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Volume 31, Issue 4
Developments and investments in single-use systems advance upstream biomanufacturing.
Although adoption of single-use manufacturing technology throughout the industry remains low, the market for these systems is expanding as biopharmaceutical capacity needs change (1). Despite this trend, single-use systems can provide substantial production advantages for various bioprocesses, particularly those involving upstream applications. The following are some of the latest developments in single-use products and equipment available for upstream processes.
Watson-Marlow Fluid Technology Group (WMFTG) has added Q Clamp, a new sanitary tri-clamp connection for single-use fluid path applications, to its BioPure brand (2). The clamp can provide a secure connection in less than 12 seconds, according to the company.
The clamp does not require any tools for application or removal and can be closed using one hand. The company reports that a double-sided ratchet ensures that the lightweight clamp remains shut in the event that one side should fail.
The clamp comes with a tamper-evident identification technology solution for tri-clamp connections, which can also be used for identification through eight different color options, allowing procedures to specify relevant areas of the process, according to WMFTG. Application of this solution is possible either before or after the clamp is assembled.
The connection tri-clamp, which is backed by a validation pack for non-wetted components, is manufactured and packed in an International Organization for Standardization (ISO), Class-7 cleanroom and meets current ISO and United States Pharmacopeia <87> and <88> industry requirements. The company also confirms that the clamp has been evaluated for extractables using a single solvent approach.
Sartorius Stedim Biotech’s new automated parallel bioreactor system, ambr250, is a high-throughput bioreactor system suited for rapid cell-culture perfusion culture process development to increase therapeutic antibodies production (3).
The system combines 12 or 24 single-use perfusion mini bioreactors with associated single-use perfusion components, all controlled by one automated workstation, as stated by the company. The mini bioreactors have a working volume range of 100-250 mL.
According to Sartorius Stedim, the combination of this multi-parallel processing capacity and fully single-use perfusion vessel allows for more perfusion culture experiments in less time and cost compared to traditional perfusion-enabled benchtop bioreactors. The system is suitable for a range of hollow fiber perfusion applications, which allows for design of experiments studies for high cell density process development in a quality-by-design approach.
The system, which is a collaborative effort between Sartorius Stedim and other biopharma companies, uses a perfusion bioreactor assembly based on the company’s branded bioreactor design. Components such as high efficiency spargers, perfusion pump chambers, and an industry-standard hollow fibre for cell retention filter enable intensified cell culture processing.
The system’s fully assembled and irradiated perfusion bioreactors come with all necessary components, including single-use sensors to continuously monitor pressure at both the culture fluid inlet and permeate outlet, which enables online monitoring of transmembrane pressure and standard parameters such as pH and dissolved oxygen.
In response to available and emerging single-use technology, biopharmaceutical contract service providers have invested in single-use products, equipment, and companies.
In January, Sartorius Stedim Biotech announced that it will be the equipment supplier in the United States for Abzena, a life-sciences group that provides services and technologies for the development and manufacture
of biopharmaceuticals (4).
Abzena has selected Sartorius Stedim to equip its integrated contract development and manufacturing facilities in Bristol, PA, and San Diego, CA. The Bristol facility does development and GMP manufacture of antibody drug conjugates, and the San Diego facility does development and GMP manufacture of monoclonal antibodies and other recombinant proteins. Under the agreement, Sartorius Stedim will provide both facilities with end-to-end process solutions in single-use format.
The company will equip Abzena’s San Diego process development lab with industry technologies, including the previously mentioned ambr250, which will enable scale-up to 500 L initially and 2000 L later for Abzena’s center of excellence in clinical manufacturing.
Also in January, Meissner Filtration Products, a developer, manufacturer, and supplier of microfiltration and single-use systems, acquired PDC Aseptic Filling Systems, a supplier of aseptic filling systems and sealers (5). PDC’s products will add to Meissner’s current process solutions, which include filtration, single-us systems, fluid handling, and unit processing offerings. The filling systems enable automated aseptic filing of pharmaceutical process liquids, while the sealing equipment reduces cycle times associated with aseptic disconnections, according to the company.
ABEC, a provider of integrated solutions and services for biopharmaceutical manufacturing, announced the completion of its second ISO-compliant cleanroom for single-use disposable container manufacturing at its Fermoy, Ireland, facility in February 2018 (6).
The new Fermoy cleanroom will strengthen ABEC’s custom single run single-use product offerings and will be operational in April 2018, according to the company. The first cleanroom, located in Bethlehem, PA, has been fully operational since 2015. ABEC also announced large-scale single-use microbial fermentation capability using the company’s CSR technology with working volumes up to 1000 L (7).
1. F. Mirasol, BioPharm International 31 (2) 2018.
2. Watson-Marlow Fluid Technology Group, “Biopure Q-Clamp is Compatible with a Wide Range of Connector Geometries,” Press Release, Feb. 8, 2018.
3. Sartorius Stedim Biotech, “Sartorius Stedim Biotech Launches New Ambr 250 High Throughput Bioreactor System for Perfusion Culture,” Press Release, March 14, 2018.
4. Abzena, “Abzena Selects Sartorius Stedim Biotech to Equip its US-Based Development and Manufacturing Sites in San Diego and Bristol,” Press Release, Jan. 4, 2018.
5. Meissner Filtration Products, “Meissner Acquires an Aseptic Filling Company,” Press Release, Jan. 12, 2018.
6. ABEC, “ABEC Expands Manufacturing Capability of Single-Use Disposable Containers for Biopharmaceutical Manufacturing,” Press Release, Feb. 13, 2018.
7. ABEC, “ABEC Introduces Large-Scale Single-Use Microbial Fermentation Solutions to the Biopharmaceutical Manufacturing Industry,” Press Release, Feb. 28, 2018.
Vol. 31, No. 4
When referring to this article, please cite it as A. Lowry, "Single-Use Systems Advance Upstream Processing" BioPharm International 31 (4) 2018.