From their humble beginnings as small-scale media storage and shipping containers, single-use disposable bioprocess systems have grown to encompass ever-larger bag sizes integrated with tubing, adapters, connectors, ports, automation, and sensors.
Acceptance of disposable products is growing among bioprocessors seeking to control costs and enjoy flexible manufacturing. Notable trends include:
Demand for larger disposable systems for mixing, processing, storage, and shipping. The largest disposable bioreactors contain about 2,000 L, although 5001,000 L is more typical.
Mixing, processing, and filling systems with greater functionality (i.e., inlets, connectors) and a high degree of integration.
Greater focus on film purity, especially with respect to animal-derived ingredients and components.
More diversity in designs of all types of bags, particularly for mixing and fermentation/cell culture.
Collaborations, mergers, and acquisitions, with the goal of offering complete, turnkey disposable systems for various unit operations, and, ultimately, for a completely disposable process.
Domination of the disposables marketplace by a few large companies, with perhaps 2030% of the remaining sales going to smaller firms and startups.
Development and sale of standardized bag designs to meet the market demands for predictable, reliable, and cost-effective disposable systems.
Greater focus on supplier agreements to maintain a reliable source of disposables.
Within five years, eighty percent of the disposables business will be held by a small number of large companies with deep pockets, robust R&D capabilities, in-house quality engineers, and large sales and marketing teams already focused on sterile bioprocessing, says Jerry Case, vp of business development at Newport Biosystems (www.newportbio.com).
According to Vijay Singh, Ph.D., president of Wave Biotech (www.wavebiotech.com), as biotech companies incorporate disposable bioprocessing into core manufacturing operations, users become more sophisticated about how equipment is manufactured, inspected, and validated. Vendors have responded by supplying prevalidated equipment, which shifts the regulatory burden away from end-users. For example, Wave Biotech has filed a DMF (drug master file) with the FDA that provides users with regulatory information for product and process registration.
One knock against disposable processing is the apparent upper size limitation for single-use cell culture bags. Disposable bioprocessing began to take off around the time that pundits were warning of dire cell culture capacity shortages and calling for construction of 50,000-L reactor tanks.
The shortages never materialized in any serious way, but perhaps more importantly, cell culture yields, process efficiencies, and product potency have risen steadily, rendering moot the question of bag volumes. Production that once took place in a 10,000-liter tank, in batch mode, can now be done in a 100-liter bag using perfusion culture and better-engineered cells, notes Dr. Singh.
Cost will continue to be a driver for adoption of disposable processing. Dr. Singh estimates that the nondisposable component of disposable system (in his case, the rocker table and instrumentation for the Wave Bioreactor) costs one-fourth to one-third as much as comparable reusable equipments (e.g., installed stainless steel stirred tanks), while the disposables themselves cost significantly less than the cost of cleaning, sterilizing, maintaining, and validating a steel bioreactor.
Paul Priebe, head of product management for disposable technology at Sartorius (www.sartorius.com), observed a distinct trend away from components toward disposable processing systems that can replace traditional process equipment.
This transition is occurring where disposables are being used for actual process steps, Priebe observes. Factors enabling this transition include development of efficient disposable mixing systems, the growing expertise among vendors and end-users alike, and expanded vendor services that routinely include regulatory support.
In other words, vendors of disposable products are catching up, in terms of support and the information they provide customers, with other suppliers. Filter suppliers have long provided the validation services required to implement the use of their products in cGMP processes, notes Priebe.