Imagine a major game designer developing a new video game that is comprised of pitfalls and complexities so numerous and difficult
that few players reach the midpoint, let alone complete the game successfully. This situation is analogous to the world of
biotechnology, where companies face this scenario regularly and must do everything possible to increase their odds of successfully
completing the "development game" and to reduce the risks of elimination. The risks and rewards of playing the game are high
but few can afford to fail, even once.
Biotechnology projects are complex and subject to many levels of risk during the early clinical phases. Few products enter
Phase III, and fewer still make it through approval and on to commercial manufacture. Furthermore, globalization and other
recent developments, such as tighter quality control criteria, evolving technologies, and the increasing stringency of regulatory
standards, have imposed enormous pressures on an already difficult task of taking a product to market.
The primary concern in most instances is to maximize the value of the compound in the earliest stages of development to assist
in attracting investors, provide outlicensing opportunities or in some cases, allow outright acquisition by a larger company.
To such companies, little thought is given to later development or the commercialization efforts that must be applied to the
compound or the myriad of interfaces between various partners that might be necessary as they move forward with a project.
FINDING THE RIGHT ANSWERS
In clinical development, finding answers—the right answers—is anything but simple. There are many questions, many unexpected
challenges, and many decisions that all need to be carefully and thoughtfully addressed because of their potential impact
on the product's success.
Successfully conducting a clinical development project requires a biotech company to:
- Ensure packaging material compatibility
- Develop novel, efficient process solutions
- Solve lyophilization problems, if relevant
- Ensure consistent batch quality
- Meet crucial deadlines for clinical trials
- Expedite regulatory approvals
- Streamline scale-up to commercial manufacturing.
This article focuses on a few of these steps.
Finding the right solution to specific problem starts with a clear understanding of a compound's underlying technical and
scientific requirements. Compounds are becoming more complex and that means greater demands on primary packaging. Highly sensitive
drugs, including biopharmaceutical ones, require optimally designed drug-delivery systems. In addition to technical challenges,
there are growing cost pressures and increasingly strict rules from regulatory agencies. Therefore, drug manufacturers need
a great deal of competence when calibrating packaging with the drug product. On one hand, there is the compound itself and
its environmental conditions (e.g., reaction with certain materials, biological specifications). On the other hand, time factors
(e.g., time-to-market) and long-term market success (e.g., product life-cycle management) are important criteria to consider.
Among other things, companies must ask—and answer—the following questions:
- Is the drug product compatible with rubber stoppers, closure systems, and other related components?
- How much silicon can the substance endure?
- How can the silicon be applied to the interior panels of the system (e.g., spray siliconization or baked silicon)?
- What materials are suited for the components (e.g., rubber formulation)?
- Do the components have to be pretreated (e.g., teflon-coated stoppers)?
- How is the substance's break-loose and glide force behavior?
- What materials are compatible for add-on systems, such as safety devices?
- What washing procedures are necessary?
- How should sterilization be performed?