ATMP Solutions Catalogue

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Increase your asepsis and contamination control!
Decrease your costs and energy consumption!

The Comecer ATMP Catalogue: experience gained over time

ATMP facts

Manipulation and treatment of biological medicinal substances and of Medicinal Products for Advanced Therapies (ATMP) require specific knowledge for cell manipulation, expansion, and related operations. These products require highly demanding environmental conditions to ensure compliance with sector-specific GMP (Good Manufacturing Practices), in addition to pharmaceutical regulations. The process is based on the ability to build segregated aseptic environments (ISOLATORS) where processes can take place under Grade A of cleanliness, according to the existing pharma and most recent ATMP regulations. One of the challenging points is the integration of unconventional devices, quite different from the configurations which apply in the chemical pharma industry, needed for specific operations to be performed on cells (heaters, incubators, refrigerators, freezers, centrifuges et cetera). Peculiar requirements involve the ability to make the machine-friendly, easy to use, stable, safe for product and operator, cost-effective in time, and labour management.

How Comecer contributes

• Dedicated workforce for interaction and consulting with customers for defining the best solution: understanding customer processes, space, useful options required, time constraint evaluations, and more.
• In-house manufacturing of cell therapy isolators, according to the highest technical standard specifications for pharma-grade equipment.
• Specific capabilities in integrating into isolators different specific devices for the ATMP applications, a large part of them uniquely developed and consolidated in several successfully delivered projects.
• Ownership of several patents for connectable equipment to be used in conjunction with Comecer Isolation Technology: among all a Grade A Mobile Incubator
  (Flexycult™).

Comecer sales engineering and concept study service

Dealing with a new application or an existing application and a different manufacturing approach is always challenging for both the customer and the manufacturer.
The initial phases of a new project involve a focus on preliminary analysis, sales engineering, and mock-up. In some cases, the exercise is simple (the scope of the project is well defined and
the URS already in place and complete in full). In other cases (complex/multi-tasking projects, important technology transfers, need for additional business case studies) the concepts outlined here can be an independent project and they can also be individually sold. The detailed design phase relies on a multidisciplinary team, where different skills and expertise are put together in order to address the full range of possible issues of the project and identifying the best solutions for each of them.

Additional services

• Plant Capacity
• Calculating plant capacity (i.e. the maximum number of batches you can process) with the identified configuration
• Finding bottlenecks and suggesting improvable points
• Suggesting final plant configuration and changes to be done for matching a specific batch release target
• Alternatively – which configuration with the given modules do we need to produce a certain number of batches?

Download the ATMP catalogue with case studies of solutions and systems includes:

• A compact isolator for manipulation of large cultivation items (i.e. Cellstacks), with flexible fast decontamination chamber, suitable for scale-out in a multiple locations production setup.
• A stand-alone system for multiple parallel processes – e.g. Sample management and MSC processing in a Cord Blood Bank. With flexible material insertion, shared and dedicated areas, all-in-one device integration.
• A stand-alone system – recommended for local production (e.g. Hospital Cell Factory) – large configuration.
  Three working areas: material insertion (left), main
  processing area (center), incubation (right).
• A modular and scalable structure for an industrial setup. Mobile incubators in rack, connectable in the most flexible way to a set of isolators.
  Automation, procedural support, track, and trace.

Compact and flexible systems for multiple applications

The continuous challenges posed by the incoming new applications and the progress of technology drives Comecer to a constant renewal of  our isolator solutions for ATMP.

• New content with different configurations: from small stand-alone solutions to scalable industrial applications
• Innovative technical and procedural approaches cover the largest demand
• Services and options for project development from basics
• Updated reference list with cases and challenges description: learning from success!

Find it all in our ATMP Catalogue, fill in the form to request your copy!