Pharma Tech Industries and the Development of a Heat-Stable Auto-Injector

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How Pharma Tech Industries’ broad capabilities helped an innovative company get a game-changing product to market quickly, economically, and safely

Project Background: Biotech Innovation in Heat-Stable Epinephrine Auto-Injectors

A biotech company focused on medical devices for severe allergies engaged Pharma Tech Industries to develop an innovative auto-injector technology designed to administer heat-stable epinephrine. This device aims to treat anaphylaxis resulting from acute allergy attacks and features a wet/dry, dual-chamber system that enhances temperature resilience and extends the shelf life of the medication.

Challenges In Developing and Manufacturing: Finding the right Pharma CDMO expertise for a sophisticated solution

Complexity of a Dual-Chamber Auto-Injector Design: The auto-injector’s design includes a dual-chamber system for mixing powders and liquids, a departure from traditional liquid formulations. This complexity presented a challenge in finding a suitable pharmaceutical contract manufacturer with the required expertise.
Cost and Commitment Issues: Many sterile-fill-finish providers were deterred by the unique nature of the product and quoted high prices. Additionally, securing their commitment was difficult due to the project’s innovative and unorthodox approach.
Urgency in Scaling Up: The biotech company required rapid scale-up from lab-scale development to commercial-scale production, which added urgency to the project.

Pharma Tech Industries’ Solution

1. Detailed Proposal and Expertise in Product Development & Manufacturing

Proposal

Pharma Tech Industries responded to the RFP with a thorough 40-page proposal, demonstrating their ability to handle the project’s complexities. This proposal was supported by input from experts in the field, showcasing Pharma Tech Industries’ depth of knowledge and capability.

Expertise

Pharma Tech Industries assembled a dedicated team with extensive experience in the area of auto-injectors and powder-based formulations. This team was crucial in addressing the technical challenges and ensuring smooth project execution.

2. Facility Adaptation and Equipment

Facility Setup

Pharma Tech Industries utilized its 300,000 square feet cGMP pharma facility to set up a new ISO 7 Pharma Suite. The installation of bespoke equipment was completed in less than four months, demonstrating Pharma Tech Industries’ ability to rapidly adapt its infrastructure to meet the specific requirements of the medical device packaging project.

Commercial-Scale Equipment

Pharma Tech Industries swiftly scaled up from lab-scale to commercial-scale production by integrating advanced pharma manufacturing equipment specifically designed for the auto-injector project.

3. Comprehensive Pharma Manufacturing Process

Pharma Tech Industries’ pharma manufacturing process for the auto-injector includes:

Inputting: Preparation and handling of the active pharmaceutical ingredient (API), process consumables, and device components.
Forming and Filling: Formation and filling of the drug product into its primary container closure system.
Outputting: Sealing of the primary drug container for further processing, including downstream sterilization and final device assembly.
Medical Device Packaging: Completion of both primary and secondary packaging processes.

4. Commitment to Product Development Timelines

Speed: Pharma Tech Industries’ ability to work quickly and efficiently was a key factor in their selection. The contract pharmaceutical company was committed to aligning with the biotech company’s tight timelines and ensuring that the project progressed without delays.

Successful Outcomes in the Developing the Heat-Stable Auto-Injector

Technical Batches

Technical batches of the auto-injector were successfully produced in April 2023.

Registration Batches

Production of registration batches is scheduled for 2 2025, in line with the project’s timeline.