Tag: <span>cost reduction</span>

‚ÄúClosed system.‚ÄĚ The term itself appears deceptively simple. However, the definition of a closed system, its implementation, and its impact on biomanufacturing has been anything but straightforward.

The journey toward implementing closed systems spans over 20 years. The concept of closed systems was introduced in January 2000 with the draft issue of ICH Q7. Since then, other industry guidance documents emerged, defining and supporting process/system closure as a primary means of risk mitigation to meet the baseline requirement of protecting the product, as defined in cGMP.

Presently, global regulatory agencies recognize three distinct definitions of a closed system. These definitions, found in EU Annex 1, EU Annex 2, and the PIC Annex 2A, all focus on product protection where the product is not exposed to the immediate room environment during manufacturing. This is where the journey begins.

Manufacturing Risk Analysis and Management

How much new business does it take to add $100,000 or even $1 million to the bottom line? Even with tax deadlines looming for companies that filed extensions, there is still time to maximize the benefits of all available tax credits and incentives. A powerful tax incentive known as the research and development (R&D) tax credit is available in the United States at both the federal and state levels to help manufacturers recover a significant amount of R&D costs…

Manufacturing Research

A basic engineering study has been performed to evaluate three different strategies for the production of monoclonal antibodies (MAbs) from Chinese hamster ovary (CHO) cells. Cells are expanded in suspension culture and are then inoculated into either fed batch or perfusion culture for MAb production. The first strategy, which is also the current industry standard, uses fed batch culture with the cells in suspension in a stirred tank fermenter. The second strategy uses perfusion culture with the cells immobilized on Cytopore‚ĄĘ microcarriers in a stirred tank fermenter. The third and final strategy is perfusion culture with Cytoline‚ĄĘ microcarriers in a fluidized bed fermenter. Perfusion cultures, while leading to a somewhat lower product titer, were characterized by a much smaller equipment footprint. This in turn led to a >30% reduction in investment costs and a 12% reduction in MAb production costs calculated over five years of depreciation and ten years of production time‚Ķ


Building a MAb bioprocessing plant is a process which normally takes three years. Before starting the engineering work, a ‚Äúlocked‚ÄĚ process is ¬≠necessary. This means that all the steps have to be defined by volume, time, material balances and product yield. These calculations are based on the results obtained during process development. The titer and yield of functional, recoverable product determines the plant size. Optimal volumetric ¬≠productivity [g/(liter reactor volume * day)] is of utmost importance. The main difference between fed batch and perfusion culture is that in the fed batch, a centrifuge is required for cell removal, whereas in perfusion culture, cell removal is performed by dead end filtration. This is possible because the majority of the cells are immobilised on the microcarriers, thus minimizing the burden on the clarification unit‚Ķ


Monoclonal antibodies and recombinant proteins have increased in importance and gained success as therapeutic agents in treating various diseases. Biomanufacturing of such a biopharmaceutical product by cell culture follows a main route. Upstream processing is strictly biology-driven, while on the other hand, purification is engineering driven. Fermentation is setting the pace. To some extent, that pace is a result of recent advances in cell culture, greatly increasing the densities of cells along with cell-related contaminants…


The ‚ÄúLean‚ÄĚ manufacturing process management methodology is derived largely from Toyota Motor Corporation‚Äôs 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‚ÄĒalso known as ‚ÄúLean Thinking‚ÄĚ‚ÄĒhas 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‚Ķ


The biologics market, although difficult to estimate, is currently thought to be in excess of $20 billion. In recent years, the growth in the novel therapeutics market has continued to exceed all but the most optimistic of expectations. The number of products in early stage trials may already be over 1,000, with an estimated 40 or so additional products in the process of finally being released to the market. The biologics market is led by relatively few ‚Äúblockbuster‚ÄĚ drugs, but the breadth of novel products continues to expand. This has resulted in exciting times for clinicians but has resulted in concern related to the bottleneck of production capacities for these drugs, as well as the pressure from healthcare agencies to reduce the cost of goods‚Ķ

Baculovirus Expression Technology Biologics Production

Biopharmaceutical manufacturers are constantly seeking new ways to lower production costs, while simultaneously increasing cost effectiveness without sacrificing quality. The U.S. biotech industry has grown from $8 billion in 1992 to $30 billion in 2002. As productivity in biopharmaceutical manufacturing has increased, pressures to contain costs have mounted in the healthcare industry, coupled with increased demands by investors, which results in increased cost containment pressures on the industry as a whole. Some biotechnology products need to be produced in large quantities (hundreds of kilograms per year) to meet both current and expected demand. This requires significant manufacturing capacity, and makes the types of incremental process improvements commonly sought in chemical pharmaceutical processing an attractive proposition for biopharmaceutical manufacturing…