The biopharmaceuticals market, characterized by a robust and promising pipeline, currently represents one of the fastest growing segments of the pharmaceutical industry. Over the years, there has been incremental evolution of concepts and methods, which have facilitated various advances in process technologies for the development of increasingly complex biologic products. Despite the fact that biopharmaceuticals offer significant profit margins and have been proven to be effective in treating a myriad of disease indications, these therapeutic products are generally known to be associated with high costs of development and complex manufacturing protocols. Over time, this high-value sector of the pharmaceutical industry has captured the interest of many stakeholders and has grown to acquire a large share in the overall pharmaceutical development pipeline.
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Biopharmaceuticals are expected to continue to provide significant growth to the pharmaceutical sector over the next five years. The market share of biologic products is expected to increase up to 23% till 2021. As a consequence, the biopharmaceutical contract services market has witnessed rapid growth in the recent past. Over the course of the next few years, the contract services market is anticipated to grow at an annualized rate of 8.3%. It is worth mentioning that bioassays, toxicity testing, fill / finish operations and validation processes represent the four most heavily outsourced operations. Specifically for fill / finish operations, it is estimated that about a third of such activities are presently outsourced by drug manufacturers.
Fill / finish is the final step in downstream processing of a product, wherein the purified bulk formulation of the biopharmaceutical is mixed with the necessary excipients and stabilizers and formulated and aliquoted into the appropriate dosage forms for clinical use or commercial distribution. These operations are usually carried out under aseptic conditions and are mostly automated. Unit operations involved in the fill / finish process include compounding and mixing, filling, lyophilization, closing and sealing, sorting and inspection, and labelling and packaging.Specifically, for biopharmaceuticals, special procedures and equipment are required during fill / finish process to ensure product integrity. These operations are required to be designed in accordance with the innate properties of the proteins so that the external factors do not affect their behavior and stability. Specifically, the three-dimensional structure of biopharmaceuticals, such as proteins, needs to be preserved during fill / finish operations. In addition, at high concentrations, the protein-protein interactions lead to a significant increase in the viscosity of the bulk drug substance (BDS). This reduces the manufacturability of the product and complicates the delivery of therapeutic. Owing to this fact, manufacturers prefer freezing their BDS before transferring to the fill / finish facility. The process reduces the risk of microbial contamination, as well as increases the stability of the drug product for longer time periods.[1], [2]
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Companies outsource their biologics fill / finish operations for various reasons. For instance, small biotech companies enter into agreements with fill / finish service providers due to lack of in-house capacity. For companies with in-house fill / finish capabilities, the outsourcing strategy is more complex and depends on a number of factors, such as phase of product development, product life cycle, production volumes and profitability. However, one of the major drivers for outsourcing fill / finish operations of biopharmaceuticals is to gain the additional capacity or capability and reduce the risk profile by sharing the overall cost of development.[3]
The complete development of a biopharmaceutical product is a multifaceted procedure and selecting a suitable CMO for outsourcing fill / finish operations is one of the main challenges for biopharmaceutical companies. Errors at this stage could lead to product failure and cost the manufacturer millions of dollars of investment. Despite the cost benefits that fill / finish contract service providers offer and their extensive technical capabilities, there are several parameters that need to be considered while selecting a CMO partner. The selection of a wrong / improper CMO partner can prove to be disastrous in the long run, when issues, such as delays and cost overruns, crop up.
Owing to the presence of numerous contract manufacturers that offer a variety of services across different therapeutic modalities, indications and regions, with varying strengths and capabilities, it is important for product developers to identify and select the best CMO to suit their demands.
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