Product Launch for Biologics Manufacturer

QSN assisted biologics manufacturer with successful launch of a platform medical device to be used with various biologics agents (otherwise known by FDA as a combination product under FDA 21CRFR Part 3).

Company Profile

  • Established in the late 70’s.
  • Premier provider of healthcare treatments to clinicians and patients worldwide.
  • Therapeutic areas include: Immunology, oncology, and nephrology.
  • Lengthy pipeline of products, but had not launched any recent biologic products.

Business Situation

The biologics manufacturer wanted to increase market share in the immunology sector by launching a platform medical device to be used with various biologics agents (otherwise known by FDA as a combination product under FDA 21CRFR Part 3). The biologics manufacturer had a centralized project management function that managed supply chain initiatives, but needed to ramp up their resources to support the new launch.

Technical Situation

The project management function was a well-developed organization equipped to handle complex biologics product launches. The biologics manufacturer was very effective in managing multiple sub-projects, integrated into one master project, using Microsoft Project to track cross-functional domestic, and international activities. The biologics manufacturer had the expertise for development of the biologic, but now wanted to bring in external medical device knowledge (FDA 21 CFR Part 820) related to the manufacture of a prefilled safety syringe and needle assembly.


QSN was contracted to provide several resources to the biologics manufacturer with not only biologics background, but also medical device background. QSN consultants joined the company’s team and started out by building Microsoft Project schedules for the design and development of the medical device, and the production and filling of the medical device at an internationally located contract manufacturer. During prototyping through commercialization, QSN supported all mold qualifications for the molded parts by coordinating measuring with a contract test and measurement lab. Metrology support was provided to include gage R&Rs, statistical analyses of data, and Design of Experiments (DOE). QSN also participated in the build of the design history file under design controls, and facilitated many of the design verification activities by developing protocols, coordinating testing, and preparing verification reports. QSN maintained the project schedules, working with various project leaders and team members to ensure tasks were executed according to very tight timelines through launch of the project.


QSN participated in the successful launch of the client’s product. QSN had developed project schedule templates that teams could use for future product launches with medical devices. QSN also developed a traceability matrix template that could be used to map design requirements to verification and validation activities, which was instrumental to the design control process. A successful transfer of knowledge left the client with a more robust design control process. This was evidenced through an internal audit that was conducted by the client with minimal compliance findings.