Compliance Resources to Help you Stay Current

On February 9, 2012, the FDA released draft guidelines about quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and are based on key scientific and regulatory factors which should be considered for submission of applications for bio-similar products to the FDA.

On February 9, 2012, the U.S FDA released draft guidelines about scientific and quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and provide an overview of FDA’s approach in determining bio-similarity of a biologic product.

The American Red Cross, which supplies 40 – 45% of donated blood in the U.S., was recently fined by the FDA for substandard and unsafe practices on blood management and for failing to rectify these violations. This article details the reasons behind the FDA fine and the laws that were violated.

In October 2011, the FDA issued final guidance on Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Prescription Drugs and Biological Products. The aim of the guidance is to help ensure that labeling is clear, useful, informative, and to the extent possible, consistent in content and format.

This article gives a brief overview and summary of the recommendations contained in the guidance.
 

The European General Product Safety Directive (2001/95/EC) directive covers nearly all products sold in the European Union. It places responsibility on suppliers of consumer goods to make sure their products are safe for normal and foreseeable use. The directive also requires producers to supply consumers with relevant information that enables them to assess the risks inherent in that product.

Warning letter sent to Jilin Shulan Synthetic Pharmaceutical Co. regarding significant deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs.

Viral Safety Evaluation is the process that used to evaluate the safety of a manufacturing production process to inactivate and/or remove potential viral contaminants.

All biotechnology products derived from cell lines face the risk of viral contamination. This article describes the standards for controlling viral contamination in biotech products, viral safety principles and regulatory guidelines.

Pharmaceutical Biotechnology industries must maintain quality assurance software in compliance with FDA regulations, and quality management. Biotech companies may also opt to adopt ISO 9000 and ISO 14001 systems.

For the Waisman Clinical BioManufacturing Facility (WCBF) at the University of Wisconsin-Madison it is important to maintain strict cleanroom cleanliness and sterility in their Class 7 and 8 cleanrooms. If contaminated with microorganisms, the products the WCBF manufactures can adversely harm patients. In addition, the steep price of product rejects and recalls makes it crucial to ensure high product yields.

Sickle-cell disease, or sickle-cell anaemia (or drepanocytosis), is a genetic life-long blood disorder characterized by red blood cells that assume an abnormal, rigid, sickle shape. Sickling decreases the cells' flexibility and results in a risk of various complications. The sickling occurs because of a mutation in the hemoglobin gene. Life expectancy is shortened, with studies reporting an average life expectancy of 42 and 48 years for males and females, respectively.

This condition has been successfully treated in children by way of bone marrow transplants. Treatment has been evading adults as there has been a lack of healthy sibling donors as there is a risk rejection when transplants are made from unrelated donors. The current treatment has been found to be very harsh on adult patients. Researchers have successfully conducted a bone marrow transplant to cure this sickness in adults which has raised hopes for a big number of US patients. The initial results have been promising as the researchers claim to have cured 9 out of 10 patients. Research is still on to test similar treatment from unrelated donors.

Stem cells have been researched for more than a decade now to realise their capabilities in fighting diseases from within. The challenge of isolating and growing these cells in lab environments has resulted in further research of how these can be applied to treat diseases. Till date stem cells have been isolated form the marrow and has been used in regenaeration of blood cells post leukemia or lymphoma. More intense research is on to understand the potential of adult stem cells in treating various diseases.

Stem cells are being researched for treatment of various diseases due to their regenerative capabilities. They function as internal repair systems. Stem cells differ from other cell types by two important characteristics. First, they are unspecialized cells capable of renewing themselves through cell division, sometimes after long periods of inactivity. Second, under certain physiologic or experimental conditions, they can be induced to become tissue- or organ-specific cells with special functions. In some organs, such as the gut and bone marrow, stem cells regularly divide to repair and replace worn out or damaged tissues. In other organs, however, such as the pancreas and the heart, stem cells only divide under special conditions. Recent developments in stem cell research wherein cells derived from umbelical cord blood has shown promising results in lab tests for regeneration of damaged lungs and further research is being made to extend this to repair disfunctional heart.