Biomanufacturing Innovation - Pharmaceutical Technology

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Biomanufacturing Innovation
Industry wants more innovation, but can suppliers meet customer needs?


PTSM: Pharmaceutical Technology Sourcing and Management
Volume 8, Issue 7


Eric Langer
The biopharmaceutical industry has a voracious appetite for new technologies that increase productivity and improve performance, a point confirmed by BioPlan Associates' annual survey on bioprocessing trends and innovation (1).

Bioprocessing innovations in demand


Figure 1: Select new product and service areas of interest, 2010–2012.
When asked about average budget changes from 2009–2012, those surveyed reported the highest budget increases were for new technologies to improve efficiencies and costs for downstream production (an average 6.4% increase) and for upstream production (an average 6.0% increase). For new products, the largest portion of respondents cited disposable bags and connectors (40.0%), followed by probes and sensors, (36.1%), chromatography products (32.2%), bioreactors (31.7%), and purification products (28.9%) (see Figure 1). Much of the interest in improved sensors, bioreactor, purification, and other equipment involves single-use applications. Only 10% of respondents wanted new stainless-steel equipment. In services, upstream process- development services topped the list.

The survey showed that a common cause for dissatisfaction with current single-use bioreactors, liners, and other equipment is they are not robust enough. Single-use equipment is still not adaptable to the more extreme mixing, heat, and other conditions involved with most microbial systems (e.g., E. coli and yeast).

When asked to rate the factors responsible for creating bioprocessing improvements in the past 12 months, the largest portion (72.6%) cited "overall better control of processes," followed by "improved downstream production operations," and "use of disposable/single-use devices."

Vendors' focus on R&D

To evaluate how well vendors' R&D match industry needs, the BioPlan survey asked about budget changes in 2012. Vendor respondents reported an average 1.9% increase in basic R&D for product development, a 2.4% increase for hiring new staff, a 4.3% gain in sales budgets, and a 3.4% uptick in capital-equipment purchases.


Figure 2: The top six new technologies being worked on by vendors, 2010 – 2012.
Survey data show vendors concentrating much of their R&D on improved and new single-use equipment (see Figure 2). The largest portion (46.2%) report working on bioprocess development/optimization services and bioprocess modeling, followed by disposable/single-use bioreactors and consumables, single-use bags and films, filtration, and chromatography products. Other examples of vendor R&D include: animal-free media components; bioreactor control; chromatography alternatives to Protein A; cell-line optimization; sensors and probes; culture-media optimization services; alternative mammalian-cell expression systems; monitoring systems; culture-media supplements; controller systems; impurities detection; bacterial expression systems; lyophilization; testing/assay services (e.g., raw materials, glycosylation, viral clearance, cell lines); and packaging materials.


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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
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Reducing drug shortages
27%
Breakthrough designations
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More stakeholder involvement
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Source: PTSM: Pharmaceutical Technology Sourcing and Management,
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