Outsourcing single-use technologies to speed time to market – PharmaLive
Development of new products: Outsourcing Single-Use Technologies to Accelerate Time-to-Market
To accelerate time to market and gain a competitive advantage, pharmaceutical development companies are increasingly implementing single-use technologies (SUTs). Single-use technologies are constructed using a range of components including sample bottles, tubing, filters, clamps, check valves, sterile connectors, Luer locks and fittings, seals and dispensing tips/nozzles. The technology can be as simple as a single assembly or a complete system consisting of several complex assemblies that are used throughout the manufacturing process, including formulation, upstream/downstream processing and filling of the final product.
The SUT offers many advantages over traditional stainless steel systems, such as the elimination of clean-in-place or steam-in-place (CIP/SIP) requirements, faster changeovers between batches, reducing time of production, a more flexible infrastructure and a reduced risk of cross-contamination.
Although off-the-shelf standard SUT assemblies are currently available, most are narrowly focused on upstream processes using kit components such as bottles, tubing, connectors, and filters that may support research applications. . However, a few companies are at the forefront of innovating single-use systems for filling/finishing. Additionally, new biologics and synthetic compounds often have unique manufacturing processes that require more advanced custom assemblies than standard off-the-shelf options.
Given the increasing adoption of single-use technology for the development of small and large molecule drugs, one of the priority areas for accelerating time to market is outsourcing the design, development, production and validation of assemblies and SUT systems.
Invest upfront and focus on science
By outsourcing, companies can keep scientists and engineers focused solely on developing new products. As product development progresses, scientists should not spend their time designing and assembling bottles, caps and tubing systems, but rather focus on the product. Unfortunately, off-the-shelf components may not meet the requirement.
Single-use systems composed of various components can quickly become a complex system that requires expertise in material selection, biocompatibility, strength and connection integrity.
“Research on the development of single-use systems can be a major distraction for the product development process. With a qualified supplier able to integrate phase-appropriate manufacturing solutions, companies can focus on science and new product development,” says Meghan Elizabeth, Manufacturing Operations Manager at Intellitech, Inc., an innovative manufacturer of single-use process components and assemblies, cell transfer flasks and manifolds for the pharmaceutical, life science and specialty chemical industries.
Developing the SUT in parallel with the drug product
As a product moves from R&D to clinical trials and then to commercial manufacturing, the requirements become more stringent and the development of the SUT should grow concurrently. This type of approach focuses on specific requirements at each phase rather than a single approach.
“Properly implementing the SUT phase in the manufacturing process can be integral to accelerating the speed to market.” says Elizabeth. “When small batches of products are made on the bench, the focus is on consistency and repeatability to increase the likelihood of successful scale-up.”
As a product progresses from the bench to clinical trials, the next phase of SUT development is to conduct validation studies and provide documentation that can support the investigational new drug (IND) application of the customer and Good Manufacturing Practices (GMP) required by the FDA. GMPs ensure proper design, monitoring and control of manufacturing processes and facilities. This includes implementing quality management systems, obtaining appropriate quality raw materials, detecting product quality deviations, and working with accredited third-party testing laboratories for feasibility and method validation.
“Instead of investing the time needed to design and manage validation studies, a company can partner with an SUT provider who can help find risk-based solutions and manage the project directly with the lab. “says Elizabeth, adding that because 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 pharmaceutical and specialty chemical developers and manufacturers find their unique requirements best served by outsourcing to a qualified and experienced SUT supplier who can partner with them to provide solutions tailored to the phase as well as 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 vendor has:
- An established supply chain of research and GMP-compliant components
- A proven and watertight connection design library
- Validated manufacturing, assembly, testing and packaging processes and registered quality management system
Additionally, if a component is not commercially available, the supplier can design and 3D print parts that meet the customer’s quality and regulatory requirements such as biocompatibility and non-animal origin.
An experienced SUT vendor works with a customer’s technical team to design and develop phase-appropriate SUT solutions based on the specific application and development phase.
“A competent supplier tailors the design and development of the SUT to align and grow with the customer’s product development based on phase-appropriate requirements, manufacturing strategy, and risk assessment.” explains Elizabeth.
BPI Labs, LLC, a subsidiary of Belcher Pharmaceuticals, is a current Intellitech customer focused on the development and manufacturing of injectable drugs. According to Brian Neuman, principal engineer at BPI Labs, the company has about 50 injectables in various phases, from early R&D to commercial manufacturing and packaging. With so many products in development, single-use technology is uniquely suited to how they work.
“Some companies just make a product non-stop and never have to make a change,” Neuman says. “But that’s not our company’s goal. We’re always trying to expand what we produce here, and that just means we’ll have different requirements along the way.
Given their unique and ever-changing requirements, BPI Labs decided to outsource non-proprietary SUT assemblies and systems to an experienced company that could provide more flexibility. Neuman says he was impressed with Intellitech’s willingness to consult and provide expertise throughout the process.
“We were able to have meetings with them to discuss any specific requirements we have for our facility and our process,” says Neuman. “When we’ve done that, the general response has been ‘Yes, we can do that’, as opposed to ‘It’s not in our standard offering.'”
As a qualified supplier to major pharmaceutical manufacturers, Elizabeth says 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 seals for strength, integrity, bioburden, sterility and shelf life.
The company also creates, approves, publishes and maintains the documentation required to meet GMP requirements. This includes drawings, bill of materials, work instructions, data collection forms, batch records and certificate of compliance.
For more information, call 866.434.5548; Fax 410.876.1256; E-mail [email protected]; Visit intellitech-inc.com.
For more information on public relations, contact:
Carlo Chatman, Power PR
Telephone (310) 787-1940
Fax (310) 787-1970
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