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Overcome challenges and discover how to maximize small-batch drug production
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By Matthew Gorton, Vice President of Business Development, Tacoma Automated Systems
The focus on drugs for certain patient niches has led to an increase in small-batch production across the pharmaceutical industry. These products include advanced therapy drugs (ATMPs) and high-value biologics, which require production with very complex processes or the use of expensive active pharmaceutical ingredients (APIs) that are often in limited supply. A minimum quantity available presents major challenges in the process of filling a product, making process efficiency a critical factor in reducing waste and improving yield for small batches of medicine.
The Manufacturing Requirements for Small Batch Production
Product loss is inherent in biologic drug manufacturing, particularly during sterile filtration, when the drug substance is trapped in filters and tubing during the final manufacturing phase. Minimizing loss during this phase is crucial in the manufacture of any medication, but it is especially important in an environment where you are working with a limited amount of product. Throughput should be considered at every step to ensure you can meet your clinical and business demands. Accuracy also plays an essential role, as overfilling or underfilling vials can result in a lack of product for proper final dosing. The implementation of automation and robotics is becoming a common attribute in facilities where there is an increased focus on reliability, accuracy, and process optimization. The flexibility that robots offer can help customers achieve greater speed to market. At the same time, the capabilities of an automated system can also lead to other benefits, such as improved throughput and accuracy. The ability to replace manual processing – which is highly labor-intensive, error-prone, and risky – with automated technologies that can perform reliable and repeatable process steps, is key to success in small-batch production. Reducing human intervention also mitigates contamination by removing the most common source of contamination – the operator – thus protecting the integrity of your product.
Planning for scale-up
Innovation in drug development typically begins in academic research and development laboratories. Once discovery turns into testing, increasing quality, preparing documentation, choosing the right format and dosage, becomes increasingly important. During this stage, it’s critical to plan for the future sizing of your process. Drug developers face great pressure to get their products to market quickly. If they wait to invest in automation until their process is fully understood, they will likely slow down the process of marketing a drug due to long lead times for fill finishing systems. Instead, it’s important to take steps to prepare for automation by requesting a system that is flexible enough to allow your process to evolve without limitations, often imposed by equipment that doesn’t easily adapt to process changes.
A commonly used strategy is the acquisition of less automated machines, available with shorter delivery times. This can help increase speed to market and conduct clinical or stability studies as you begin to plan for future expansion, with robotic systems designed for larger volumes, reliable, and flexible, but which have longer lead times. This approach model allows for better planning and understanding of capacity and time needs. AST’s systems provide direct technology transfer, which means that if you develop your process on a less automated machine, you can easily transfer it to a larger robotic AST platform. [/vc_column_text][vc_single_image image=”5417″ img_size=”large” alignment=”center”][vc_column_text css=”.vc_custom_1607350147961{padding-bottom: 20px !important;}”]
The need for flexibility
Flexibility is a major benefit of automation and robotics during small batch productions. For example, as more information about a therapy is collected and analyzed during process development, and even when clinical trials or new dosage formats become available, the requirements for manufacturing that product may change. It is important that you have equipment that can adjust to these needs, which often occur at later stages of development where the costs and risks are higher. This will help you overcome technical and strategic challenges quickly and efficiently, avoiding costly delays. During process development, formulation experts and engineers must work together to mitigate any potential risks that could complicate a product transition from benchtop to commercial scale. Many companies opt for strategies that allow them to learn about their new products and dosing systems in parallel with the initial phase of work, while the largest investments are being planned to meet projected needs and capabilities. Making sure that these small batch systems offer the flexibility to adjust to any changes in process and packaging materials while achieving a high throughput, assessing yield loss through quality sampling, etc. can be very important to ensure that you maintain the highest degree of agility in the future. In addition, automated solutions can record and document data during process development steps, as well as create electronic batch records (RELs) during production runs. These features allow you to better understand the critical quality attributes of your product and analyze different variations that can help in the process. Once the process is understood, the process settings are written to a controlled recipe. When a batch is started, the system will automatically follow the recipe and ensure that these parameters are used, and the REL will document that the defined process is followed. The information captured is documentary proof that the manufacturing process has followed all approved and validated steps. When adding automation to your operations, you must find the balance between equipment, costs, and space. The system you choose must ensure high throughput, process repeatability, product quality, and system reliability. AST equipment fits perfectly with all customers, in accordance with their needs, their environment and their long-term resources. AST’s GENiSYS® Lab systems are designed to produce semi-automatically, meaning machines perform critical process steps in an automated manner, while operators are also responsible for moving a vial manually between processing equipment. As an intermediate step, GENiSYS C can increase the degree of automation with only a small additional investment. It is a filling and closing system for automated processing of vials, syringes and cartridges in nest, which is robust yet small enough to fit into a minimum of existing space.
The operator uses a simple tool to transfer the nest to the filling without breaking the tightness, but the machine does the filling, closing and sealing. Regulatory agencies continue to push the industry to adopt advanced barriers against airborne contamination, such as isolators and RABs. In this case, robotics offers a major advantage by reducing human interaction during setup procedures and the production process. AST also offers two modular lines that are fully robotized and can be installed and integrated normally in insulators or RABs.
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Finding the right supplier
For small-batch production, it’s best to look for suppliers who are dedicated to the challenges you face, especially when it comes to small-batch manufacturing. Start first with those vendors that offer tailor-made solutions for your processes. Initial negotiations should include questions such as machine capacity and capabilities, as well as the manufacturing process and the specific needs of each product to be filled. They must understand all aspects of their long-term goals to determine which parts of their process should be automated.
Some questions may include:
- What kind of products are you working with?
- What batch size will you need to meet clinical demand?
- Do you already have a facility available or are you going to build one?
- What kind of containers will you use?
- What is your timeline?
- What is your expansion strategy?
- What stage of manufacturing are you in?
- Which markets are you targeting?
The answers to these questions, combined with discussions with AST experts, can help identify the best strategy for your project. This includes whether your system needs to be semi-automatic, fully robotic, or with a combination of both. As well as understanding when a system needs to be fully flexible or if it should be designed around a specific timeline and budget. Many of these projects also have schedule constraints. In these situations, it is important that you look for a partner that has, in addition to effective services, a culture of communication and collaboration with your customers. Knowing the team responsible for project management well is also extremely important. At AST, the project management team excels at understanding their clients’ vision, collaborating precisely in building the best path to mutual success. Overall, as the pharmaceutical industry continues to evolve, small-batch production will play a critical role in the future of modern medicine. Securing the right partner and equipment to meet your current need, but also one that easily adapts to your future demands, will serve as a key factor in remaining competitive in this ever-changing market.
About AST
AST (www.ast-inc.com), located in Tacoma, USA, has more than 50 years of experience in the design, manufacture and maintenance of innovative, highly skilled and automated processing equipment. For more than 10 years, since the launch of ASEPTiCell®, AST has been a leader in providing the most modern and safe solutions for the packaging and packaging – on a small and large scale – of sterile products. Using robotics and advanced automation, ASEPTiCell® was the industry’s first robotic aseptic processing system capable of processing vials, syringes and cartridges in a single system, decreasing the amount of equipment to be used in production and, consequently, reducing its investments in the construction and maintenance of clean rooms. [/vc_column_text][vc_column_text css=”.vc_custom_1607348057252{padding-bottom: 20px !important;}”]
For more information about AST’s complete line of filling machines, please contact us at contato@steq.com.br.
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