Aseptic processes are some of the most challenging processes to conduct in the pharmaceutical industry. Historically, drugs, biologics, and medical devices were manufactured to be safe, effective, and compliant with regulatory requirements to meet the objective of providing high-quality products and therapies.
However, it is no longer enough for today.
Today, life science products need to be affordable to patients and a reasonable business proposition for manufacturers. Hence, achieving this simultaneously proves to be a major challenge to manufacturers as they strive to gain both production and process efficiencies.
In the most basic form, managing sterile products and containers in a controlled environment where the air supply, materials, equipment, and personnel are regulated to maintain sterility is defined as aseptic processing in pharmaceuticals.
In aseptic processing, managing the high cost and sensitive nature of aseptic processes requires constant attention and maintenance. With the increasing criticality against patient safety, intense scrutiny of injectable drugs has been proposed by the Food and Drug Administration (FDA) and other agencies. Quality concerns have created a heightened demand for innovative solutions to reduce non-conformance.
Principles for Aseptic Process Improvement
The Parenteral Drug Association (PDA) task force made several improvements to altercate the challenges in modern sterile product manufacturing and distribution with aseptic processing.
Here are some guiding and linked principles for aseptic process improvement and efficiency that have been outlined for sterile health care products:
• Information required for making decisions related to the evaluation, design, qualification, operation, and monitoring of sterile product manufacturing must be obtained through science and risk-based approaches.
• Aseptic process technology should be integrated to mitigate and reduce the risk of product quality deterioration in sterile product manufacturing.
• Conventional testing and monitoring methods should be abstained, ensuring the best means for aseptic processes.
• New products, therapies, and technologies should remunerate traditional and existing methods for the development, manufacture, validation, and testing of sterile products.
• The technical and regulatory guidance and requirements presented by the global health authority should be harmonized with regard to technical language and definitions.
Considering these regulatory principles, the expected growth in the global pharmaceutical aseptic transfer market is to be driven by the significant expansion and rise in investment in the pharmaceutical industry. With the implementation of stringent regulations for drug approval processes and the growing demand for automated products, the aseptic transfer market is getting engaged in varied advancements in aseptic transfer processes.
According to a report by BIS Research, The global pharmaceutical aseptic transfer market is projected to reach $2.55 billion by 2031 from $855 million in 2021, growing at a CAGR of 9.61% during the forecast period 2022-2031.
Recent Compliance Trends in Aseptic Transfer Processing
There are many trends in compliance to expanding knowledge and continuing the conversation in this evolving field, some of which are mentioned as follows:
Case for Risk-Based Thinking: A rise in regulatory concerns over determining risk factors that challenge aseptic and sterile product processing has been witnessed in recent years. With this, the best available technologies leveraging science-based risk assessment compete for the need for a renewed emphasis on assurance and control checks.
In aseptic processing, it is difficult to establish the correlation between the observation and the desired outcome (sterility) or the undesired outcome (lack of sterility). So, monitoring can be done to provide indications of aseptic processing performance, but their cause and effects are never completely certain.
Need for Innovative Technologies: For the ineffectiveness of aging facilities and resultant drug shortages, the lack of innovation and technology adoption is increasingly being blamed. The continuous process manufacturing or rapid monitoring methods are yet to be embraced.
Some pharmaceutical companies remain reluctant to automate electronic record keeping due to concerns over the ability to validate such systems. As the lack of technology exists in manufacturing, regulators are unable to endorse and promote innovative means of manufacturing which stifles efficiency.
However, the incorporation of glove ports negates the benefits that the new technology promised to manage the complexities of a highly potent aseptic process effectively.
Evolution of Robotics in Aseptic Transfer Technology: Many machine manufacturing companies believe that aseptic processing has contributed a lot to product safety through the advancement of robotics technology. The future has become a reality and learning about new applications of aseptic systems can make a huge difference in the entire chain of processes, such as using a set of robotic arms to lift and transfer vials from a platform to the pharmaceutical.
Challenging Traditional Approaches: In the attempt to improve the technical aspects of aseptic processing, it must be ensured to not over-engineer the pharmaceutical industry with innovative robotics, which may cause a decrease in the real benefit and value of traditional medical approaches.
It is important to differentiate between the traditional approach of manufacturing pharmaceutical devices that require any modification and the approach that does not require any modification.
Consideration of New Therapies: Many of the standard guidelines, expert advice, and best practices for aseptic processing are based on large-scale manufacturing of replicate doses. The aseptic processing and manufacturing guidelines of sterile medicinal products were written for cell and gene therapy which may not suffice the current challenges of aseptic processing and patient needs.
Many medical products are manufactured using processes involving different risks and requiring different manufacturing processes and controls than large-scale, mass-produced medicines.
Though older techniques have proven as key elements of medical requirements yet cannot always be standardized, accomplishing innovative therapies is the need of the current pharmaceutical market. Hence, the need to adopt new technologies and therapy has become critical.
Conclusion
The pressure to cater to the high demand for drugs in a short span of time has invariably led to a higher focus on ensuring sterility, and aseptic processing ensures minimal drug wastage.
Additionally, the increasing demand for single-use aseptic transfer systems, rising demand for liquid aseptic transfer systems, and the integration of Industry 4.0 within the pharmaceutical aseptic ecosystem are some of the major opportunities in the overall pharmaceutical aseptic transfer market.
