Synbias Pharma/GeminiPharmChem

Drug Product Development

Synbias-Gemini Group

Comprehensive CDMO Services for Pharmaceutical Innovation

At Synbias-Gemini Group, we offer comprehensive Contract Development and Manufacturing Organization (CDMO) services tailored to meet the needs of pharmaceutical innovators.

Our expertise in chemical development, combined with our state-of-the-art facilities, allows us to deliver exceptional quality in every phase of the drug development lifecycle.

Chemical Development in Highly Potent Laboratory Environment:

Our highly potent laboratory environment is equipped to handle the development of complex Active Pharmaceutical Ingredients. We focus on:

Process Development and Optimization: We develop and refine chemical processes to ensure efficiency, safety, and high yield for API production.
Identification of Key Process Parameters: Critical parameters are identified and controlled to ensure the consistency and quality of the API throughout production.
Scale-up to 50-100g: Our lab-to-pilot scale capabilities allow for the smooth transition from research to manufacturing, with API scale-up ranging from 50 to 100 grams.
Analytical Method Development: We develop precise analytical methods to ensure the purity and stability of our APIs.

Quality by Design (QbD) Strategy: Our QbD approach ensures that quality is built into the product from the start, leading to better reliability and compliance with regulatory standards.
GLP, GMP Documentation: We provide full documentation in accordance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards, ensuring regulatory compliance and ease of product approval.
Forced Stability and ICH Stability Studies: Comprehensive stability studies are conducted to assess the shelf-life and stability of APIs under various conditions, following International Council for Harmonisation (ICH) guidelines.

Possible Further Commercial Manufacturing:

In addition to early-stage development, Synbias-Gemini Group offers services for the commercial manufacturing of APIs:

Validation of Manufacturing Process: We provide thorough validation of the manufacturing processes to ensure compliance with regulatory standards and consistency in commercial production.
Preparation and Filing of Drug Master File (DMF): Our team prepares and files DMFs to support regulatory submissions and streamline the approval process for APIs.

Industrial Manufacturing: Our commercial-scale manufacturing capabilities ensure the efficient production of high-quality APIs, supported by our flexible and multipurpose production lines.
Life-cycle Management: We offer ongoing support for product life-cycle management, including post-approval changes, process improvements, and optimization for long-term commercial success.