Changing Bioprocessing Paradigms Steering the Trend of Contract Biomanufacturing

Biomanufacturing is a novel biotechnological process of preclinical, clinical or commercial production of biological products like antibodies, vaccines or recombinant proteins using living, engineered or natural biological systems like microbes and cell culture systems. A biomanufacturing system should be incorporated with advanced, regulatory compliant bioprocessing technologies to suit the production of emerging, highly diversified biologic formats at higher titers or yield and with flexible and scalable biomanufacturing solutions to keep pace with the small scale product supply demands for preclinical and clinical studies and the rapidly augmented supply demands as the biologic product nears or approaches the market approval or commercialization stage.

The traditional biomanufacturing paradigms are now getting replaced with the more cost effective and quick to build novel, compatible and complementary options consisting of single use and continuous processing technologies, closed and functionally closed systems for the qualitative production of the highly diverse and complex biologics. Increasing demand for midscale biomanufacturing has also been observed currently due to the constantly evolving and changing trends of the biopharmaceutical industry associated with the fractioning of patient pool based on detailed analysis of disease cause and the development and approval of biologics for the orphan indications, for the highly specific personalized therapeutic approaches targeting the root cause of the disease and the emergence of cost-effective biosimilars. The emergence of advanced and novel therapeutic modalities like antibody drug conjugates (ADCs), cell and gene therapeutics require intense capital investments for building dedicated biconjugation, viral vector or cell therapeutics cGMP compliant manufacturing facilities, for their commercialization and also warrant regulatory and manufacturing expertise for scalability of their complex biomanufacturing processes.

The contract biomanufacturers, who provide biopharmaceutical manufacturing services on a fee for service basis, have been quick in the implementation of continuous biomanufacturing to improve scalability and quality of the products produced, in the execution of novel process analytical tools to enhance process robustness and commercial bioproduction with the efficient utilization of the available resources, in the adoption of single use or disposable systems for economical elevation of flexibility and also reduction of production lead times and in the execution of alternative and advanced downstream processing techniques to enhance production yields cost effectively. The agile CDMOs like Samsung Biologics equipped with large biomanufacturing capacity and technologically advanced capabilities offer clients efficient services at notably faster timelines, taking only 9 months for cell line development to drug substance biomanufacturing and 10.5 months for cell line development to drug product biomanufacturing. To differentiate themselves, attain a versatile service nature and thus gain more market share by effectively catering to the evolving needs of biopharma companies, the bioservice providers are constantly upgrading their capacities and technological capabilities. In September 2020, Catalent Inc. has invested $130 million for the addition of five additional suites to enhance their late phase clinical to commercial gene therapeutic manufacturing. In August 2020, Samsung Biologics had invested approximately $2 billion to build a fourth Super Plant with an additional 256KL production capacity to offer multi-scale manufacturing services while Lonza has expanded its microbial manufacturing facility in Switzerland to support the mid scale manufacturing demands from its clients. In April 2020, Lonza confirmed its plan of proceeding with the new seventh, mammalian biomanufacturing facility of the company that will be equipped with Cytiva’s KUBio cGMP modular, single use biomanufacturing platforms at 1,000L and 2,000L scales.

Partnership or collaborations with Contract development and manufacturing organizations (CDMOs) or Contract manufacturing organizations (CMOs) to get their requisite biopharmaceutical drug substance and drug product manufacturing services can be adopted as a strategy by the biopharma companies for economical commercialization of their innovative concepts. According to IQ4I analysis, the biologics contract manufacturing global market is expected to grow at a low teen CAGR to reach $57.1 billion by 2028. The global contract biomanufacturing market is driven by factors such as an increasing trend of the cheaper and highly efficient outsourcing practices among the biopharmaceutical companies, availability of advanced bioprocessing capabilities among the service providers, lack of in-house capacity and expertise, financial and time constraints for developing or building on specific or novel biomanufacturing capacities and capabilities as per the market needs, desire for multiple sourcing, escalating approval and adoption of biologic therapeutic products and emergence of advanced biotherapeutics. The outsourcing process enables large pharmaceutical companies to focus on their core competencies while for small companies and virtual start-ups, it is the only way to get their innovative biological products into the market without making huge investments on building the internal manufacturing capacities and capabilities. The shift of biopharmaceutical companies from high volume production to the low volume, more specific, targeted therapy or personalized medicine modality is also leading to an increased inclination towards biologic outsourcing to meet the demands of flexible and multiple product operations and requisite production scales. Thus the biopharma companies outsource their biomanufacturing processes to CMOs to accelerate the speed to market of their innovative products and to gain an economical and timely access to flexible and scalable, multi-product, most appropriate advanced biomanufacturing facilities and technologies along with skilled and technical expertise of the CMOs. For instance, in April 2020, Johnson and Johnson had partnered with the leading CDMO, Emergent Biosolutions for the manufacturing of its COVID-19 vaccine candidate. In September 2020, Exelixis, Inc. (U.S.) has partnered with Catalent for the development of multiple antibody-drug conjugates (ADCs) and CombiGene AB (Sweden) has signed agreement with Cognate Bioservices for the GMP production of plasmids for their gene therapeutics.

As this emerging therapeutics are testing the capabilities of the biopharma companies, CDMOs are stepping up their investments to secure a share in this high growth potential market of novel modality therapeutics outsourcing and to foster the small or virtual companies to accelerate the speed of their innovative products from bench to market. To enhance their capacities and to reduce competition in the market, some of the major CDMOs have adopted the strategy of acquisition. For instance, in July 2020, AGC Biologics, had acquired the Italian company, Molecular Medicine S.p.A. ("MolMed") which offers GMP services for the development and production of cell and gene therapies while in January 2020, Cognate BioServices had acquired Cobra Biologics, a leading CDMO specialized in plasmid DNA and viral vector development and manufacturing services.

According to IQ4I analysis, even though in-house biomanufacturing capacities still hold a major share of 67.8% in the biomanufacturing market, their capacity utilization rate (54.0%) is less compared to that of CMO’s with a utilization rate of 65.5%. Most of the CMO’s are currently utilizing mammalian culture techniques for the commercial, GMP production of biotherapeutics. Most of the CMO based biomanufacturing capacity is consolidated with major players like Samsung Biologics, Lonza, Boehringer Ingelheim, Fujifilm and AbbVie. The global medium penetration range of CMO biomanufacturing capacity is expected to increase immensely in the coming years attributed to the vast opportunity in the space and various capacity expansion projects being executed by the CMO’s in response to the elevating biomanufacturing capacity demand.

Thus the need to gain timely, cost effective access to the advanced, scale appropriate and multiple product biomanufacturing capabilities of CMO’s and the need to tap the novel biotherapeutic market of high growth potential as the advantageous first movers or to increase accessibility in the rapidly growing biologics market without making huge capital investments and by eclipsing the various risks associated with complex bio-molecule production is steering the increasing trend of biomanufacturing outsourcing.

Some of the major players in the contract biomanufacturing global market are Lonza Group Ltd. (Switzerland), Samsung Biologics Co. Ltd. (South Korea), Boehringer Ingelheim International GmbH (Germany), Thermo Fisher Scientific Inc. (U.S.), Catalent Inc. (U.S.), WuXi Biologics (Cayman) Inc. (China), JSR Corporation (Japan), AGC Inc. (Japan), Rentschler Biotechnologie GmbH (Germany), Genscript Biotech Corporation (China), Cognate Bioservices Inc. (U.S.), Charles River Laboratories International Inc. (U.S.), Merck KGaA (Germany) and others.



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