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To accelerate time to market and gain a competitive advantage, pharmaceutical development companies are increasingly implementing single-use technologies (SUT).
Single-use technologies are built using a range of components including sample bottles, tubes, filters, clamps, check valves, sterile connectors, locks and luer fittings, seals and nozzles / dispensing nozzles. The technology can be as simple as a single assembly or a complete system made up of several complex assemblies that are used throughout the manufacturing process, including formulation, upstream / downstream processing and filling of the final product. SUTs offer many advantages over traditional stainless steel systems such as the elimination of cleaning-in-place or steam-in-place (CIP / SIP) requirements, faster changes between batches resulting in reduced production time , a more flexible infrastructure and a risk of cross-contamination.
Although both standard and out-of-the-box SUT assemblies are currently available, most are tightly focused on upstream processes using kit components such as bottles, tubes, connectors, and filters that can support them. research applications. There are, however, a few companies at the forefront of single-use filling / finishing systems innovation. Additionally, new biological and synthetic compounds often have unique manufacturing processes that require more advanced custom assemblies than standard off-the-shelf options.
With the increasing adoption of single-use technology for small and large molecule drug development, one of the priority areas for accelerating time to market is the outsourcing of design, development, production and validation of SUT assemblies and systems.
Invest from the start and focus on science
By outsourcing, companies can keep scientists and engineers focused only on developing new products. As product development progresses, scientists shouldn’t be spending their time designing and assembling bottles, caps, and tube systems, but instead focusing on the product. Unfortunately, commercial components may not meet this requirement; Single-use systems comprising various components can quickly become a complex system that requires expertise in material selection, biocompatibility, strength, and connection integrity.
“Research into the development of single-use systems can be a major distraction from the product development process. With a skilled vendor who can integrate manufacturing solutions tailored to each phase, companies can focus on science and new product development, â€said Meghan Elizabeth, Head of Manufacturing Operations at Intelligence – a manufacturer of single-use process components and assemblies, cell transfer vials and collectors for the pharmaceutical, life sciences and specialty chemicals industries.
Develop the SUT in parallel with the drug product
As a product moves from R&D to clinical trials to commercial manufacture, the requirements become more stringent and the development of the SUT must occur in parallel. This type of approach focuses on specific requirements for each phase rather than a single approach.
“Implementing the SUT phase appropriately in the manufacturing process can be integral to accelerating the speed to market,†said Elizabeth. “When small batches of product are made on the bench, the emphasis is on consistency and repeatability to increase the chances of successful scaling. “
As a product moves from benchmarking to clinical trials, the next phase of SUT development is to conduct validation studies and provide documentation that can support the application of the New Investigational Drug (IND) of the SUT. customer and the Good Manufacturing Practices (GMP) required by the United States FDA. GMPs ensure proper design, monitoring and control of manufacturing processes and facilities. This includes setting up quality management systems, obtaining raw materials of the appropriate quality, detecting product quality deviations and working with third party and accredited testing laboratories for feasibility studies and validation of methods.
“Instead of investing the time required to design and manage validation studies, a company can partner with an SUT vendor who can help find risk-based solutions and manage the project directly with the lab.” Elizabeth said. She added that since SUT assemblies are typically custom designs with unique components, the validation process is considerably more complex than in the past.
Due to this complexity, many developers and manufacturers of pharmaceuticals and specialty chemicals find their unique needs best met by outsourcing to a qualified and experienced SUT supplier who can partner with them to provide phase-tailored solutions. along with the validation and documentation needed to navigate each phase of product development, from R&D to commercial manufacturing.
Partner with an experienced SUT design firm
To ease the transition from R&D to commercial manufacturing and accelerate time to market, an experienced SUT supplier has:
- an established supply chain of research and GMP compliant components;
- a proven and waterproof connection design library;
- validated manufacturing, assembly, testing and packaging processes and a registered quality management system.
If a component is not commercially available, the supplier can design and print 3D parts to meet customer’s quality and regulatory requirements such as biocompatibility and non-animal origin. An experienced SUT supplier works with a client’s technical team to design and develop SUT solutions tailored to each phase based on the specific application and development phase.
“A knowledgeable supplier adapts the design and development of the SUT to align and evolve with the customer’s product development based on the appropriate phase requirements, manufacturing strategy and risk assessment,†Elizabeth explained. .
As a qualified supplier to major pharmaceutical manufacturers, Elizabeth said that Intellitech works with customers to validate processes and define acceptable operating ranges, critical quality attributes and intended system acceptance criteria. The company also partners with accredited laboratories to test joint strength, integrity, bioburden, sterility and shelf life, and further creates, approves, publishes and maintains the documentation required to meet requirements. of GMP.
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