Outsourcing single-use technologies to accelerate speed to market
To fast-track time to market and gain a competitive edge, pharmaceutical development companies are increasingly implementing single-use technologies (SUT).
Single-use technologies are built using an array of components, including sampling bottles, tubing, filters, clamps, check valves, sterile connectors, Luer locks and fittings, seals and gaskets, and dispensing tips/nozzles. The technology can be as simple as a single assembly or an entire system made up of multiple complex assemblies that are utilised across the entire manufacturing process, including formulation, upstream/downstream processing and final product filling. SUTs offer many benefits compared to traditional stainless steel systems, such as the elimination of clean-in-place or steam-in-place (CIP/SIP) requirements, faster changeovers between batches resulting in reduced production time, more flexible infrastructure and a decreased risk of cross-contamination.
Although standard, off-the-shelf SUT assemblies are currently available, most are narrowly focused on upstream processes using kit components like bottles, tubing, connectors and filters likely supporting research applications. There are, however, a few companies leading the innovation of single-use systems for fill/finish. In addition, novel biologics and synthetic compounds often have unique manufacturing processes that require custom assemblies that are more advanced than standard off-the-shelf options.
Given the increasing adoption of single-use technology for both small- and large-molecule drug development, one area of emphasis to speed time to market is outsourcing the design, development, production and validation of the SUT assemblies and systems.
Invest upfront and focus on the science
By outsourcing, companies can keep the scientists and engineers focused solely on new product development. As product development progresses, scientists should not be spending their time designing and putting together bottles, caps and tubing systems, but instead maintain focus on the product. Unfortunately, off-the-shelf components may not meet this requirement; single-use systems comprising various components can quickly become a complex system that requires expertise in choice of materials, biocompatibility, connection strength and integrity.
“Research into the development of single-use systems can be a major distraction to the product development process. With a qualified supplier that can integrate phase appropriate manufacturing solutions, companies can focus on the science and new product development,” said Meghan Elizabeth, Manufacturing Operations Manager at Intellitech — a manufacturer of single-use process components and assemblies, cell transfer bottles and manifolds for the pharmaceutical, life sciences and specialty chemical industries.
Develop SUT in parallel with drug product
As a product moves out of R&D into clinical trials and then into commercial manufacturing, the requirements become more stringent and the SUT development should build concurrently. This type of approach focuses on specific requirements at each phase rather than a one-size-fits-all approach.
“Phase-appropriate implementation of SUT into the manufacturing process can be integral to accelerating the speed to market,” Elizabeth said. “When small batches of product are being manufactured at the bench, the focus is on consistency and repeatability to increase the likelihood of successful scale-up.”
As a product progresses from the bench into clinical trials, the next phase of SUT development is to conduct validation studies and provide documentation that can support the customer’s Investigational New Drug (IND) Application and Good Manufacturing Practices (GMP) required by the US FDA. GMPs assure proper design, monitoring and control of manufacturing processes and facilities. This includes establishing quality management systems, obtaining appropriate quality raw materials, detecting product quality deviations and collaborating with third-party, accredited testing laboratories for method feasibility and validation studies.
“Instead of investing the time required for the design and management of validation studies, a company can partner with a SUT supplier that can aid in risk-based solutions and manage the project directly with the lab,” Elizabeth said. She added that because SUT assemblies are typically custom designs with unique components, the validation process is considerably more complex than in the past.
As a result of this complexity, many pharmaceutical and specialty chemical developers and manufacturers are finding their unique requirements better served by outsourcing to a qualified and experienced SUT supplier that can partner with them to provide phase-appropriate solutions along with the necessary validation and documentation to navigate each product development phase from R&D through to commercial manufacturing.
Partner with an experienced SUT design firm
To facilitate the transition from R&D to commercial manufacturing and increase speed to market, an experienced SUT supplier has:
- an established supply chain of research and GMP-compliant components;
- a design library of proven, leak-proof connection;
- 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 that are compliant with the customer quality and regulatory requirements such as biocompatibility and non-animal origin. An experienced SUT supplier collaborates with a customer’s technical team to design and develop phase-appropriate SUT solutions based on the specific application and phase of development.
“A knowledgeable supplier tailors the SUT design and development to align and grow with the customer’s product development based on phase-appropriate requirements, manufacturing strategy and risk assessment,” Elizabeth explained.
As a qualified supplier to top pharmaceutical manufacturers, Elizabeth said Intellitech works with customers to validate processes and define acceptable operating ranges, critical quality attributes and acceptance criteria of the intended system. The company also partners with accredited labs for testing seal strength, integrity, bioburden, sterility and shelf life, and additionally creates, approves, releases and maintains the required documentation to support GMP requirements.
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