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
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
for Cell and Gene Therapies
Production Solutions
for Cell and Gene Therapies
for Cell and Gene Therapies
Process Steps in the Production of Cell and Gene Therapies
How We support You
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.
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
for Cell and Gene Therapies
Filling Solutions
for Cell and Gene Therpies
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
We are Your Partner
We are Your Partner
The right Solutions for Your Requirements
Different Areas of Application and Container Types
Your
needs
needs
Product
- Viral vectors
- Cell therapies
- Gene-modified cell therapies
- Suspension cells, e.g. CAR-T
- Adherent cells
Containers
- Cell culture flasks
- Cell culture bags
- Filling in bags
- Filling in vials
OPTIMA
Smart Solutions
Closed system
based on proven isolator technology
based on proven isolator technology
Performance
small to medium batch sizes
small to medium batch sizes
Production time
optimized for cryopreserved products
optimized for cryopreserved products
Dosing systems
for shear-sensitive products
for shear-sensitive products
Containment
compatible with BSL 2
compatible with BSL 2
Automation
for a high level of reproducibility
for a high level of reproducibility
More about this Topic
Read our Technical Article "A Finger on the Pulse of the Future" now
More background information on cell and gene therapies, the hopes connected with them, as well as current market research data and all the features of our system solutions for manufacturing and filling can be found in our technical article "A finger on the pulse of the future".
