Modern cell and gene therapeutics can be used to treat previously incurable diseases. However, manufacturing them is regarded as costly and time-consuming. No wonder, considering that individual patient material is often used, which is then processed for days or weeks. To succeed, you need custom-fit automated and modularly extendable isolator-based machine platforms.
This is our field of expertise: Complete production and filling solutions for the pharmaceutical and biotech industries – efficient, economical, and future-proof. We develop these together with you to ensure they can often replace complex work steps and manual handling.
As a technology partner, we support you along the entire process chain – from clinical development to commercial production and the filling of different batch sizes. Will you change the medicine of tomorrow with us?
Highly sensitive drugs, such as those used in cell and gene therapies, require highly flexible machine solutions with high processing reliability.
Whether viral vectors, (gene-modified) cell therapy, suspension cells such as CAR-T lymphocytes or adherent cells: Adept at handling sensitive products, we find the best possible solution for producing and filling containers such as bags, bottles or vials as well as for working in different cell culture vessels.
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Manufacturing cell and gene therapeutics involves multiple process steps that often take days and weeks to complete. You determine the degree of automation: The ProCell production platform allows everything from manual work in the isolator to fully automated expansion stages.
Your benefits:
Manufacturing cell and gene therapeutics involves multiple process steps that often take days and weeks to complete. You determine the degree of automation: The ProCell production platform allows everything from manual work in the isolator to fully automated expansion stages.
Your benefits:
With the help of the ProCell, the amount of work, in other words, the number of hours that qualified personnel currently spend on manufacturing CAR-T cells, can be reduced by at least 50 percent. In cooperation with our customers, we are developing the often laborious manual production of patient-specific therapeutics to the point of full automation.
The many production steps include upstream and downstream processes. Upstream processes include cell selection, genetic modification, and cell proliferation, among others. Downstream processes include purification and the final formulation of cell and gene therapeutics.
With a production platform like ProCell, you always have an overview of all process steps. Thanks to isolator technology, the operator and product remain safely separated from each other. Intelligent software accompanies the process and enables its automation.
Optima Pharma's ProCell production isolators are modular in design. In concrete terms, this means you can create open and closed production areas, define the process sequence individually, integrate different devices and process steps, or use the option to scale out.
OPTIMA pharma GmbH and its partners, Robert-Bosch-Hospital (RBK) in Stuttgart and Heidelberg University-Hospital (UKHD) are working on the first decentralized automated production facility for cell and gene therapeutics.
The “ProCell for Patient” project for the automated production of CAR-T cell therapies is required by the state of Baden-Württemberg.
The forum for health and wellness in Baden-Württemberg supports the “ProCell for Patient” project.
You want to fill your sensitive gene and cell therapeutics flexibly, fully controlled, and with zero product loss. For Fill & Finish, Optima Pharma offers FillCell, a wide range of filling systems for all therapeutic applications and container types. We adapt the machine concept to your product.
Integrated product saving features prevent product loss. For you, this means maximum yield and cost efficiency. Robot technology makes FillCell filling lines highly flexible, and systems for rapid decontamination ensure economical and safe processes.
Your benefits:
You want to fill your sensitive gene and cell therapeutics flexibly, fully controlled, and with zero product loss. For Fill & Finish, Optima Pharma offers FillCell, a wide range of filling systems for all therapeutic applications and container types. We adapt the machine concept to your product.
Integrated product saving features prevent product loss. For you, this means maximum yield and cost efficiency. Robot technology makes FillCell filling lines highly flexible, and systems for rapid decontamination ensure economical and safe processes.
Your benefits:
What should your FillCell filling solution for cell and gene therapeutics look like? That depends on your product. We define the best feeding process depending on the container required. Maximum product yield and cost efficiency during filling and closing are ensured by sophisticated functions for redosing, restoppering, and recapping, as well as 100% process control.
The compact, BSL-2 compatible isolator with DECOpulse decontamination system promises maximum safety for both products and operating personnel. Your advantage: short cycle times combined with reliable decontamination (this is ensured by uniform moistening of the inner surfaces with vaporized H2O2). Distinguished with the Biotech Award.
In-process controls guarantee both product and process safety as well as maximum product yield and the resulting cost efficiency. For example, you can activate a one hundred percent weight control plus redosing function during the filling process. In combination, both functions ensure that the intended filling quantity is reached.