Udo Losehand, head of Global Technical Developers at Roquette looks at the benefits precision dispensing technology can offer biopharma manufacturers thanks to its versatility and customisability.
Precision
Thanks to the ever-increasing demand for its services, the biopharmaceutical industry has found itself at the center of global attention and is growing every day. The far-reaching effects of the Covid-19 pandemic have left biopharma manufacturers under increasing pressure to bring quality lifesaving drugs to market faster. It is this pressure that is driving demand for rapid innovation and the simplification of complex workflows – all while maintaining safety and reducing costs. This is no easy task, especially when handling complex raw materials.
As a result, single-use bioprocessing technologies have risen to the fore as a means for biopharma manufacturers to adopt new setups. These single-use systems have become an important tool for the industry – helping to streamline complex workflows, while offering the flexibility needed for on-demand and fluctuating capacity requirements; enabling manufacturers to keep pace with the ever-changing landscape.
What are single-use systems?
Single-use technologies come in all shapes and forms from tubing, capsule filters, ion exchange membrane chromatography devices, bioreactors and product-holding sterile bags, to connection devices and sampling receptacles. Despite the recent growing interest in this type of technology, “single-use” is not a new phenomenon. First emerging in the early 1980s, biopharmaceutical manufactures utilised it in their production processes as the industry started to produce drugs in larger quantities. However, it is the advances in single-use systems that have resulted in its increasing popularity today.
Single-use technology is dominating the biopharma market, and is thought to currently be used in over 85% of preclinical and clinical manufacturing processes. With no signs of slowing down, the market is predicted to grow at an annual growth rate of 17.5% between 2020 and 2025, according to research from Market Data Forecast. Even with the success of single-use though, stainless steel workflows are unlikely to disappear, and so manufacturers must seek innovative ways to ensure their setup is as efficient and versatile as possible. That’s where precision dispensing technologies hold promise. These precise, flexible, disposable solutions do not require a complete overhaul of a facility and can achieve a wide range of efficiencies as part of different manufacturing setups and processes. Especially suited to applications like raw material handling, they can also minimise the amount that a product must be manipulated within a workflow to safeguard its integrity.
6 ways precision dispensing technology can benefit you
Easily integrated into new or existing workflows, precision dispensing solutions bring fresh opportunities for manufacturers that are still reliant on stainless steel, single-use, or hybrid systems and can have a real impact on process efficiencies and your bottom line.
Reduced handling time
Products can be introduced at all steps of manufacturing, from the earliest stages at which ingredients are weighed and measured to their storage and transfer between different parts of a facility. Drug products must be handled, stored and manufactured using validated processes and equipment to protect the integrity of the final product, and assure the health and satisfaction of the end consumer. This can be extremely time and labor-intensive, requiring additional procedures to be put in place, and increasing the margin for risk or contamination. With precision dispensing technologies, raw materials are pre-weighed and packaged according to manufacturing requirements, eliminating the process of having to manually weigh out different quantities of product from large drums – reducing handling time and thus increasing efficiency for manufacturers.
Lower contamination risk
By reducing the need to handle or manipulate raw materials, precision dispensing technology removes any inadvertent errors that can occur when manually weighing materials. Not only this, but manufacturers can also benefit from the minimised risk of external product contamination from handlers, equipment, and the surrounding environment – a crucial requirement to guarantee the safety of the final drug formulation. This is achieved via a clean connection and dust-free transfer of the product from the containment packaging to the bioreactor. In addition, precision dispense packaging that complies with extractables and leachables regulation for single-use technologies, can also minimise the introduction of contaminants via the packaging itself.
Customisability
Precision dispensing technology offers numerous benefits to manufacturers through its closed architecture and customisability. Single-use packaging, for instance, can be tailored to suit specific fill and weight requirements, so products can be matched to the desired chemistries and processes. Containers are typically available for a wide range of fill types and weights, while outlet port sizes can be changed to suit equipment design. Such attributes allow for a fully customised solution, and offer complete assurance of a controlled delivery, allowing processors to seamlessly discharge the right amount of raw material into the bioreactor for a given formulation.
Increased productivity
To avoid contaminating extremely valuable batches of product, manufacturers must implement extensive cleaning and sterilisation-in-place (CIP, SIP) workflows. This can be challenging as CIP and SIP workflows require time, monetary investment, energy and space, and force manufacturing downtime. Equipment must be completely shut down while it is cleaned, sterilised and validated – all of which can result in up to two weeks of downtime between batches, creating a significant bottleneck in pharmaceutical production. Precision dispensing technologies help to overcome these issues by reducing the time spent handling materials, sampling, dispensing and processing, as well as reducing the significant downtime that comes with cleaning and validating product containers. This means manufacturers are able to process more batches per year, resulting in increased productivity.
Ease of integration
Thanks to its range of customisable “plug and play” options available to suit numerous applications, precision dispensing technology can be quickly and easily integrated into existing manufacturing processes. This offers new opportunities for manufacturers reliant on either stainless steel or single-use equipment and ensures the flexibility needed to keep up with industry as well as guarantee they remain cGMP and FDA compliant. Technologies such as this also reduce the amount of training required to operate the systems, reducing the amount of work hours in streamlining workflows, whilst also offering the same benefits regardless of setup specifics and further enhancing process efficiencies.
Greater compliance and control
Manufacturers should look for single-use packaging solutions that are produced in line with the highest standards of production (ICH Q7 GMP) to further reduce contamination and ensure greater compliance. Meanwhile, precision dispensing technology from a vertically integrated supplier with a single point of audit can offer additional advantages in terms of assurance too, by delivering high levels of transparency and compliance, as well as the added benefit of having extensive knowledge of the raw material science and its provenance.
Looking ahead
As the industry moves away from the ‘blockbuster’ mindset, we expect the popularity of single-use systems to continue to rise. The growing focus on personalised medicines and smaller populations increases the complexity of pharmaceutical manufacturing and requires the swift repurposing of existing assets – making it critical to optimise efficiency wherever possible. Throughout the Covid-19 pandemic, the world looked to the biopharma and pharmaceutical industry for a swift response and the progress made this year in terms of vaccine formulation has forever changed the way the industry will continue to develop.