In the new millennium, the biopharmaceutical industry has undergone a significant transformation in all areas of business.
Blockbuster drugs, the foundation of the biologics revolution, are becoming increasingly rare. Many companies have experienced
considerable setbacks within their clinical-trial programs. As a result, biopharmaceutical executives are faced with the ever-present
dilemma of optimizing investment opportunities focused on advancing as many clinical prospects as practically and financially
feasible. Focusing on medicines for broad patient populations no longer guarantees business success. Therefore, companies
are identifying techniques and approaches that give an edge to the potential approval of a clinical candidate. One such approach
is the use of translational sciences, particularly biomarker research. One outcome of using this novel approach is the development
of more personalized, targeted medicines serving smaller patient populations.
CURRENT PRESSURES ON FACILITIES
The integration of biomarker data into the development process potentially promises less risky clinical-
trial programs and the opportunity to deliver product portfolios with greater chances of approval. However, the pursuit of
multiple, lower-volume biological products represents a challenge to a company's short- and long-range manufacturing strategy.
In an industry where competition creates pressure to lower cost, increase efficiency, and avoid capital investment, shifting
from fewer, high-volume products to multiple, low-volume products represents a hurdle for companies with existing large-scale
commercial facilities. How can a company maximize its current manufacturing capacity to meet a new business model that requires
higher utilization rates and the accommodation of multiple product mixes? In other words, how can we get more from what we
Meeting this challenge requires collaboration between development and manufacturing functions far earlier in a product's development
cycle to ensure manufacturing success. Completing a broad-based "Facility-fit Analysis" is important for providing an organization
with an enterprise view of its manufacturing operations. The analysis is an efficient and cost-effective way to address challenges
within the existing facility structure and allows a company to meet its changing business requirements in the most flexible,
MedImmune's Frederick Manufacturing Center (FMC), located in Frederick, Maryland, offers one example of how a
facility-fit analysis has helped the company create an operation geared towards greater flexibility. As the flagship manufacturing
asset for MedImmune, FMC, in collaboration with its process development partners, is working to tailor production processes
to efficiently fit the current infrastructure of the plant. To understand how the facility-fit analysis is improving the company's
business operations, below is a brief history.
MEDIMMUNE'S FMC FACILITY
The first manufacturing building (B636) at FMC was constructed in the mid-1990s and commissioned to manufacture Synagis (palivizumab),
a monoclonal antibody. Building 636 has 2 × 2.5k L bioreactors and associated proportional downstream purification capacity.
The FMC was expanded in 2006 with the initiation of construction for B633, a large-scale (4 × 15k L bioreactors) mammalian
cell culture-based commercial production facility initially designated for the manufacture of a mix of products in the pipeline
at the time. As part of the design, MedImmune introduced a degree of flexibility to the facility, enabling it to potentially
accommodate a range of product titers.
But one year after groundbreaking, the shape and magnitude of MedImmune's pipeline changed significantly. That same year,
AstraZeneca acquired MedImmune and integrated the capabilities of Cambridge Antibody Technology (CAT), which AstraZeneca had
acquired in 2006, into MedImmune's existing R&D infrastructure. Seemingly overnight, MedImmune's investigational pipeline
jumped from approximately 40 candidates to more than 120 candidates, resulting in a fundamental shift for FMC from a single
commercial product facility to a clinical and commercial multiproduct facility.
Addressing this situation required the company to overcome three key challenges as described below.