The growth of single-use technologies can be attributed to the growing need for better, cheaper, and faster biologics production. Active development of individualized biologics and personalized medicines, including patient-specific cellular gene therapies and therapeutic vaccines, demands high sterility and is therefore manufactured using single-use equipment and consumables.
In recent years, more biologics having higher potency that require smaller production volumes, advancements in biosimilars targeting smaller markets, and ongoing improvements in production yields and efficiencies that create production operations at much smaller scales have increased the use of single-use technologies such as single-use bioprocess containers/bags as they are best suited for small volume productions. However, single-use technologies are now slowly moving towards clinical production and commercial operations.
In 2020, the US FDA approved 53 new medicines and therapeutic biologics (Source: US FDA). Growth in the biologics market is mainly driven by monoclonal antibodies and human insulin, which are among the leading contributors to the bioprocess containers market. Additionally, the Centre for Biologics Evaluation and Research’s (CBER) (2021-25) strategic plan involves various schemes for boosting the growth of the biologics market.
Compared to traditional bio-manufacturing technologies, single-use systems (SUS) have many advantages, such as reduced requirements for process validation and higher manufacturing flexibility, which ultimately results in higher operating efficiency and reduced manufacturing costs.
Despite these advantages, there is a possibility that the plastic materials used for SUS may leach organic compounds or inorganic substances into the processing fluid or the final drug product, which remains a major concern. Such an undesired change could eventually compromise bioprocessing and might significantly impact the safety, quality, and purity of the drug product.
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According to a survey conducted by BioPlan Associates in 2018, 73.3% of respondents agreed that leachables and extractables are major concerns that may limit the use of bioprocessing in the near future. As single-use assembly products are made of processed plastic materials, they often face the problem of contamination from the container due to leachables.
The patent expiry of blockbuster drugs has resulted in increased RD spending by pharmaceutical and biotechnology companies. Patent expiry of biologics leads to increasing RD of biologics and shifts biologics from the pipeline to commercial production. As the development and manufacturing costs of biologics are very high, companies are now gradually focusing on techniques that are more economical than traditional biomanufacturing methods.
Most single-use assemblies are made of multiple materials or layers, including polyethylene, polypropylene, ethylene vinyl alcohol, or nylon. Such products require extensive efforts to separate components into homogeneous components. As a result, most single-use assemblies and their components are not suited for recycling. This leads to the generation of large volumes of solid waste; its disposal is a challenging prospect for biopharmaceutical companies.
In June 2021, Avantor, Inc. (US) acquired RIM Bio, a leading China-based manufacturer of single-use bioprocess bags and assemblies for biopharmaceutical manufacturing applications. This acquisition helped the company expand its bioproduction footprint in China.
In April 2021, Sartorius Stedim Biotech (France) opened a new Customer Interaction Center (CIC) in Beijing, China, to expand its presence in China and to meet the high demand from the growing biopharmaceuticals market.
In March 2021, Merck KGaA (Germany) invested ~USD 30 million (EUR 25 million) to add a single-use assembly production unit at its Life Science Center in Molsheim, France. With this expansion, the company is accelerating its European expansion plans for single-use technology, which is used for the production of COVID-19 vaccines and other lifesaving therapies.
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