The debate continues over the use of disposables in biopharmaceutical manufacturing, with firms considering the convenience,
cost, and the environmental impact of single-use, largely plastic, components. Anecdotally, it seems the industry is increasingly
embracing disposable components. Yet our survey indicates an insignificant increase in the number of respondents using all-disposable
systems—9% this year versus 8% last. Hybrid systems, which combine stainless and disposable components, remains the most popular
choice, but the 66% of respondents using hybrid systems represents a notable decline from last year's 72%, which was down
from the previous year's 74%. The use of stainless components continues to rise—26% of respondents this year report using
all stainless equipment, an increase over last year's 20%. Interestingly, 11% of respondents who now use hybrid systems say
they plan to convert to fully disposable equipment in the coming year, while no respondents anticipate moving to an all-stainless
system. No companies with revenues above $5 billion use completely disposable systems; 88% of respondents from companies with
revenues in excess of $50 billion use hybrid systems.
Table I: What is (are) the greatest advantages to disposable equipment? (Multiple answers allowed)
As in years past, we detected some marked differences in perceived advantages and challenges with disposable equipment among
users of that equipment versus non-users. The first discrepancy arises over the question of cost savings. Thirty-five percent
of all-stainless users (and 31% of hybrid users) believe there's a cost advantage to all-disposable systems. In contrast,
54% of all-disposable users say cost is an advantage to all-disposable systems, suggesting users of the other two systems
underestimate the savings to be gained by an all-disposable system. Those who use all-disposable systems also perceive disposables
to be more environmentally friendly (23%) than do all-stainless users (15%) and hybrid users (10%). All-stainless users also
underestimate process consistency that can be achieved with all-disposable equipment, as only 18% of stainless users cite
this as an advantage, contrasted with 31%, who actually use all-disposable systems. Additional responses suggest it may be
easier to incorporate automation and may have greater regulatory acceptance than all stainless users might think.
These same discrepancies arise when respondents were asked about the challenges inherent in single-use technologies. Users
of all-stainless equipment overestimated the cost, risk of contamination, and process inconsistency, compared with respondents
who use all-disposable equipment. On the other hand, all-stainless users underestimated the difficulty of incorporating process
analytical technologies, implementing QbD principles, and the risk posed by extractables and leachables. In addition, users
of hybrid technologies reported having greater challenges gaining regulatory acceptance (12.4%) than did users of all-disposable
equipment, none of whom (0%) reported this as a challenge.
Table II: What is (are) the greatest challenges to disposable equipment? (Multiple answers allowed)
The percentage of respondents who say their companies outsource the manufacture of biologics rose again slightly this year
over last year (36% this year versus 33% last), which represented a small rise over the previous year (30%). The reasons for
outsourcing seemed to have changed slightly from last year's reasons. This year, 51% of respondents say their companies outsource
to compensate for no or limited manufacturing capacity, whereas only 45% gave this reason last year. The percentage citing
cost effectiveness climbed this year, to 49%, up from 41% last year. Companies with revenues under $10 billion are most likely
to outsource, and their reasons for doing so differ, as well. A greater percentage of respondents from companies with revenues
under $5 billion outsource because they have no or limited manufacturing capacity (for example, 71% of respondents from companies
with revenues between $1 billion and $5 billion give this as the reason). Companies with revenues greater than $5 billion
outsource to realize cost savings. Smaller companies—those with revenues under $500 million also say they lack the expertise
internally (up to 75% of respondents from companies with revenues under $250 million, as opposed to 33% from companies with
revenues between $5 billion and $10 billion).
Overall, 61% of respondents say they outsource the manufacture of clinical-trial materials, and 49% said they outsource the
manufacture of both drug substance (APIs) and finished drug product. Thirty-three percent outsource the manufacture of drug
substance only, and an equal percentage (31%) said they outsource process development and full commercial-scale manufacture.
The functions least likely to be outsourced were drug product only, and formulation development (29% each). There were no
clear-cut patterns when it came to the size of companies and the functions they outsourced. In general, companies with revenues
under $500 million were more likely to outsource process and formulation development, than were companies with larger revenues.
Whereas companies with revenues above $500 million were more likely to outsource the manufacture of both drug substance and
drug product than were smaller companies.
Table III: Challenges according to protein class.