Bioprocess Containers (BPCs) are ready-to-use single-use flexible container systems for important liquid handling applications in biopharmaceutical and biomanufacturing operations.

Advantages of Ready-To-Use Single-Use Bioprocess Container Systems Fuels Its Demand

Over the years, there has been an increase in the adoption of single-use bioprocess containers (BPCs) because of their demonstrated performance, and cost- and time-saving benefits. Single-use technology (SUT) products are widely accepted for the manufacturing of vaccines and biologics. Some of the key benefits that are driving its demand are:

• Operational Benefits & Reduced Risk of Cross-Contamination: Bioprocess container systems reduce the risk of cross-contamination. Moreover, the elimination of cleaning-in-place and sterilization-in-place (CIP/SIP) systems reduce setup, maintenance, and validation times, thereby enabling increased output
• Ready Integration: Bioprocess container components work well in all stages in the production of therapeutic biologics and vaccines
• Reduction in Cost of Goods Sold (COGS): Bioprocess container systems reduce capital investment and labor costs, which in turn leads to a reduction in COGS
• Scalability: Bioprocess container systems are well suited for use from benchtop to production scale processes

High Development & Manufacturing Costs of Biologics Coupled With Its Patent Expiry Likely to Drive the Demand of Single-Use Bioprocessing Technologies

Biologics currently hold nearly half of the pharmacological market for oncology. By 2023, patents on nearly 20 oncology biologics are expected to expire. Patent expiry of biologics is expected to result in subsequent launch of biosimilar drugs. Application of single-use systems in biosimilar development is expected to bolster the demand of bioprocess containers.

The development of biologics including cell & gene therapies and therapeutic vaccines demand high sterility and therefore biologics are increasingly being manufactured using single-use equipment and consumables.

As the development and manufacturing costs of biologics are very high, companies operating in the market are increasingly focusing on techniques that are more cost-effective than traditional bio-manufacturing methods. In an endeavor to manufacture cost-effective products, several biopharmaceutical manufacturers are incorporating single-use bioprocessing technologies into their development processes.

 “Biopharmaceutical manufacturers use a range of bioprocess containers (BPCs) during the production and storage of biopharmaceuticals. The trend of “single-use” or “disposable” BPC technologies in the biopharmaceutical industry enables greater flexibility and better use of production facilities that are increasingly designed for multiple products.”- Senior Director, Leading Bioprocess Container (BPC) Manufacturer, United States

Risk of Leachables from Single-use Bioprocess Containers – A Deterrent for Bioprocess Containers Market Growth

Single-use assembly products are made of processed plastic materials and they frequently face the risk of contamination from the container due to leachables.

Leachables are chemical compounds that migrate into the drug formulation from any product contact material (such as elastomeric, plastic, glass, stainless steel, or coating components) as a result of direct contact with the drug formulation under normal process conditions or accelerated storage conditions and are found in the final drug product.

Leachables from single-use bioprocess containers (BPCs) are a source of process-related impurities that have the potential to alter the product quality of biotherapeutics and affect patient health. However, despite these challenges, single-use technologies uptake is expected to grow as suppliers & end-users are working together on this issue. Proper risk assessments, characterization of extractable profiles according to more standardized protocols, toxicological assessments, leachable studies, and matured guidance guidelines are some of the mitigation steps undertaken by stakeholders to confront the problem of leachables.

Competitive Landscape Analysis: Bioprocess Containers Market

The Bioprocess Containers market is marked by the presence of key players such as Sartorius Stedim Biotech (France), Thermo Fisher Scientific (US), Danaher Corporation (US), Merck Millipore (Germany), and others.