Developing First Disposable Injector for a Biopharmaceutical - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Developing First Disposable Injector for a Biopharmaceutical


ePT--the Electronic Newsletter of Pharmaceutical Technology

Untitled Document

Bethesda, MD (Oct. 24)—Developing "mechanical components in a drug world" was a challenge, according to Robin Hwang, a senior principal scientist at Amgen (Thousand Oaks, CA, www.amgen.com). Hwang led the team that developed "the first commercial disposable auto-injector for a biopharmaceutical": a prefilled, three-step "SureClick" autoinjector for delivering "Enbrel" (etanercept), a treatment for autoimmune diseases. Etanercept is a recombinant fusion of the tumor necrosis factor receptor and the Fc region of human IgG1, introduced in 1998 by Immunex, which Amgen acquired in 2002.


Hwang spoke at the three-day meeting, "The Universe of Pre-Filled Syringes and Injection Devices Forum," produced by the Parenteral Drug Association (PDA, www.pda.org). PDA officials said that the meeting, which had been planned to draw 150 to 200, had more than 450 registered attendees.


When Enbrel was first introduced, Hwang noted, it was distributed in a vial accompanied by instructions for a 50-step procedure for preparing and injecting the product. Five years later, Amgen introduced a simplified vial-adaptor.


Moving to a self-contained autoinjector, Hwang said, would further simplify administration, lessen patient dependence on providers, and greatly reduce opportunities for dosing errors. It would also increase patient acceptance, compliance, and satisfaction—a key consideration because competing products have emerged onto the market.


Though Hwang noted that the autoinjectors are treated as drug products and not devices, he described the development of "mechanical components in a drug world" as "complex." Pharmaceutical manufacturing engineers had to remaster the art of qualifying and assembling mechanical parts (supplied unassembled by an off-shore partner) and complying with regulations for drug current good manufacturing practice (CGMPs)…while also adhering to the spirit of the quality system regulations that govern medical device manufacturing.


One critical requirement, Hwang said, was to do detailed evaluations of all mechanical components operating in the presence of the drug product, "not to look just at dry-to-dry" performance. The development team had to pay particular attention to what Hwang called interfaces, the points of contact between part-and-part and part-and-drug.


Major points of study, Hwang said, included injection-molding defects; component misalignment; incomplete assembly; detection errors and false rejects in automated inspection; changes in component dimensions during development; and provisions for the reporting and handling of patient and provider inquiries, complaints, and adverse-event reports.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
11%
More stakeholder involvement
11%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here