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Cell and gene therapies Automatable overall solutions for manufacturing and filling

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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?

Facts about OPTIMA pharma
Why you're in good hands with us
Customize platform Select your expandable and device-integrated isolator-based platform
Get more out of it Maximize your product yield with smart and safe technologies
Reduce staff workload Automate labor intensive tasks
Play it safe Rely on entirely safe products and processes 
Stay flexible Work in a highly flexible manner thanks to adaptable process steps and robot technology
Portrait Lars Waldmann
Lars Waldmann, Global Engineering, Thermo Fisher Scientific

Highly sensitive drugs, such as those used in cell and gene therapies, require highly flexible machine solutions with high processing reliability.

Lars Waldmann, Global Engineering, Thermo Fisher Scientific
Products and containers

Smart Solutions for all your requirements

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.

  • Closed system based on proven isolator technology
  • Automation of highly complex process steps
  • Sensitive dosing systems for shear-sensitive products
  • Containment compatible for BSL 2
  • Replicable thanks to automation
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Automated total solutions for cell and gene therapies

Key Facts
In a nutshell: Advantages and technologies
Manufacturing cell and gene therapeutics

ProCell – Solutions for production

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:

  • Modular machine design enables individual combination of processes
  • High process, product and staff safety
  • Operator and product kept completely separate thanks to isolator technology
  • Process automation and automated batch recording possible
  • Adaptable process steps for production
  • Manufacture different products with the same system
Automation within a machine via robot
Manufacturing cell and gene therapeutics

ProCell – Solutions for production

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:

  • Modular machine design enables individual combination of processes
  • High process, product and staff safety
  • Operator and product kept completely separate thanks to isolator technology
  • Process automation and automated batch recording possible
  • Adaptable process steps for production
  • Manufacture different products with the same system
Automation within a machine via robot
Vilma Methner
Vilma Methner, Optima Pharma, Sr. Market Development Manager ATMP

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. 

Vilma Methner, Optima Pharma, Sr. Market Development Manager ATMP

Production process steps for cell and gene therapy

Infographic on process steps in the production of cell and gene therapies

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.

Tailor the automation of your processes
Tailor the automation of your processes
ProCell production platform for cell and gene therapies
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ProCell production platform for cell and gene therapies
Isolator
Opened door of an isolator

The compact, BSL-2 compliant isolator with a decontamination system promises maximum safety for products as well as operating personnel and reduces the surrounding cleanroom class. It was awarded the Biotech Award. 

HMI
Man operates HMI panel on machine

The fully integrated HMI with modular software structure documents processes in an automated and GMP-compliant manner. The fully automatic control system is adaptable within the approved scope. Another plus: You can combine digital solutions such as augmented reality glasses with the HMI.

Automation
Automated control units and robot technology within an isolator

Inside the isolator, automated control units and robot technology ensure maximally flexible, repeatable processes with no need for human intervention.

Centrifuge for cell separation, microscope or pipetting module
Centrifuge for cell separation

Integrate various function modules for an individual sequence and flexible adaptation of your processes. Your advantage: You can manufacture and fill the cell and gene product in the system. In addition, your system can also manufacture several products simultaneously.

Material transfer chamber and ports between a laminar flow unit and the isolator
Material lock and luminar flow unit

Enable fast and safe transfer of patient or consumable supplies and other preparatory work.

Logo ProCell

ProCell

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.

Logo Landesregierung Baden-Württemberg

State of Baden-Württemberg

The “ProCell for Patient” project for the automated production of CAR-T cell therapies is required by the state of Baden-Württemberg.

Logo Forum Gesundheitsstandort

Forum for health and wellness

The forum for health and wellness in Baden-Württemberg supports the “ProCell for Patient” project.

Vilma Methner
Do you have questions or specific requirements in the field of cell and gene therapy? Talk to Optima's experts about your project.
Vilma Methner
Optima Pharma, Sr. Market Development Manager ATMP
+49 791 9495-0 customer.info@optima-packaging.comWrite e-mail
Vilma Methner
Vilma Methner
Optima Pharma, Sr. Market Development Manager ATMP
FillCell – Filling cell and gene therapeutics

Safety to maximum yield

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:

  • A highly-flexible system and robotics platform
  • 100 % inprocesscontrol
  • Technologies maximize product yield
  • Proven isolatortechnology ensures safety
  • Containment compatible for BSL 2
Vial Filling
FillCell – Filling cell and gene therapeutics

Safety to maximum yield

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:

  • A highly-flexible system and robotics platform
  • 100 % inprocesscontrol
  • Technologies maximize product yield
  • Proven isolatortechnology ensures safety
  • Containment compatible for BSL 2
Vial Filling
FillCell – Filling for cell and gene therapy

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.

An overview of the process steps for filling cell and gene therapeutics
  • 1. Feed
  • 2. Filling
  • 3. Closing
  • 4. Discharge
Next
Infeed process pharma line
1. Feed

First, vial feeding takes place. The object feeder is also designed to process specific vials for cryopreservation.

Vial Filling
2. Filling

We precisely match filling and dosing technology to each product, which means you can rely on gentle and precise handling. Integrated functions ensure maximum product yield.

Process vial closing
3. Closing

The vials are usually closed by plugging and crimping. In this context, product saving features also prevent product losses.

Ejection of vials within a pharmaceutical machine
4. Discharge

When the process is complete, the filled and sealed vials are magazined and discharged.

An overview of the process steps for filling cell and gene therapeutics

1. Feed
Infeed process pharma line

First, vial feeding takes place. The object feeder is also designed to process specific vials for cryopreservation.

2. Filling
Vial Filling

We precisely match filling and dosing technology to each product, which means you can rely on gentle and precise handling. Integrated functions ensure maximum product yield.

3. Closing
Process vial closing

The vials are usually closed by plugging and crimping. In this context, product saving features also prevent product losses.

4. Discharge
Ejection of vials within a pharmaceutical machine

When the process is complete, the filled and sealed vials are magazined and discharged.

Automated for maximum filling flexibility
Automated for maximum filling flexibility
Machine solution for cell and gene therapies: Automated for maximum flexible filling
Isolator
Turnkey approach
Mobile glove testing system
Robotics
100 percent in-process controls
Product recovery
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Machine solution for cell and gene therapies: Automated for maximum flexible filling
Isolator
Pharma machine with isolator

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. 

Turnkey approach
CSPE info graphic

The filling machine with isolator from a single manufacturer, in combination with the CSPE approach, simplifies your project handling. Prior to delivery, we commission your system and test it in all respects. This allows you to start production safely and immediately.

Mobile glove testing system
Mobile glove testing system for isolator gloves

With the mobile glove testing system, you perform the leak test for gloves automatically – reliable, flexible, and easy to use.

Robotics
Use of robotics Cell and gene therapies

The use of robots enables a maximally flexible system and an automated, replicable production sequence. This increases your safety and reduces the workload of your staff.  

100 percent in-process controls
Vial Filling

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.

Product recovery
Control device within a machine that minimizes product ejections

Comprehensive product saving functions (e.g. redosing, restopping, recapping) minimize rejects, thus enabling you to fully utilize the available amount of product.

Reference project Thermo Fisher Scientific
Vilma Methner
Do you have questions or specific requirements in the field of cell and gene therapy? Talk to the experts at Optima about your project
Vilma Methner
Optima Pharma, Sr. Market Development Manager ATMP
Vilma Methner
Vilma Methner
Optima Pharma, Sr. Market Development Manager ATMP
+49 791 9495-0 Write e-mail
Vilma Methner
Do you have questions or specific requirements in the field of cell and gene therapy? Talk to Optima's experts about your project.
Vilma Methner
Optima Pharma, Sr. Market Development Manager ATMP
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