Bioprocessing equipment and materials, as well as technical discussions about process development, were in prominent positions at the INTERPHEX 2016 trade show, held in New York in late April. Rita Peters, editorial director of BioPharm International, shares some observations of announcements and activities at the event.
What developments with single-use systems were discussed?
There were several storylines about single-use systems at INTERPHEX. A number of equipment manufacturers announced new bioreactors, fermenters, tanks, and other process-related equipment as the move toward single-use systems in commercial manufacturing moves forward.
The progress is incremental, but is moving ahead. One sign of progress was the opening of a JHL Biotech flexible manufacturing facility in Wuhan, China on May 10, 2016, for the manufacture of biosimilars and monoclonal antibodies (mAbs). The facility, the first built using the KUBio system (GE Enterprise Solutions), was completed in 18 months. Parrish Galliher, chief technology officer, upstream, GE Healthcare Life Sciences, provided an overview of the KUBio facility and FlexFactory equipment at INTERPHEX.
Complexity and scale are two stumbling blocks to the implementation of single-use systems on the commercial manufacturing scale, reported 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.
Did you see any trends in the consumables segment?
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 for these vital materials. The new facilities offer operations that are similar to existing facilities; these redundant operations were developed to ensure a continuity of supply of vital materials in the event of manufacturing problems at another facility. In other cases, the expansions help place materials closer to customers in different geographic regions. 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.
What progress has been made in process development for continuous manufacturing?
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. 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.
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.
In the past year, consolidation of contract manufacturers made big news. What are the implications for drug license holders?
The contract services market—for both small- and large-molecule drug development and manufacturing—has restructured, as the larger contract service providers have made acquisitions to expand their capabilities into areas where gaps in service offerings existed previously. The larger contract service providers are positioning 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. Some contract service providers are currently ‘thin at the senior management level’ and integration with new assets can be challenging. Also, Miller warned that some contract service providers incurred debt as a result of acquisitions.