Final assembly, labeling and packaging: How SHL is addressing client demand for a frustration-free last mile
For a pharma or biotech company working with a drug delivery device partner, the decision on final assembly, labeling and packaging is most often the final checkpoint in the development process for a combination product. Well in advance of this checkpoint, the pharma/biotech company must make an informed decision regarding the device’s final assembly: establish assembly and packaging infrastructure internally, or partner with a contract manufacturing organization (CMO).
SHL Group details its approach to the challenges of emerging formulations
Building internal infrastructure is a decision that would likely involve input from a large cross-functional team across the organization, with considerations such as the following:
- What is the overall cost of such internal infrastructure (e.g., capital expense, staffing requirements)?
- How does building this internal infrastructure align with the long-term commercial strategy of the company and the product?
- How long will this high quality and regulatory compliant infrastructure take to implement?
- What is the risk mitigation strategy if things do not go as planned?
- Are semi-automated equipment and processes acceptable or are more complex automated solutions required based on the forecasted demand?
The company’s infrastructure for final assembly should be future-proof: scalable to accommodate multiple products as well as changes to device volume over time, in the best and the worst case scenarios.
Lastly, it is important to consider whether the infrastructure can be leveraged across multiple products, keeping in mind that many devices differ in shape, size, and industrial design. The company’s infrastructure for final assembly should be future-proof: scalable to accommodate multiple products as well as changes to device volume over time, in the best and the worst case scenarios.
After years of working with clients and understanding their needs, SHL Group has developed a simple solution that eliminates the frustrations commonly encountered in the final mile of the development process. SHL, a leader in device design and manufacturing, has heavily invested in recent years to establish a contract manufacturing service offering final assembly, labeling and packaging for SHL-designed devices. With the addition of this business unit, SHL is able to provide a full turnkey solution from device development through to the commercial launch of a finished product, decreasing timelines to the clinic and/or commercial market for patients in need. Using our mature device platforms and infrastructure, SHL’s quick-to-clinic or quick-to-market development process can take a partner from device development to clinic/commercial supply in under 15 months.
SHL’s contract manufacturing facility for final assembly, labeling and packaging is based in Deerfield Beach, Florida. This 45,000-square-foot, regulatory approved facility houses specialized equipment and processes to support both low and high volume product requirements. Most of its device assembly and test equipment was designed and built by SHL’s in-house automation team, resulting in total integration between the device and equipment developers. Additionally, SHL has invested in universal equipment designed to be flexible, providing a wide range of capabilities that include final assembly, bulk packing, labeling, packaging/kitting, and serialization.
The required specialist skills are immediately available on-site to manage, drive and complete the project in scope. SHL’s engineers are hand-picked from the pharma, biotech and medical device industries, offering a unique understanding to the needs of our clients. Located near multiple international airports, our world-class facility has an optimized materials flow starting from the receipt of inbound goods to storage in refrigerated/ambient warehouses; assembly, labeling and packaging; and shipping of finished product to our partners or a preferred distribution center.
SHL is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery devices such as auto injectors and pen injectors. With locations in Taiwan, Sweden and the US, our experienced engineers and designers develop product enhancements and breakthrough drug delivery solutions for pharma and biotech clients globally. Significant investment in R&D has enhanced our broad pipeline of next-generation drug delivery systems. These innovative devices include a range of disposable and reusable injectors with fixed or variable dosing and the ability to accommodate high viscosities.
With over 3,700 staff worldwide, our organization consists of several distinct group companies:
SHL Medical designs, develops and manufactures advanced drug delivery devices, as well as provides final assembly, labeling and packaging services for leading pharmaceutical and biotech companies across the globe.
SHL Healthcare develops and manufactures equipment solutions for home, hospital and long term care use.
SHL Technologies provides contract manufacturing and engineering services for the production of complex medtech and industrial products.
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