Since the first approval for human use of a recombinant protein therapeutic, this sector of the pharmaceutical market has grown rapidly. The first approved protein therapeutics were small, non-glycosylated proteins such as insulin and human growth hormone; they were produced in bacterial systems. With the advent of mammalian cell-based production systems, it became possible to produce more complex, glycosylated proteins for use as recombinant therapeutics…
Category: <span>Biologics Production</span>
Optimization of the key factors in a biopharmaceutical process is necessary to meet the continuous rise in the production demands. One of the key factors in the process addresses the diverse nutritional and growth requirements of the cell culture—peptone supplementation. Peptones are low molecular weight protein digests, which provide nutrients such as amino acids, peptides, vitamins, and minerals to the culture medium. They are widely accepted as the supplements that enhance the performance of a chemically-defined cell culture medium, and have successfully been used for over thirty years…
Today, many if not all of the major pharmaceutical companies have specific budgets for large research and development pipelines for new biologics including vaccines, monoclonal antibodies, recombinant proteins and even gene therapy projects. In addition, small innovative companies are continually presenting us with novel treatment opportunities which hold great promise for the future. The reason for such huge optimism in the field of biologics is that there are now a number of “blockbuster” drugs for which the safety profile has been very successfully managed. This success has been achieved following a considerable amount of time and financial investment by both the innovators and the regulators…
Humans have enjoyed large-scale protection against many infectious and contagious diseases since 1796, when Edward Jenner first introduced a vaccination against smallpox by an active immunization technique. Vaccination has proved itself to be the most successful solution for preventing the occurrence of many infectious diseases that previously caused serious illnesses, post-recovery ailments, and even death (e.g., smallpox, diphtheria)…
Despite the existence of effective vaccines against Hepatitis B virus, the infection with it remains an important problem worldwide due to its association with hepatocellular carcinoma. Several procedures have been used to purify the Hepatitis B surface antigen (HBsAg) for immunization purposes. Immuno-purification using HBsAg-specific murine monoclonal antibodies (MAbs) has been one of the most successful strategies for such a purpose due to the high antigen selectivity (high affinity) of MAbs…
In order to unravel new protein activities and functions, we have expressed and purified a large number of human proteins. We have chosen to study secreted proteins and the extra-cellular domains of putative single transmembrane domain-containing proteins. In order to retain the natural protein characteristics as far as possible, we have used a mammalian expression system. Human embryonic kidney (HEK293) cells were chosen as they have been shown to possess a high protein-secretory potential. The secreted proteins were expressed with a carboxy-terminal tag and purified by affinity chromatography. Each protein was produced at a routine scale from 500 ml cell cultures, and the secreted protein was purified from the culture supernatant…
With the continued growth of the biopharmaceutical market, the cell culture industry has seen a major shift away from the use of serum and other animal-derived supplements in the manufacture of biopharmaceuticals. Indeed, supporting guidance from the EMEA and FDA for the manufacture of biopharmaceuticals and medical devices encourages the use of “animal-free” components. The key driver for this can be attributed to the increased concern with contamination from adventitious agents such as transmissible encephalopathies…
Electrosprays and electrospinning are two interrelated physical phenomena which have been investigated for well over a century. Their similarity is based upon the primary driving mechanism; namely, the applied electric field. However, they have a fundamental difference that distinguishes one from the other: the former generates droplets while the latter forms continuous fibres. These two processing routes have been extensively researched in many areas. Within the realm of life sciences, these routes have ranged from novel bioanalytical approaches (DNA and biomolecules) to tissue engineering by the formation of scaffolds, which mimic extracellular matrices. Only lately have these methods been explored for the direct process handling of living cells…
When analyzing the complete market for human diagnostic products, with an estimated value of $30 billion annually, the $2 billion market for molecular diagnostic methods is still relatively small. However, with a growth rate of 20% per year, this segment is growing faster than any other in in vitro diagnostics. The reason for this is that healthcare systems have just begun tapping the tremendous potential to which this new technology gives us access. Whereas in the past, large reference laboratories and academic teaching hospitals were the driving force, today the customer base is increasingly made up of smaller diagnostic labs and clinics. Other features of the market are the wide-reaching protection of intellectual property and high product values, due to the significantly higher development and production costs…