Download our free resources to learn more about cell therapy, commercialization, manufacturing, and how Minaris Regenerative Medicine can advance your therapy. We expect to continue to add more valuable content here in the near future.
Large-Scale Cell Therapy Manufacturing Using 3D Bioreactors - A Cost-Effective Approach
To make cell therapies widely available, efficient manufacturing process for large quantities of living human stem cells are needed. At Minaris, our team of experts have developed efficient large-scale cell product processes utilizing 3D bioreactors to expand adherent and non-adherent cells.
Minaris' global team of experts have become a trusted partner for clinical and commercial manufacturing of cell therapies. Download our feature that is seen within Nature Biopharma Dealmakers September 2021 issue to read more about our manufacturing, consulting, and development services, and how we are delivering cell-based therapies to patients globally.
The Commercial Manufacturing Checklist for Cell Therapy Developers
To determine whether your patient-specific cell therapy product is ready for commercially viable manufacturing, our team has put together a checklist of items meant to provide you with a rough idea of where your process stands and your commercial readiness.
A Place for NK Cells in the Journey Towards the Next Generation of Adoptive Immunotherapies
In this brief overview, our experts discuss several ways in which Natural Killer (NK) cells can offer us a path forward as a deliver platform for engineered cell (and ex vivo gene) therapy. Here, we focus on four different aspects of cytotoxic cell therapy and provide some contrasts where we feel NK cells can offer promise: Durability, Control, Manufacturing, and Toxicity.
Impact of Apheresis Collection Quality on Manufacturing of Cell Therapeutics
With cell therapy pipelines growing rapidly each year, the need for optimized apheresis collections, a critical first step in the manufacture of many cell therapy products, is evident. Highly variable or poor quality starting apheresis collections present a significant engineering and manufacturing development challenge.
The Cold Truth: Cryopreservation of Final Product in Cell Therapy Manufacturing
While using “fresh” final products in cell therapy manufacturing is perfectly acceptable for proof of concept of the cell therapy, as development into late-stage and then commercial production becomes the goal, different constraints arise. This is where cryopreservation of the final product becomes an option and, in some cases, even a necessity.
Minaris Regenerative Medicine is a global contract and manufacturing organization (CDMO) for cell and gene therapies. We offer our clients high value clinical and commercial manufacturing service, development solutions, and technologies. We are pioneers in the field with more than 20 years' experience providing outstanding quality and reliability.
EU Import and QP Batch Certification of Cell and Gene Therapies
As a full service Contract Development and Manufacturing Organisation (CDMO), Minaris Regenerative Medicine offers EU import services and QP batch certification for cell and gene therapy products manufactured outside the European Union. Our team of experienced Qualified Persons at our manufacturing facilities in Germany is ready to help you to enter the European market.
Early in the COVID-19 Pandemic, our scientists and engineers were asked about whether SARS-CoV-2, the virus that causes COVID-19, posed risk to patients through the manufactured cell therapies they receive. The journal Regenerative Medicine has published a paper written in collaboration between our Germany process development team and our colleagues at Minaris USA - "A risk assessment study of SARS-CoV-2 propagation in the manufacturing of cellular products".
Cryopreservation of Final Product in Cell Therapy Manufacturing
Bringing a cell therapy product to the commercial scale is an enormous challenge. Minaris Regenerative Medicine helps to overcome this challenge by creating a comprehensive roadmap that identifies all of the short, medium, and long term needs of a cell therapy...
Efficient Scale-Up Of Genetically Modified MSCs in Multiplate Bioreactors
Explore the crucial process of scaling up cell therapy development from small-scale to patient treatment. Learn about selecting the right culture system and meeting essential clean room and GMP standards. This white paper offers expert guidance on efficiently achieving large-scale 2D adherent cell cultures.
ddPCR-Based Analytics - Applications and Key Parameters in Developing ddPCR-Based Analytical Methods for Cell and Gene Therapies
Digital PCR (dPCR) is crucial for cell and gene therapy development and quality control. It quantifies viral vectors, monitors gene-edited cells, and measures transgene expression levels. Delve deeper into its applications...
How to Choose The Right Manufacturing Partner to Meet Your Goals
When developing cell or gene therapies, choosing trustworthy partners for manufacturing is crucial. Start the selection process internally, defining project scope, goals, and essential CDMO requirements. This early groundwork enhances the ability to evaluate prospective partners effectively.