Results and discussion
Characteristics of the products and sites.
The demographics of the 34 products included in the analysis are organized into the following groups:
Market(s) served:
- 29 of the products surveyed are marketed in the US; 24 in Canada; 33 in Europe; 26 in Japan; 17 in South America; and 20 in
Asia (outside of Japan).
Product and process:
- Product type: 27 of the products surveyed are therapeutic proteins; 12 are antibodies
- Processing: 25 of the products surveyed are produced by mammalian cell culture; 9 by microbial fermentation
- Complexity: 15 of the products are perceived as above average in process complexity
- Role of quality by design (QbD): 10 of the products are significantly impacted by use of a QbD approach.
Characteristics of the manufacturing site:
- Geographic location of commercial manufacture: 6 are based in in Asia; 12 in Europe; and 16 in the US
- Contract manufacturing: 14 of the products are manufactured in a site that does greater than 40% of their work as contract
work
- Other biologic products at the site: 15 of the products are manufactured in a site that also manufactures more than five biologic
products
- Use of third-party quality inspections: 24 products surveyed are manufactured in a site that has had multiple third-party
quality inspections (for practice) in the past five years.
Based on these overal demographics, the products in the MIT CBI survey represent a reasonably diverse set of biopharmaceutical
products, processes, and manufacturing sites.
Figure 1: Fraction of personnel associated with each of the technical areas at different sites. QA is quality assurance; QC
is quality control; ESS is engineering support and services; and TS is technical services. (ALL FIGURES COURTESY OF THE AUTHORS)
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Distribution of technical personnel within the manufacturing sites.
The distribution of technical personnel within a manufacturing site provides some representation of the priorities and/or
focus of the site. The sites reported the number of personnel in each of the following technical areas: quality control (QC)—average
12.6%; quality assurance (QA)—average 17.4%; engineering support and services average 8.8%; technical services—average 16.3%;
and manufacturing—average 44.9%.
Figure 2: Fraction of technical personnel in a manufacturing position across sites surveyed.
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A histogram with the fraction of personnel in each of the first four areas is presented in Figure 1. The histogram of fraction of technical personnel in manufacturing is shown in Figure 2. There is a wide distribution of where technical personnel are assigned within the sites (particularly visible from the distribution
of technical personnel in manufacturing) suggesting one or more of the following scenarios across the sites that completed
the survey:
- Different role definitions for personnel within the technical areas
- Structural differences between sites necessitating different distributions of personnel
- Different priorities and/or focus of the site management
- Lack of understanding regarding optimal distribution of technical personnel.
Figure 3: Experienced and expected drivers of quality activities and resources.
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Site-level drivers of change.
Each site was asked to identify significant sources, or drivers, of changes in quality efforts and activities at their site.
The respondents indicated whether specific drivers had been experienced by the site in the past and/or are anticipated drivers
for the site in the future. The results from the survey of the sites are presented in Figure 3, ordered from left to right
in descending order of fraction of sites identifying the type of driver as one that has been experienced in the past. Of particular
note are the following findings:
- The two types of drivers most frequently experienced were technical challenges (i.e., process, material, equipment) and regulatory
challenges (i.e., change from the regulator, noncompliance).
- Drivers potentially directly related to profitability of the product (e.g., cost reduction and pursuit of new markets) have
been infrequently experienced.
- Drivers expected to be experienced significantly more in the future than the past are those directly related to profitability
including pursuit of new technology, cost reduction, and pursuit of new markets.
- The number of types of drivers expected to be experienced per site is significantly higher than the number of types of quality
drivers historically experienced per site, increasing from an average of 40% to 60%. For example, sites expect to have more
drivers of change in quality approach and activities and/or have different outcome priorities (e.g., cost reduction and anticipated
regulatory change) in the future compared with the past.
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