News: Press Releases
Fougera® Announces Diversification Of Crofab® Production
Melville, NY – January 19, 2005 – Fougera® Inc. and Protherics PLC announced today the FDA approval of an alternate third party contractor to fill, freeze dry and package CroFab® (Crotalidae Polyvalent Immune Fab -- Ovine). Chesapeake Biological Laboratories Inc. (CBL), Baltimore, MD will fill, freeze dry and package CroFab® in addition to Mayne Pharma, who currently fills, freeze dries and packages CroFab®. As part of this change, wholesalers may notice minor differences in CroFab® packaging, depending on where the product was finished. CBL is based in Baltimore, MD. The following is a list of questions and answers pertinent to this change:
Q. Why is Protherics using two sources to fill and freeze-dry CroFab®
A. The need to have dual sourcing for CroFab® is to minimize the risks to market supply. The goal for CBL is to aid in the production of CroFab®, which will allow for a continuous supply. An additional advantage will be a shorter product supply chain and streamlined logistical activities.
Q. Are there any differences in the lyophilization process at CBL and Mayne?
A. Due to the differences in the actual lyophilizer hardware, some modifications were needed in the freeze-drying process. These modifications are considered minor, and the products produced from either process are equivalent, as supported by the data generated during the CBL qualification program and the ongoing stability trials.
Q. What are differences the between the product finished at Mayne and CBL?
A. The Mayne vial is slightly larger and has a slanted shoulder region while the CBL vial is slightly smaller and has a flat shoulder region. The motivation for changing the vial type is security of supply. The Mayne vial is very difficult to purchase in sufficient volumes and the manufacturer of the vial is a small specialist supplier. The manufacturer of the CBL vial is a major manufacturer and supplies vials of this type for a multitude of products. It is a relatively generic vial type, which helps with securing supplies and controlling costs. The outer carton for the product coming from CBL will be slightly smaller than the outer carton from Mayne, due to the fact that the vials are also slightly smaller and thus require smaller packaging. There is no difference in the color or appearance of the product within the vial.
Q. Will one product have more cake than the other? Will the consistency of the two products be the same?
A. Due to the fact that the CBL product vial is slightly smaller in diameter, a slight increase in the height of the cake may be observed. The cake consistency and appearance is indistinguishable between the Mayne and CBL product.
Q. Will there be any difference in the reconstitution or treatment protocol between the two products?
A. The reconstitution and treatment protocols are the same, as the number of vials per dose and relative total potency per vial is identical between the Mayne and CBL CroFab® products.
About Fougera®
Fougera is a leading manufacturer and distributor of a wide range of multi-source topical and ophthalmic pharmaceuticals in prescription and over-the-counter dosage forms, as well as treatments for emergency/critical care.
About Protherics PLC
Protherics PLC is an international biopharmaceutical company, engaged in the development, production and commercialization of specialist biological products. For more information please visit www.protherics.com.