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Advances in single-use systems, consumables, and continuous manufacturing show steady progress.
At the 2016 INTERPHEX show in New York City in late April, several storylines emerged about single-use systems, consumables, continuous manufacturing, and contract services.
The move toward single-use systems in commercial manufacturing moves forward; however, progress is incremental. Complexity and scale are two stumbling blocks to the implementation of single-use systems on the commercial manufacturing scale, according to participants in a panel discussion hosted by BioPharm International. The time needed to develop a process is often underestimated because the process is more involved than people expect. In addition, single use is not practical to use for very large volumes, such as 10,000 L; practical use of the system, versus volume, must be considered.
Testing of plastic components for extractables and leachables, as well as performance and consistency from multiple suppliers, was a popular topic. The need for harmonized standards was emphasized, but lacking any immediate consensus, the panelists recommended that drug companies take a risk-based approach to evaluating single-use system components and conduct supplemental testing to ensure the safety of their process systems.
The quality and supply of cell-culture media, buffers, and other process liquids was also a popular topic. Demand for custom formulations and packaging have increased, as has customer demand for quality control reports.
Several suppliers reported facility expansions to increase capacity and offer redundant operations to ensure a continuity of supply of vital materials in the event of manufacturing problems at another facility. Another trend is a shift toward in-line dilution and systems that provide access to large volumes of buffers without having to expand buffer storage areas.
FDA has aggressively been encouraging drug license holders to modernize manufacturing processes; continuous manufacturing is a key facet of those efforts. The agency has accelerated approvals of breakthrough drugs, but identified the need for earlier scale-up chemistry, manufacturing, and controls (CMC) work. Similar to the single-use system advances, continuous manufacturing for the production of biologics is showing some step-by-step advances, but still trails advances on the small-molecule market.
Equipment manufacturers displayed systems that fit process development and scale-up continuum that could help drug companies move forward in these efforts. Several equipment manufacturers displayed systems that could work in a progressive chain, eliminating some batch process steps.
Contract services consolidation
In recent years, large contract service providers have made acquisitions to expand capabilities to fill gaps in service offerings and position themselves as full-service providers, offering drug license holders the option of consolidating projects with a single provider. The one-stop-shop approach can offer drug companies simplicity in oversight and provider management, more flexibility in the type of manufacturing capabilities, and continuity benefits of having a project developed at a single source. The transition phase may be difficult for some newly merged contractors, however, said Jim Miller, president of PharmSource, in his annual report on the state of the contract services market, as they integrate new assets.
Vol. 29, No. 6
When referring to this article, please cite it as R. Peters, "Bioprocessing Technology Marches On," BioPharm International29 (6) 2016.