graph are possible along with the use of selective membranes and monolithic structured for Tangential Flow Filtration (TFF) processes. Advances
may also be seen in non-chromatographic methods such as highly selective precipitation of protein specifics. Advances will also be seen in automated, multi-batch processes using smaller disposable columns.
• Platform Technologies – As the industry’s experience with manufacturing
processes increases, platform technologies for a number of unit operations are being developed and marketed. These platform technologies,
some based on well developed proprietary technology, will provide significant enablers for future improvements. Notable platform technologies are being seen in cell/bioreactor systems and purification platforms.
• Process Equipment – Advancements are being seen in equipment and
equipment components unlike any time in the past decade. In particular,
the increase in single-use systems (SUS) or disposable components are
being developed and implemented in a much broader range than ever
before. SUS provide a significant advantage in reducing cleaning, sanitization, and sterilization development and validation requirements. SUS also
provide significant opportunities to isolate the process from the surrounding environment enabling a wide variety of opportunities in facility and
process designs. In addition, advances in equipment designs in bioreactor
configurations, centrifuges, and TFF units, are enabling a variety of process
and facility modifications that enhance flexibility and improve utilization.
• Automated Systems – A wide variety of software and support hardware
systems are becoming available to implement improvements in infrastructure systems. These include Manufacturing Executions Systems (MES),
Electronic Batch Records (EBR), and Laboratory Information Management
Systems (LIMS) to name a few. These computer technologies enable many
significant enhancements to the drivers and reduce risk uncertainty.
• Single-use manufacturing systems continue to make their presence
felt in preclinical and clinical manufacturing. Their increased use in
commercial scale manufacturing, while still small compared to traditional stainless-steel based systems, is leading to the advancement
of new hybrid facility models that will change the way companies
repurpose existing capital assets for use in the coming decade. With
these advances will also come the challenge of standardization while
addressing risk to the product during manufacturing. System closure
and equipment reliability will continue to improve. Novel platform
technologies for products such as vaccines will reduce costs while
increasing availability of therapeutics to a wider population.
Time is money. Speed is necessary to address demand. The Facility
of the Future is now the Facility of Today. Flexibility, adaptability, and
clonability are now necessities, not futuristic ideas that were once limited by the design and construction of manufacturing facilities. The
Biomanufacturing Industry of 2013 is a different animal than it was 30
years ago. The integration of technology into defining facility attributes
to produce advanced project delivery solutions relies heavily on technology that was non-existent just five years ago.
A number of facility design options are being discussed in different
global industry forums. A variety of facility design and layout options
are now possible that improve adaptability and flexibility. These in
include processes that share common space in a “ballroom” or large
general operating areas and more segregated, “matrix” approaches.
In addition, modular construction techniques exist for building facility
components remotely and assembling them on-side in near “ready to go”
Thermo Fisher Scientific.