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How to improve Safety in the production of Cancer Drugs

ProJect Pharmaceutics transforms all kinds of chemical and biological ingredients into pioneering drugs. They are experts in formulation science and pharmaceutical process development with special emphasis on recombinant proteins, Antibody Drug Conjugates (ADCs) / cytotoxics and live virus vaccines. With these innovative agents, a highly cytotoxic agent is linked to a monoclonal antibody, which is intended to direct the active substance to the cancer cells in a targeted manner.

Cancer drugs with highly sensitive active ingredients often require to be freeze-dried to avoid degradation and reduction of 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; also, the higher cleaning effort required and the frequent change of the vacuum pump oil lead to a considerable increase of production costs.

The Lyoprotect® Bag ensures full protection of the product and the environment. The entire assembly 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.

Lyoprotect® Bag

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

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

Thorough tests performed by PJP it is confirmed 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.

lyo cake

Mr. Schütz from PJP says: “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.”

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