Manufacturing Services

Regardless of the type of cell therapy product or the medical indication, the production of cell-based therapeutics is highly complex. Minaris Regenerative Medicine offers you a comprehensive manufacturing experience that is fully compliant with the relevant regional regulatory requirements of our global facilities in North America, Europe, and Asia.

The GMP Manufacturing Process

Learn more below about how our experts offer you a comprehensive manufacturing experience, fully compliant with the relevant regional regulatory requirements of our global facilities in North America, Europe, and Asia.

Technology Transfer

The start to an exciting manufacturing process. We have successfully executed more than 70 tech transfers for cell therapy products and have a systematic and strategic approach to ensure high quality.

Clinical Manufacturing

We create a customized, fully compliant clinical manufacturing program in accordance with FDA and EMA guidelines. By listening to your specific needs and challenges, our team will advance your product to commercial readiness.

Commercial Manufacturing

Our experience with commercial manufacturing allows us to be your trusted partner to supply your therapeutic worldwide. We support you in any way to reach your goal of market authorization.

Click here to contact our team about your manufacturing needs

Commercial Manufacturing

Whether you are looking ahead in anticipation of potential commercial production, should your product achieve the prerequisite regulatory approvals, or you have received such approval, Minaris Regenerative Medicine has commercial manufacturing capabilities and experience to serve your needs.

Established state-of-the-art facilities in all regions with the systems and infrastructure needed to allow for commercial manufacturing.
Ability for late-stage products to seamlessly transition into commercial production at our facilities.
For clinical applications and commercial use in Europe, we offer release by a Qualified Person (QP) for products manufactured in the EU, as well as for products manufactured at our sites in the US or Japan for the European market.

Clinical Manufacturing

We have served the clinical manufacturing programs of more than 180 clients with cGMP Manufacturing (FDA guidelines) and GMP Manufacturing (EMA guidelines). Our team:

Listens to your needs
Learns your specific challenges and goals
Customizes a clinical manufacturing program for you to create a long-standing and trusting contract manufacturing partnership

We help you advance through the phases of clinical development and optimize your manufacturing process toward commercial viability. Our GMP manufacturing capabilities include:

Automating cell therapy manufacturing processes, including the Fill and Finish of the product. This allows us to create closed systems that enhance the efficiency and reliability of production and improve GMP compliance for the product.
Extensive experience with GMP manufacturing for Phase III trials. This helps clients advance towards reaching commercial manufacturing readiness, identifying issues that impact the quality, scalability, sustainability, and cost of goods for their cell therapy product and providing advice to overcome them.

Technology Transfer

A technology transfer for cell therapy manufacturing is the transmission of knowledge, experience, specifications, procedures, and other critical data to another organization/facility, such as a contract development and manufacturing organization (CDMO), with the goal of establishing GMP-compliant manufacturing as needed for the respective clinical stage and regulatory environment (FDA, EMA, or PMDA).

Minaris Regenerative Medicine has performed more than 70 successful tech transfers for cell therapy products in different clinical trial phases through our systematic and strategic approach.

We do not claim ownership of the cell therapy product, or any of the IP needed to manufacture it.

Manufacturing Services

The GMP Manufacturing Process

Technology Transfer

Clinical Manufacturing

Commercial Manufacturing

Click here to contact our team about your manufacturing needs

Commercial Manufacturing

Clinical Manufacturing

Technology Transfer

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