As the pharmaceutical sector has evolved over the past several years, the concept of vertical integration has gradually eroded. In fact, the industry has witnessed a paradigm shift from vertically integrated business model to a network of suppliers in order to reduce costs and improve efficiency. Over time, pharmaceutical players have started leveraging services of third-party service providers to meet their fundamental needs and specified competencies, while complying with stringent regulations. As a result, outsourcing has increasingly gained prominence in the industry, especially for manufacturing and fill / finish operations. Specifically, the fill / finish of drugs is one of the most crucial operations in drug development and manufacturing, as any error at this stage could lead to batch failure. Presently, contract fill-and-finish services are among the most outsourced services in the pharmaceutical domain. Almost every pharma and biotechnology company outsource a major portion of their fill-and-finish needs.
The contract fill / finish market in the pharmaceutical domain is characterized by the presence of both niche specialty companies, focused on filling and packaging of biologics and small molecules, and one-stop-shop CMOs that have, over time, acquired an extensive range of capabilities in order to cater to all product development and commercialization requirements of their clients. This chapter provides an overview of the types of drug products, commonly outsourced operations in the pharmaceutical development industry, and the benefits and risks associated with outsourcing fill / finish operations. The global aseptic fill finish manufacturing market is anticipated to grow at a CAGR of around 9%, till 2035, according to Roots Analysis. Driven by the consistent initiatives being undertaken by companies in this industry, the aseptic fill finish manufacturing market is anticipated to grow at a steady pace, over the forecast period.
ASEPTIC FILL / FINISH OPERATIONS OVERVIEW
Fill / finish is the final step in downstream processing of a product, wherein the purified bulk formulation of the drug product 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 drug products, 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 drug product so that the external factors do not affect their behavior and stability. This reduces the manufacturability of the product and complicates the delivery of therapeutics.
ADVANTAGES OF OUTSOURCING FILL / FINISH OPERATIONS
CMOs offer a number of benefits. Some of the main advantages of partnering with such third-party service providers are mentioned below:
- Cost savings: Companies that partner with service providers need not invest in establishing new fill / finish facilities, employing, training and maintaining a proper workforce. A number of companies outsource their fill / finish process to contract service providers based in developing countries where skilled labor is available at a low cost. Additional cost benefits are derived from economies of scale. In other words, since service providers work with multiple consumers at any given time, they are able to procure raw materials involved in packaging and labeling at a low cost since they buy it in bulk. This further enables them to produce the final product at reduced rate.
- Access to advanced capabilities and technologies: Partnering with fill / finish service providers grants customers access to capabilities and technology platforms, that demands huge investments in the manufacturing process. However, service providers already have expertise and well-established facilities to handle manufacturing processes at full scale.
- Validated quality control setup: Contract service providers are usually equipped to produce products that are compliant to guidelines set by different regulatory authorities, across the globe. It is, therefore, very likely that they have stringent quality control protocols in place. Hence, it is easier for a company to rely on the expertise of a third-party manufacturer rather than establishing and validating their own processes.
- Operational Flexibility: It is one of the key benefits offered by contract service providers. Organizations offering fill / finish services at a contract basis have the required capabilities to handle small and large-scale production batches. Hence, it is easier for a pharmaceutical company to deal with the same contract service provider for the fill / finish of their drug products.
- Risk sharing: One of the crucial factors determining the net outcome of any industrial process is risk-analysis. Outsourcing few components of an industrial process enables developers to shift certain responsibilities to their partner. In other words, this further ensures that the associated risk is shared by both the companies.
RISKS AND CHALLENGES ASSOCIATED WITH OUTSOURCING FILL / FINISH OPERATIONS
Some of the likely concerns that need to be addressed before the decision of outsourcing is made by a developer company are highlighted below:
- Loss of managerial control: After outsourcing a particular operation to a third-party organization, a biopharmaceutical company often stands to lose a significant amount of control over the process. This includes the loss of direct command over the manufacturing facilities, which leads to limited visibility and control over the product.
- Loss of intellectual property: Upon outsourcing, the customer is required to divulge a considerable portion of its intellectual property, in terms of development formulas, technologies and protocols, to the contract service provider. The protection of this confidential information solely depends on the integrity of the service provider.
- Quality concerns: Quality management is one of the most desirable traits that the customer looks for in a contract services provider. In order to ensure that this critical aspect is maintained, the pharmaceutical company should carry out a detailed evaluation of the quality control and quality assurance departments of the CMO partner(s) that it chooses to work with.
- De-prioritization: Usually, CMOs are involved in multiple projects and agreements with different pharmaceutical companies. It may happen that a pharmaceutical company may find itself de-prioritized over other companies; this can happen due to several reasons, including capacity and financial constraints of the CMO partner, and the prioritization of certain high value contracts over others.
- Relationship: It is very important for a pharmaceutical company to maintain a healthy work relationship with its CMO partner. Practices such as forcing the contract manufacturer to fulfill project goals can strain the relationship between the client and the service provider, which may prove to be disadvantageous in the long run.
- Risks of outsourcing to emerging nations: Low production cost is one of the major reasons that has made outsourcing to developing countries quite popular. However, the concept brings along a number of complexities in the management of outsourced contract manufacturing projects in offshore locations. Some of the risk factors involved in offshoring such operations include language barriers, and cultural differences that may impact performance and communication.
- Hidden costs: Sometimes signing contracts across international boundaries can pose serious threats of the involvement of hidden costs.
- Lack of customer focus: In certain cases, contract service providers are not in direct contact with sponsor companies, and there are times when such players are catering to the needs of multiple customers at a given point in time. In such situations, it is difficult for the service provider to dedicate time to properly focus on the needs of each client. Moreover, sponsor companies are unable to monitor such inefficiencies owing to lack of proper visibility on the CMOs’ operations.
Over the past few decades, fill / finish operation has largely stabilized in terms of innovation, technology, and capacity, which has flattened the growth of the market. In order to attract more stakeholders and attain competitive edge, CMOs are expected to adopt automated fill / finish technologies and establish facilities that have the capability to process various types of products. With the current industry mainly focusing on quality and multi-product strategies, this aforementioned trend is likely to emerge over the coming years. Other trends that could present opportunities for future growth include establishment of fill / finish facilities in developing nations, utilization of complex administration techniques and improved product labeling to reduce counterfeiting.
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