Cell and Gene Therapies

Smart Solutions for Pharma Experts

Production and Filling of Cell and Gene Therapies

OPTIMA pharma – Your Partner for Comprehensive System Solutions

Cell and gene therapies can now be used to effectively treat what were previously incurable diseases. Until now, however, it has been costly and time-consuming to produce them. This is where Optima Pharma comes in. We will assist you with efficient, cost-effective production and filling that ensures a completely closed process flow. We achieve this with automated, modular and highly flexible isolator-based machine platforms. High levels of process and product safety ensure that your products are processed and filled with care. We are your technological partner for the entire process chain. The basis for this approach is a close partnership from the very beginning, a comprehensive understanding of the process and digital integration of innovative technologies. We are shaping the future together.

Key Facts

How You benefit from a Partnership with OPTIMA

Maximized product yield due to smart dosing functions

High levels of product and process safety

Highly flexible due to the integration of robot technology

Integrated platform with isolator technology

”Highly sensitive drugs such as those used in cell and gene therapies require highly flexible machine solutions with high levels of processing reliability and a small footprint.”

Dr. Andrea Traube, Director Market Development Pharma, OPTIMA pharma GmbH

Processing Solutions for Cell and Gene Therapies

A One-Stop Shop for Production and Filling Solutions

Production

The manufacturing of cell and gene therapies involves numerous individual process steps. Using production isolators from Optima Pharma ensures all corresponding process steps are performed in a closed environment with a high level of safety. The modular design allows customization of the process flow and integration of external devices. You can decide on the level of automation you need. All variants are possible, from manual isolators with an integrated centrifuge to fully automated configuration stages.

Benefits

Modular design
High levels of process safety
Strict separation of operator and product
Process automation and automated batch logging

Filling

Optima Pharma also offers you a dedicated portfolio of specific machine solutions for the fill & finish of cell and gene therapies. The machine design is primarily geared to meet your product needs. A range of integrated technologies known as "product saving features" ensure high product yield and maximum cost efficiency. Using robot technology maximizes flexibility, while rapid decontamination systems ensure increased efficiency and safety of your filling process.

Benefits

Flexible robotics platform
100 % in-process controls
Integrated technologies to minimize product loss
Turnkey solution with integrated isolator

OPTIMA pharma is your Partner - from Individual to System-Based Solutions

Optima Pharma is your partner for manufacturing and filling technologies for cell and gene therapies, with end-to-end system solutions and a comprehensive knowledge of the process. We accompany you throughout the entire life cycle of your product - from clinical development to commercial production and the filling of a variety of batch sizes. We are already working with you today to find the right tailor-made solution to meet your future requirements.

Production Solutions
for Cell and Gene Therapies

Process Steps in the Production of Cell and Gene Therapies

How We support You

Process steps production of cell and gene therapies

The manufacturing of cell and gene therapies involves numerous individual process steps. As well as the upstream processes like cell selection, genetic modification and cell expansion, there are downstream processes like purification and final formulation.
Your production platform from Optima Pharma allows you to map and reliably execute all the significant process steps. The operators and the product are always kept apart by proven isolator technology. The modular design allows you to customize your processes within the production isolator, gives you the option to successfully scale-out processes, and provides the option of integrating external equipment into your production process.

OPTIMA pharma Production Isolators

Maximum Flexibility in Automating Your Processes

Compact BSL 2-compatible isolator with our Biotech award winning decontamination system
Fully integrated HMI and modular software architecture
Automation and the use of robot technology
Integrated centrifuge for cell processing
Rapid material transfer via H2O2 material lock

Filling Solutions
for Cell and Gene Therapies

Filling Solutions
for Cell and Gene Therpies

Process Steps in the Filling of Cell and Gene Therapies

How We support You

Our filling solutions for cell and gene therapies are primarily geared to meet the needs of your product. We define the infeed process in line with the container your product requires. For the filling and closing process, there are a wide range of integrated technologies to minimize product loss and ensure high product yields and maximum cost efficiency. These include a variety of re-dosing, re-stoppering and re-capping functions, as well as 100% in-process control.

Vial feeding
Here, special attention is paid to meet the requirements for processing specific vials for cryopreservation.

Filling of the objects
We offer you the right product specific filling and dosing technology.
Careful, precise product handling by filling and dosing systems that are optimally matched to suit the product characteristics.
Maximization of product yield as a result of 100 % in-process controls and product saving features

The vials are then closed (stoppering and crimping).
Product-saving features are used for re-stoppering and re-capping.

Finishing the filled vials
Here, the specific requirements of BSL 2, e.g. external decontamination of the vials, can also be accommodated.
Other options: re-nesting, magazining and running vials

OPTIMA pharma Filling Solutions

Robots for Maximum Flexibility

Compact BSL 2-compatible isolator with our Biotech award winning decontamination system
Fully integrated HMI and modular software architecture
Robot platform for the highest levels of flexibility
100 % in-process controls
Innovative technologies to minimize product loss