A new Master Cell Bank (MCB) capable of producing pure cell culture for the manufacture of the anti-biofilm enzyme DispersinB represents a significant breakthrough, according to developer Kane Biotech.
Culture-based production allows manufacturers to make complex biologically active compounds for a fraction of the cost of traditional chemistry approaches. However, because cell cultures are complex great care must be taken to minimise variation between production runs resulting from minor differences in the cell lines used in the process.
Kane, which is a specialist developer of products that prevent and disperse bacterial biofilms, contracted Canadian biomanufacturer BioVectra to develop the MCB in March this year. Since then, BioVectra has been working on a process for the production of clinical grade DispersinB.
Kane believes that the good manufacturing practice (GMP) accredited MCB will provide it with an inexhaustible supply of well-defined culture cells for the manufacture of clinical grade DispersinB for further assessment, development and eventual commercialisation.
"This is a key step in the manufacturing process of clinical grade DispersinB," said Gord Froehlich, Kane Biotech's CEO. "We now look forward to the next step of manufacturing the antimicrobial wound gel using clinical grade DispersinB."
These thoughts were echoed by Scott Doncaster, BioVectra's director of manufacturing, who said: "The successful creation and quality release of the DispersinB MCB represents a significant milestone in the creation of a commercial process for the DispersinB wound gel."
Doncaster went on to say that: "The DispersinB Master Cell Bank was designed to be compliant with the current International Conference on Harmonization quality guidelines for expression constructs of therapeutic proteins (ICH Q5B).
"As the DispersinB wound gel progresses through the developmental phases, this compliance standard will allow for the acceptance of the DispersinB manufacturing process by worldwide regulating agencies."
Increases biofilm susceptibility
Bacterial biofilms are complex networks of interconnected micro-organisms that a can form on and adhere to virtually any solid surface. They can be extremely difficult to remove as they are surrounded by an extracellular protein matrix that protects them from phagocytotic degradation.
As a result, the development of such structures on the surface of implants and medical devices can have severe therapeutic implications, ranging from the development of skin infections to systemic septicaemia.
A recent study, published in the online edition of the journal of Microbial Pathogenesis, suggests that DispersinB can help destroy established biofilm structures.
Specifically the research, which was conducted by Jeffrey Kaplan and his colleagues at the New Jersey University of Medicine and Dentistry, showed that pre-treatment with DispersinB increased the susceptibility of Aggregatibacter actinomycetemcomitans to macrophage-medicated destruction.
"The findings of Dr. Kaplan's group suggest that when DispersinB is used in products such as wound gels and device coatings, either in combination with an antimicrobial or alone, it makes biofilm-embedded bacterial pathogens susceptible to killing by both antimicrobials and macrophages or by our body's macrophages alone," commented Sri Madhyastha, Kane's chief scientific officer.