that go into establishing and optimising biomanufacturing processes. With such rapid growth in the industry and with so many companies working on improving these processes, we can look forward to seeing even more products and developments in the coming years.

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