1 / 6

Comprehensive Process Development Solutions for Advanced Therapies

We offer comprehensive process development solutions for advanced therapies, including cell and gene therapies. Our services cover process design, optimization, scale-up, and regulatory supportu2014ensuring scalable, GMP-compliant manufacturing that accelerates your therapy from research to clinical and commercial success.

Xellera
Download Presentation

Comprehensive Process Development Solutions for Advanced Therapies

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Comprehensive Process Development Solutions for Advanced Therapies www.xelleratherapeutics.com

  2. Introduction At the forefront of regenerative medicine, our Process Development Services provide a critical bridge between scientific discovery and clinical/commercial manufacturing. We specialize in designing, optimizing, and scaling robust, compliant, and phase-appropriate processes for cell therapies, gene therapies, and other Advanced Therapy Medicinal Products (ATMPs).

  3. Our Process Development Capabilities Process Design & Optimization Scale-Up & Technology Transfer Analytical Method Development Formulation and Fill-Finish Support

  4. Regulatory & Quality Integration Phase-appropriate development aligned with FDA, EMA, and PMDA expectations Early engagement with QA for regulatory risk mitigation Documentation ready for IND, IMPD, and BLA submissions Support for comparability studies, batch records, and validation planning

  5. Why Partner With Us? Deep Expertise in ATMP development End-to-End Services from research to GMP manufacturing Scalable & Reproducible processes ready for regulatory success Client-Centric Approach with flexible, collaborative project models Accelerated Timelines to clinic and market

  6. Contact us Unit1801, 09-16, 18/F, Millennium City 5, 418 Kwun Tong Road, Kwun Tong, Kowloon, Hong Kong +852 2618 3356 inquiry@xelleratherapeutics.com www.xelleratherapeutics.com

More Related