lyoprotect

Numaferm GmbH uses Teclen® Lyoprotect® Bags to avoid Fly-out of Peptides

Anja Busch Case Study
Lyoprotect Bag with Vials in a Trays

Lyoprotect Bag with Vials in a Trays

About Numaferm GmbH

Founded in 2017, Numaferm GmbH has become a first-rate, trusted partner in the field of recombinant expression of peptides and proteins.

The team of about 30 experts, including 15 Ph. D. level scientists, has collectively cumulated more than 100 years of expert knowledge in the field of process development and production. The generous laboratory facility is equipped with state-of-the-art technology and hence offers excellent conditions for the development of fast, cost-efficient and resource-friendly production processes for the manufacture of high-purity products.

Within the framework of technology platforms developed by Numaferm, such as NumaswitchTM, cells of the Escherichia coli bacterium are reprogrammed to produce the desired peptide / protein. These patented processes rank among the most successful ones in the market, also because the costs are only one-tenth of the chemical synthesis. In addition, Numaferm has recently commercialized its first own enzyme product NumacutTM TEV protease. This means that the innovation and development work, which has so far only been utilized inside the company, is now also accessible to clients and partners.

NumacutTM TEV protease is a highly active, optimized variant of the Tabacco Etch Virus (TEV) protease with widened substrate tolerance and high stability. In order to ensure a high storage stability and a more environmentally friendly and cost-efficient transport, NumacutTM TEV protease is lyophilized and can subsequently be shipped at room temperature.

 

Initial Situation

In the present production process, enzyme products, such as NumacutTM TEV protease, were to be shipped as lyophilisate to the customers. Top priority was a consistent product quality. The liquid formulation was to be filled into vials suitable for shipment, with subsequent lyophilization.

During lyophilization handling, fly-out and concomitant product loss as well as any contamination of the products or environment were to be excluded. After lyophilization, the vials were to be closed with their stoppers.

 

The Solution: Lyoprotect® Bag

Dr. Christian Schwarz got in touch with Teclen GmbH in order to find out how Lyoprotect® Bags can be used for lyophilization in vials. The customizable bag sizes were a big asset, as well as the Lyoprotect® Membrane’s minimal impact on the drying conditions in comparison to an open vial, and of course also the excellent barrier properties of the Lyoprotect® Bag.

The vials are filled in a storage box and are then placed into the Lyoprotect® Bag, which is already in place in the freeze-drier. The bag is then closed and secured with the closing stick. When the freeze-drying process is finished, the vials can be securely closed by means of an auxiliary plate.

Numaferm GmbH has successfully been using Lyoprotect® Bags in the lyophilization of liquid peptide formulations in preparative quantities for quite some time now.

 

Dr. Christian Schwarz, Numaferm GmbH
Dr. Christian Schwarz,
CEO at Numaferm

 

“Using the customized Lyoprotect® Bags improves not only product handling but also staff safety with regard to fly-out. The various Lyoprotect® Bag sizes allow for maximum flexibility with different batch sizes and fillings – both equally important for our service and product business.“

 

 

 

 

 

NumacutTM is a trademark of Numaferm GmbH.
More information about the product of Numaferm GmbH: NumacutTM TEV Protease

 

Check out more details about the Lyoprotect® bags and the process with vials!

 

Contact us for questions or your unbinding quote!

 

 

Cilian Uses the Lyoprotect® Bag Direct Fill to Protect their Staff

Anja Busch Case Study

Lyoprotect® Bags Protect Operators from Enzymes Causing Respiratory Irritation

 

Lyoprotect® Bag Direct Fill

 

About Cilian AG

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

Anja Busch Allgemein
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 pharmaceutical 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 of Pharmaceuticals

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

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