lyophilization

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!

 

 

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

ProJect Pharmaceutics uses Teclen Lyoprotect® Bags for Contamination-free Lyophilization

Anja Busch Case Study

ProJect Pharmaceutics uses Teclen Lyoprotect® Bags for lyophilization of innovative cytotoxic drugs

Managing directors PJP

 

ProJect Pharmaceutics GmbH (PJP) offers optimized formulation and process development for pioneering drug products to the international pharmaceutical and biotech industry. PJP was founded in 2010 and is located in Martinsried / Munich. The company has become the leading European service provider for the pharmaceutical development of cancer drugs, especially of so-called Antibody Drug Conjugates (ADCs). With these innovative agents, a highly cytotoxic agent is linked to a monoclonal antibody, which is to direct the active substance to the cancer cells in a targeted manner. For this type of drugs, PJP does not only develop formulations but also efficient and robust manufacturing processes, which are scaled up from in-house pilot installations to industrial sterile manufacturing. In the process, PJP pursues a consequent “Quality by Design” approach, so that the drugs can be processed smoothly and in consistent high quality in the production plant.
The PJP team approached Teclen GmbH, who offers different products for contamination-free lyophilization, with this problem.

Initial situation

Freeze-drying is an essential step in the development and manufacturing of many drugs in order to increase the stability of active ingredients and to get a storable finished drug product. Especially cancer drugs with highly sensitive active ingrediences often imperatively require freeze-drying to avoid degradation and reduction of the effectiveness during storage. So far, the products have been freeze-dried in open glass vials. In this process, the contamination of the freeze-drier by potential fly-out of toxic material from the vial or by glass breakage poses a risk for the staff, and the higher cleaning effort and frequent change of the vacuum pump oil leads to a considerable increase of production costs. Trials to seal the lyophilizate in sterilization bags and to perform lyophilization from within such more or less gaspermeable bags were not successful. The considerable obstruction of the sublimate downflow at the bag’s membrane leads to massive changes in the process quality – efficient lyophilization is no longer guaranteed.

The solution: Lyoprotect® Bag
Lyoprotect bag contamination-free lyophilization of ADC
Lyoprotect bag for freeze-drying

When Dr. Andreas Schütz of PJP explained their present approach to Rolf Lenhardt of Teclen GmbH, a joint solution was found within no time:

The freeze-drying process was to be identical to the lyophilization process in an open vial to the extent possible. At the same time, it was to ensure total protection of the product and the environment. The specific Lyoprotect® Bag offers this advantage:
The entire assembly (usually a metal tray) of the vials can be inserted into the bag, the open side is closed with a special clip system. Subsequently, lyophilization of the vials is possible with exactly the same drying parameters used for lyophilzation with open containers. It has been demonstrated that there is no obstruction of the sublimate downflow. Depending on the  requirements, the bag can be sterilized in an autoclave before it is filled.

For vials and bulk

The Lyoprotect® Bag is characterized by an excellent vapor permeability; at the same time it reliably prevents bacteria, germs or particles from passing through the membrane.

As the Lyoprotect® Bag is very flexible, the vials can also be closed directly in the bag with the lyo-plugs by lowering the shelves, thus securely closing the vials.

Thorough tests performed by PJP confirm the excellent suitability of the Lyoprotect® Bag for lyophilization. By means of extensive test series, it was possible to verify the particle tightness of the bags even under extreme conditions. The drying process of sample vials within the Lyoprotect® Bag was completely equivalent to the drying process with open vials. PJP now uses Lyoprotect® Bags for all projects with toxic ingredients and for all batches for the production of sterile preclinical samples.

 

Dr. Andreas Schütz, Managing Director at PJP“We’d already tried out several sterilization bags, but always had to compromise on the drying parameters. With Lyoprotect® our drying philosophy of the Single-Step-Cycle can now be realized much better – we also consider the Lyoprotect® system fit for GMP production of lyophilized drugs.” (Dr. Andreas Schütz, Managing Director at ProJect Pharmaceutics)

 

 

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