Aseptic Fill-Finish Services

With over 20 years of fill/finish expertise and state-of-the-art facilities, Mycenax consistently delivers high-quality drug products for diverse modalities.
Our cGMP-certified facilities feature two drug product (DP) production lines equipped with isolators and restricted-access barrier systems, all within a Grade A area. We offer flexible manufacturing solutions for clinical trials and market needs, specializing in liquid and lyophilized formulations as well as various delivery systems, ensuring high-quality drug products throughout their lifecycle.

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Complete DS to DP solution

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Completed filling of 500,000 units over the past 3 years

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Flexible vial and batch sizes: 2R, 4R, 10R from 1,000 to 100,000 units

From Formulation to Aseptic Filling

Mycenax’s aseptic filling services cover the entire process—from formulation and DP process development to characterization and validation. Our services include sterile filling, analytical services, and regulatory compliance, all designed to ensure the highest standards of quality and consistency.

Flexible Scale, Flexible Dosage

Our aseptic filling capacities include vials, pre-filled syringes, and cartridges, offering scalable solutions from clinical to commercial production.

Experience the Automated Aseptic Filling Line from OPTIMA

Our fill-finish line integrates OPTIMA’s globally renowned automated systems and sterile isolation devices, including filling machines, freeze dryers, and isolators. Its flexible design accommodates various types and sizes, enabling quick changeovers that enhance production flexibility and optimize product quality.

With over 20 years of fill/finish expertise and state-of-the-art facilities, Mycenax consistently delivers high-quality drug products for diverse modalities.

Our cGMP-certified facilities feature two drug product (DP) production lines equipped with isolators and restricted-access barrier systems, all within a Grade A area. We offer flexible manufacturing solutions for clinical trials and market needs, specializing in liquid and lyophilized formulations as well as various delivery systems, ensuring high-quality drug products throughout their lifecycle.

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