Navigating the Business Strategies of Industry Players Acing the $10.65 Billion Cell and Gene Therapy Manufacturing QC Market
Cell and gene therapies have attracted significant investments and garnered strong support from both the scientific community and regulatory bodies. The success of these therapies hinges on stringent quality control measures throughout the manufacturing process, ensuring safety, efficacy, and regulatory compliance.
This has led to an increasing demand for quality control (QC) during the manufacturing process, which has subsequently opened new avenues for industry players and startups to tap into the market.
According to the BIS Research report, the global cell and gene therapy manufacturing QC market was valued at $1.95 billion in 2022 and is anticipated to reach $10.65 billion by 2033, witnessing a CAGR of 16.85% during the forecast period 2023-2033.?
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This article revolves around how the industry players are strategizing and implementing business approaches to position themselves as leaders in the highly competitive landscape.
1. Cytiva Launched Versatile Bioreactors to Simplify Bioprocessing Operations
In April 2023, Cytiva, a leading global biotechnology company acquired by Danaher, introduced X-platform bioreactors to simplify single-use upstream bioprocessing operations. These bioreactors, available in 50 and 200 L sizes, are equipped with a Figurate automation software solution, enabling enhanced process efficiency, streamlined supply chain operations, and ergonomic improvements.
These versatile bioreactors can be used for producing monoclonal antibodies, protein-based drugs, cell and gene therapies, and viral vectors. They offer flexibility and efficiency in bioprocessing, facilitating the development and manufacturing of various therapeutic products.
Moreover, the X-platform bioreactors are compatible with the Cytiva Bioreactor Scaler, eliminating the need for trial and error by determining optimal scaling settings.
2. Charles River Laboratories Unveiled Off-the-Shelf pHelper Plasmid
On March 9, 2023, Charles River Laboratories International introduced an off-the-shelf pHelper plasmid, aiming to streamline the manufacturing process of adeno-associated virus (AAV) vectors for gene therapy programs.
The pHelper plasmid has been availed in different grades to support research, high-quality, and Good Manufacturing Practice (GMP) requirements. By providing a reliable and readily accessible supply, Charles River would simplify the complex supply chains associated with AAV-based gene therapy.
The plasmid is manufactured and released with comprehensive chemistry, manufacturing, and controls (CMC) information and a certificate of analysis (COA) to support regulatory filings.
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3.?Thermo Fisher and Arsenal Biosciences Partnered to Support Clinical Manufacturing of Autologous T-Cell Therapies
On March 29, 2023, Thermo Fisher Scientific and Arsenal Biosciences joined forces to support the clinical manufacturing of autologous T-cell therapies for cancer treatment. Through their strategic collaboration, Arsenal Biosciences successfully developed a robust manufacturing process for their programmable autologous T-cells.
This collaboration enabled Arsenal Biosciences to advance their lead product candidate, an autologous integrated circuit T-cell (ICT) therapy for platinum-resistant ovarian cancer, into clinical manufacturing.
The collaboration aims to bring more innovative treatment options to patients in need and improve the economics of therapy production. Thermo Fisher's Current Good Manufacturing Practice (cGMP)-manufactured cell therapy systems (CTS) products meet cell therapy standards and support the transition from research to clinical production.
4.?Purespring Therapeutics and Charles River Laboratories Announced Plasmid CDMO Alliance
On February 15, 2023, Charles River Laboratories and Purespring Therapeutics announced a collaboration in plasmid DNA contract development and manufacturing organization (CDMO) to support the development of a gene therapy platform for kidney diseases.
Leveraging Charles River's eXpDNA plasmid platform and expertise in manufacturing, the program focuses on Purespring's innovative adeno-associated virus (AAV)-based gene therapy that targets the podocyte, a specialized kidney cell type.
5.?Bio-Techne Introduced MauriceFlex System for Streamlined Protein Characterization
On January 26, 2023, Bio-Techne Corporation launched the MauriceFlex, a ProteinSimple-branded system to enhance protein characterization workflows. It combines protein charge variant fractionation with routine capillary isoelectric focusing (cIEF) and capillary electrophoresis?sodium dodecyl sulfate (CE-SDS) assays, offering a versatile solution for comprehensive protein analysis.
The system enables efficient separation and collection of protein variants for further analysis, eliminating the need for additional methods such as ion exchange chromatography. Moreover, it also facilitates direct analysis of collected fractions without the need for mass spectrometry sample preparation.
The Road Ahead
The global cell and gene therapy manufacturing QC market sees great potential in the future up to the valuation of $10.65 billion, which resembles a fruitful opportunity for industry leaders and entrants to reap the benefits.
Moreover, automation and advanced analytical technologies will play a crucial role in ensuring the safety, efficacy, and consistency of cell and gene therapies. Integration of artificial intelligence and machine learning will further enhance QC processes, enabling real-time monitoring and predictive analytics.
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