The biopharmaceutical industry has seen a major shift away from the use of serum and other animal-derived components in the manufacture of biopharmaceuticals. Guidance from the EMEA and FDA for the manufacture of biopharmaceuticals and medical devices encourages the use of “animal free” components to lessen concerns over contamination from adventitious agents such as prions, a cause of spongiform encephalopathy…
Tag: <span>productivity</span>
The “Lean” manufacturing process management methodology is derived largely from Toyota Motor Corporation’s automotive production system, implemented as a response to the problems they observed within their production facilities over 50 years ago. The principle of reducing costs by eliminating waste—also known as “Lean Thinking”—has been gaining momentum as a continuous improvement philosophy for all sorts of industries outside of its automotive industry origins. In recent years, we have seen several examples of successful Lean implementations in the pharmaceutical and biotech companies. Multinational corporations such as Merck, Pfizer, and GlaxoSmithKline have reported significant gains by applying Lean not only to manufacturing, but also in critical areas like quality control, regulatory adherence, and administration management…
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…
Within the biopharmaceutical industry, mammalian cell culture is extensively used to manufacture a various biopharmaceutics uncluding antibodies, interferons, hormones, crythropoietin, clotting factors, immunoadhesins, and vaccines. The market for monoclonal antibodies (MAbs) alone is expected to grow 30% a year and reach sales of nearly $6.5 billion in 2004. The vast majority of these biotherapeutics are secreted glycoproteins obtained from mammalian cell lines such as: Chinese hamster ovary (CHO), human embryonic kidney 293 (HEK-293 or 293). NS0, and baby hamster kidney (BHK). As is the goal with most commercial products, biotechnologists strive to generate these valuable proteins in the highest yields possible in order to utilize mammalian bioreactor facilities efficiently…
Process development is an investment. As with a personal retirement plan, the importance of making the investment is not in question, yet strategies for when, how much, and where to invest in process development vary significantly from company to company. For a personal retirement plan, the answers to these questions are straightforward: invest as early as you can and as much as you can, and take less risk the closer you get to retirement. This would also be sound advice for investing in process development (substituting “BLA filing” for “retirement”) were it not for two complicating factors. First, the majority of biotherapeutics that enter the clinic fail to make it to the market. This makes a large, early investment in process development less attractive. Second, there is extreme pressure to get into the clinic, and subsequently onto the market, as quickly as possible, minimizing the time available for process development…
Peptones are protein digests composed mainly of amino acids and small peptides. Peptones have been used in mammalian cell culture medium as a serum substitute to enhance cell growth and product formation. The first part of this study describes our evaluation of peptones from different sources (soy, wheat, yeast, and casein) on the cell growth and productivity of Sp2/0 myeloma cells expressing recombinant prourokinase (r-ProUK). The results of these studies demonstrated that wheat peptone was the most effective plant peptone to increase r-ProUK yield. Addition of 2 g/L wheat peptone to the culture medium increased batch r-ProUK production between 28-67% compared to cells grown in the absence of peptone supplements. Peptones did not increase cell productivity, but increases r-ProUK yield through increased culture longevity…