Sterile manufacturing and aseptic processing are important in pharmaceutical manufacturing. To gain a perspective, Pharmaceutical Technology conducted a survey to gauge investments in manufacturing capacity, outsourcing practices, the level of innovation, and the
influence of quality by design (QbD). The survey found a fairly strong level of investment in sterile manufacturing and aseptic
processing in 2008 and slightly lower levels planned for 2009. Respondents were almost evenly divided in their decision whether
to keep manufacturing in house or to outsource and were generally satisfied with the level of innovation in equipment and
machinery. And QbD is playing a significant role in companies' sterile-manufacturing practices.
More than half, or 58.3%, of respondents said that their companies added capacity for sterile manufacturing or aseptic processing
in 2008 (see Figure 1). Almost 40% of respondents said that their companies were planning to add capacity in 2009 or 2010
(see Figure 2).
For those companies that added capacity in 2008, 46% added capacity for finished-product manufacturing. Fifteen percent increased
capacity for drug-substance manufacturing, and 39% added capacity in both areas. A similar distribution holds for companies
planning to add capacity in 2009 or 2010. Of those companies, 44% plan to add capacity for both drug-substance and finished-product
manufacturing. Thirty-nine percent will add capacity for finished-product manufacturing only, and 17% plan to add capacity
for drug-substance manufacturing only.
The overwhelming majority of respondents did not have capabilities for sterile manufacturing or aseptic processing for cytotoxic
or high-potency products. Approximately 62% of companies responding to the survey did not perform sterile manufacturing or
aseptic processing of these products, and 38% did (see Figure 3). Of the companies that did not perform cytotoxic or high-potency
manufacturing, only 13% were considering adding this capability.
Respondents were almost evenly divided regarding whether they kept sterile manufacturing or aseptic manufacturing in house
or outsourced. Forty-eight percent of respondents said that their companies outsource sterile manufacturing or aseptic processing,
and 52% do not outsource (see Figure 4). Of those companies that do outsource, 57% outsource both drug-substance and finished-product
manufacturing (see Figure 5). Thirty-three percent outsource manufacturing for finished products only, and 9% outsource only
The number one reason for outsourcing is companies believe that it is more cost-effective than producing a product internally.
Almost half of all respondents, or 47%, said that outsourcing was more cost-effective than captive production. The other reasons
for outsourcing are limited or no internal manufacturing capacity (39% responded thus) and an increase in projects requiring
sterile manufacturing (35% responded thus).