Biologics fill finish represent one of the fastest growing segments of the pharmaceutical industry. Over the years, these large molecules have demonstrated promising therapeutic outcomes in the treatment of myriad of chronic and challenging disorders, including autoimmune disorders, infectious diseases, genetic disorders, and oncological disorders. These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.
Further, the manufacturing of biologics fill finish is a highly complex and cost-intensive process. The production of biologics involves high degree of fragility and sensitivity involving the need for complex manufacturing capabilities, such as fermentation, aseptic fill finish, adequate storage with controlled temperatures and analytical testing to offer quality products. Additionally, the fill finish manufacturing of biologics is a critical step in the production of biopharmaceuticals as it requires well-equipped facilities with adequate sterile filling and packaging lines to ensure sterility of the product while filling into the final containers. It is worth noting that, any discrepancies encountered at this stage of manufacturing can lead to microbial contamination, subsequently resulting in loss of product, long development timelines and substantial financial burden for the drug developers, owing to the high cost of cell-derived raw materials.
Need for Outsourcing Biologics Fill Finish Manufacturing
The following points highlight the need for outsourcing biologics fill finish manufacturing operations to biologics fill finish companies:
- Fill finish expertise and capabilities for biologics, including high-speed filling lines, aseptic clean room, and maintenance of a sterile facility, is a capital-intensive process.
- Requirement of higher fill finish capacity and facility owing to the increasing demand for such drugs.
- Advanced and complex technologies such as automated filling lines, 3D vision cameras are required for fill finish, as well as release testing of biologics.
- Availability of innovative platforms / technologies with fill finish contract manufacturing organizations, such as SA25 aseptic filling workstation (developed by Cytiva), an isolator-based filling technology capable of filling primary packaging containers for large commercial batches of more than 20,000 units. Notable examples of fill finish manufacturing companies equipped with SA25 aseptic filling workstation include (in alphabetical order) Emergent Bioservices, PCI Pharma Services, Singota Solutions and WuXi Biologics.
The above-mentioned factors have compelled many small drug developers, as well as certain pharma giants in this domain, to outsource their fill finish operations to fill finish manufacturing companies. Further, it is worth highlighting that fill finish manufacturing is one of the most commonly outsourced operations in the biopharmaceutical industry, occupying about one-third of the total market. Drug developers prefer to outsource their fill finish manufacturing needs for several reasons. For instance, small biotech companies enter into agreements with fill finish manufacturing companies 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.
Advantages of Outsourcing Biologics Fill Finish Manufacturing
Outsourcing of biologics fill finish manufacturing has garnered significant traction in the past decade, owing to the regulatory approval of more than 130 biologics across various therapeutic areas.
The following figure presents the significant advantages of outsourcing fill finish manufacturing to fill finish contract manufacturing organizations.
- Reduced Capital Expenditure: Outsourcing fill finish manufacturing operations to fill finish manufacturing companies offer a cost saving potential for drug developers as it reduces the capital expenditure associated with the establishment of well-equipped filling lines, recruitment of trained personnels, and procurement of raw materials and packaging products.
- Access to Advanced Technologies: Partnering with fill finish contract manufacturing organizations allows the product developers to get access to various advanced technologies, such as robotics and artificial intelligence that automates the fill finish operations and results in efficient filling and contamination-free production of drug products.
- Well-defined Quality Control Setup: Engaging CMOs in the fill finish manufacturing aids the drug developers to meet the stringent quality standards as these organizations maintain well-defined quality control setup which is built in compliance to the regulatory guidelines offered by various organizations, such as ISO and FDA
- Operational Flexibility across different Scale of Operation: Partnering with contract service providers allows pharmaceutical companies to obtain fill finish manufacturing of drug products for various scales of operation as these organizations are well-equipped with the facilities as well as the workforce to handle both small and large-scale production batches.
- Minimized Risk of Contamination: Outsourcing a few operations of an industrial process enables developers to shift certain responsibilities to its partner. This ensures that a robust risk management protocol is adapted by the partner organization in order to handle the potential risk of contamination associated with the release of sterile drug products.
Challenges Associated with Biologics Fill Finish Manufacturing
Although outsourcing of fill finish services is supported by several advantages, there are several risk factors associated with the outsourcing of various operations to third party service providers.
The following figure presents the challenges associated with outsourcing biologics fill finish manufacturing.
- Loss of Managerial Control: After outsourcing a particular operation to a third-party organization, the 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 depends solely 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.
- Chances of 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 the capacity and financial constraints of the CMO partner, and the prioritization of certain high value contracts over others.
- Inefficient Management of Client 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.
- 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 such situations, it is difficult for the service provider to dedicate their complete focus to the needs of each client. Moreover, sponsor companies are unable to monitor such inefficiencies owing to lack of proper visibility on the CMOs’ operations.
Concluding Remarks
Over the past few decades, fill finish operations have transformed remarkably in terms of innovation, technology, and capacity, which has led to an increase in the growth of this market. In order to attract more stakeholders and attain a competitive edge, CMOs are expected to adopt new automation fill finish technologies and establish multi-product user-oriented facilities. With the current industry mainly focusing on quality and multi-product strategies, the trend to incorporate technologies, such as artificial intelligence and robotics will allow CMOs to obtain better efficiency and increased quality necessary to meet the ever-changing demand of the biologics industry. Other factors that could present opportunities for future growth, include establishing fill finish facilities in developing nations, utilization of complex administration techniques and improved product labelling to reduce counterfeiting.
For more details, you can also download the SAMPLE REPORT on Fill Finish Manufacturing Market by Roots Analysis.
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