How Far Has Biopharma Manufacturing Come in 2022?

Introduction

The state-of-the-art technologies of the biopharmaceutical industry have evolved dramatically over the last two decades. The industry has seen a remarkable increase in recombinant therapeutics primarily sourced from mammalian cell cultures.  The antibodies-based products have emerged which are expressed in microbial systems. There is an explosion of mammalian-expressed antibody products in the biopharmaceutical industry. These products were essentially unheard of or unthought of a few decades ago, but now they are an integral part of the industry and clinical medicine. On the manufacturing end, commercial-scale production of mammalian cell-based products and the use of single-use bioreactors are now on the horizon. The biopharma companies like Scorpion Biological Services have done well in evolving with the industry itself. 

Products and Technology

The mammalian cell culture products have increased the approved products by leaps and bounds. The size of the mammalian cell culture market was 1.90 billion dollars and it is expected to reach 5.31 billion dollars by 2030. The recombinant products include both mammalian and microbial products. Two decades ago the total amount of these products was almost equally divided between the two i-e almost half products were mammalian and half were microbial. But, in 2022, the total number of available recombinant products has increased with mammalian products constituting 68% of the total. 

Driving Factors Behind the Increased Mammalian Products 

Analysis shows that the increase in mammalian antibody-sourced products is the major driving force behind this steep increase. The non-antibody sourced mammalian products have shown a growth of 4.7% per year in the last two decades as opposed to the 13.9% yearly growth rate of antibody-based mammalian products. The antibody products include:

• Monoclonal antibodies
• Antibodies fusion proteins
• Antibody fragments
• Assortment of radiolabels, drugs, and polyethylene glycol moieties leveraged by antibody fragments conjugation

The non-antibody products include:

• Blood proteins
• Cytokines
• Hormones
• Enzymes
• Peptides
• Other proteins

The overall distribution has shifted from a majority of non-antibody products (83%) to a balance between antibody (47%) and non-antibody (53%) products due to the yearly increased growth rate of antibody-based products. 

Why?

Two decades ago microbial expression systems were majorly used for non-antibody products. But now, almost 8% of approved microbial expression systems are represented by antibody-based products. 

Biomanufacturing Technologies

Over the last two decades, the implementation of single-use technology has increased significantly. The capacity of single-used bioreactors, for mammalian cell products, has increased from 15 percent to 13 percent volumetrically in the last few decades. While the use of single-use bioreactors has increased by 30 to 40% altogether. The single-use fermenters did not exist a couple of decades ago but today they represent 1-2 percent of microbial-based manufacturing capacity.  Single-use technology also spans the industry from bioreactors to chromatography columns and filling systems. 

Initially, the antibody-based products were generated by in-vivo methods. In 1975, Kohler and Milstein invented Hybridoma Technology which prepared the stage for advanced manufacturing of antibody-based products. Today, antibody-based technology has evolved to constitute a standardized development and discovery protocol. Some recent technology innovations for developing antibody-based products are as follows:

• Sequence optimization
• Improved antibody target affinity
• Epitope prediction
• The ability of antibodies to target proteins that are difficult to separate
• Artificial technology and advanced computing
• Equipment advances
• Automation

For many bioprocessors, combining a highly intense cell perfusion system with continuous processing is becoming an achievable goal. These advancements will help in decreasing the physical footprint of bioprocessing and increasing the productivity and efficiency of the whole operation via advanced technology and smart biomanufacturing.

What the Future Holds

With the evolution of technology and manufacturing processes, it is no wonder that antibody-based mammalian cell products have reached this far up in the market. In 2022 and beyond that, the biopharmaceutical industry’s efforts are bending onward continuing advancements in technologies and manufacturing along with cutting costs. It will result in affordable products for the general public. It will also allow the companies to penetrate the cost-sensitive market and to reach the area of the market which was once barred due to the expensive products i-e the people who can not afford expensive treatments. It will in turn increase the revenue. Cutting the manufacturing costs is no small feat and it will require tremendous efforts on the part of the industry. So, cost-effectiveness will be seen as the area of focus for the next few years!