Canada’s lead in biotechnology, and biotech’s rising influence, is providing a “second chance” at establishing a leading role in the global pharmaceutical industry. Half of all the new drugs approved by FDA are biologics. Why does that equate to a “second chance”? Well, with the skills, knowledge and physical manufacturing processes so completely different from the chemical synthesis of drug manufacture, the global pharma industry is “re-tooling” both its people and its facilities. Canada has the opportunity to leverage its leading biotech position to propel the biopharmaceutical industry forward in the changing landscape…
Category: <span>Manufacturing</span>
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…
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…
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…
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…
Single-use, disposable components offer many advantages in the manufacturing of biologics. They are clean and ready to use when supplied, which obviates the need for sterilization and decreases the requirement for services such as water for irrigation (WFI) systems and steam generators. Disposable components are not used for subsequent operations, eliminating the chance of cross contamination between process runs. Long lead times for equipment installation can be avoided because the need for stainless steel equipment is reduced or eliminated. Systems are less complex, therefore engineering requirements are also reduced. There is no need for clean-in-place (CIP) or steam-in-place (SIP) operations, along with the associated piping, valves, controls, or pressure rating of vessels. Moreover, the use of disposable components reduces the complexity of validation…
Singapore’s vision is to become a global hub for the biomedical sciences (BMS) with world-class capabilities ranging from basic and clinical research to manufacturing and healthcare delivery. This vision encompasses pharmaceuticals, biotechnology, medical technology, and healthcare services. Singapore’s BMS initiative was launched in June 2000 with the goal of developing the industry into a key pillar of Singapore’s economy. It is overseen by a Ministerial Committee chaired by Deputy Prime Minister Dr. Tony Tan and implemented by an executive committee led by Mr. Philip Yeo, who is chairman of the Agency for Science, Technology, and Research (A*STAR) and co-chairman of Singapore’s Economic Development Board (EDB)…
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…