lyoprotect

Cilian Uses the Lyoprotect® Bag Direct Fill to Protect their Staff from Enzymes Causing Respiratory Irritation

Lyoprotect® bag for direct filling Closing System

Cilian AG is an innovative biotechnology enterprise, which uses the unique abilities of Ciliates for the industrial production of therapeutically effective recombinant proteins. The company is working on the production of vaccines, monoclonal antibodies as well as on oral preparation for the substitution therapy of pancreatic insufficiency.

By using a new class of production organism (Ciliates) Cilian AG can create a substantially safer, more efficient and more cost-effective production process as this is currently possible for comparable proteins with mammalian cells. Moreover, it is expected that monoclonal antibodies are significantly more effective. Cilian AG is offering this unique technology as CIPEX-System to pharma and biotech companies.

Initial Situation

In their planned production process Cilian AG uses enzymes which can cause irritations of the respiratory system. For this reason, protection of the staff is of the highest priority when freeze-drying these active ingredients.

The product is to be placed in liquid state into a container for lyophilization. Afterwards, it is to be transferred in dried state to a processing co-operation partner. The pack size should be as small as possible for temporary storage before processing. Since a reusable container for freeze-drying would entail an elaborate cleaning process, a single-use solution is more suitable in the current development phase.

The Solution: Lyprotect® Bag Direct Fill

When Dr. Ingo Aldag, project manager at Cilian, had explained the performance requirements in a meeting with Teclen, different options were discussed.

It became apparent that the most suitable solution would be a small bag which would fit into a laboratory freeze-drier and could directly be filled with the product and then securely be closed. Once closed, the bag can be handled safely and without effort, and the staff doesn’t come into contact with the enzymes. The small size and flexible form of the bag allows for a space-saving storage of the dried product. The dried enzyme remains in the Lyoprotect® Bag and is additionally sealed in another light-proof and gas-tight storage bag.

In order to take out the product for processing, the outside bag is opened and the Lyoprotect® Bag is emptied or extracted under a laminar flow cabinet.

 

Dr. Ingo Aldag, Cilian

“Especially in the DSP development phase, the flexibility regarding bag sizes as well as the rapid availability were decisive factors in favor of the Lyoprotect® Bag. Since open handling with enzyme dusts were viewed as critical, the Lyoprotect® Bags were the ideal solution. For meanwhile two years, we have routinely employed these bags for the lyophilization of enzyme test batches and in process optimization.

 

 

 

 

 

 

 

Contamination-free Lyophilization with Vials in a Bag

Contamination-free Lyophilization with Vials in a Bag

During regular freeze-drying in vials you still have the implication of product loss and fly-out. In addition, the staff and product are under contamination risk.
Further, aseptic development and/or manufacturing for clinical studies is difficult and expensive to achieve.

The Teclen® Lyoprotect® Solution for Contamination-free Lyophilization with Vials in a Bag

A tray (or frame) is used to accommodate the filled vials. These are arranged in the middle of the tray, and the stoppers are in the drying position. Open space in the tray should be filled with empty vials. The vial/tray assembly is placed into a Lyoprotect® Bag, which is closed and secured with the closing stick.

If aseptic criteria must be met, filling of vials, placement and closure of the Lyoprotect® Bag need to take place under a laminar flow / at a work bench. All required accessories (vials, stoppers, bag etc.) must be sterile. When the bag is closed, the assembly can be moved to a freeze-drier in the facility.

When the drying process is finished, the vials are securely closed with the stoppers. This is done within the freeze-drier by lowering the shelves. The flexible materials of the Lyoprotect® Bag follow the movements and mechanical loads when the stoppers are pushed in. If decontamination of the outside of the vials is needed (e.g. H2O2), this can be done with the bag still in place. After decontamination you can remove the closed vials for crimping.

 

Contact us: sales@teclen.com