One of the fundamental foundations of bioprocess system design is the use of “closed” systems for production. Closed systems and equipment are utilized to prevent contamination of the product. They are also used as a means of containment to protect not only the product, but also workers and the facility environment. The concept of a closed processing system makes common sense. What is surprising is how closed systems are defined and referenced within the body of regulatory guidance documents and how companies differ in their implementation of a “closed manufacturing” concept. What is not surprising is the impact that closed systems have on facility design…
BioProcessing Journal Posts
R&D output continues to climb with advances in laboratory automation and data analytics but, when measured in terms of the number of drug approvals versus expenditures, the productivity of R&D has been in decline. This paradox confounds many organizations as they struggle to improve. A common strategy has been to invest in informatics. These investments are meant to increase the effectiveness and speed of the decision-making process in which validated findings are compared against predicted outcomes — to close the loop between design and experimentation. But the loop has not been closed in a broad and coherent way, and increased productivity has not been achieved. Instead, the information management landscape in life sciences R&D has remained fragmented, with barriers between disciplines and geographies that prevent broad-based productivity gains…
The manufacture of biological materials by fermentation is based intrinsically on established and well understood processes developed over a number of years. The fundamental basics of supplying a characterised cell line with sufficient nutrients over a period of time, with the intention of harvesting a selected protein for further processing, are similar throughout the industry. However, as a result of economic pressures and the need to control costs of an already expensive, high quality, and high compliance material, all manufacturing companies endeavour to maintain the highest level of productivity…
It has been reported that the biotechnology-derived medicines area of the pharmaceutical industry led to 133 marketed entities with sales of $22 billion by the year 2001. By 2002, the therapeutic protein market had reached $32 billion, with biologics representing more than 50 percent of all drugs approved by FDA — up from a modest 16 percent in 1995. The biopharmaceutical market is predicted to grow to $50 billion by 2008. Currently, approximately 40 percent of biopharmaceutical products are in Phase I and Phase II clinical trials. It is anticipated that from 2003 to 2008 there will be a more than 45-fold increase in demand for access to product development facilities capable of supplying clinical material…
The Intraocular Delivery of Neuroprotective Factors to the Retina Using Encapsulated Cell Technology
Ophthalmic disorders are a group of diseases with a rapidly increasing frequency associated with an increase in the aged population. Patients with potentially blinding diseases have become one of the largest segments of the healthcare field, with more than 50 million patients in the United States alone. Their sight is threatened by diseases such as age-related macular degeneration (AMD), diabetic retinopathy (DR), glaucoma, or retinitis pigmentosa (RP). Until recently, there were essentially no effective treatment options to halt the progression of chronic, potentially blinding diseases. Biotechnological advances have resulted in the development of a variety of promising new protein factors that, if delivered to diseased cells of the retina, hold promise for treatment by interrupting or reversing the disease process…
Regulations and common sense require that a manufacturer qualify both the raw materials and the suppliers the firm will use to produce GMP supplies of a pharmaceutical or biopharmaceutical. Because the firm is accepting legal liability for the quality of all raw materials, it makes good business sense to devote resources to these activities. This article explores how to assure that qualification is complete, efficient, and compliant with current good manufacturing practice (cGMP), and discusses the challenges faced by today’s manufacturers…
Proteins and their promise for revolutionizing drug discovery have come virtually full circle in just a few decades. The advent of genetic engineering and the emergence of early recombinant proteins such as insulin and interferon dramatically boosted the perceived value of proteins in pharmaceutical research and of protein drugs in particular. Although the lights dimmed somewhat on the promise of therapeutic proteins in subsequent years, more recent times have seen a resurgence of interest in proteins, particularly monoclonal antibodies. Perhaps most telling has been the dawn of the post-genomic era, which has cast a bright spotlight on proteins, long respected as the work-horses of the cell, for their usefulness in exploring cell function, unraveling biochemical pathways, understanding disease, and for their massive value as novel drug targets…
Several developing countries, including India and China, have young biopharmaceutical industries that have based much of their growth potential on the production of what are currently known as “biogeneric” products, or “bioequivalent” versions of biologics that have already been licensed in Western countries. With a disdain for foreign patents, an established philosophy of copying Western innovations, and success in generic pharmaceutical manufacturing, this approach appeared to be the logical way to build a biologic manufacturing industry. However, there are numerous problems with this development strategy. First and foremost is the inherent incompatability of the very concepts associated with biogeneric products…