Manufacturing Articles

The ability of an instantaneous microbial detection system (IMD-A) to monitor microbial populations in environmental air was evaluated. The IMD-A results were compared with results from conventional environmental air monitoring methods. The comparisons were carried out in controlled microbial barrier test chambers and in cleanroom environments. Additionally, microbial populations in environmental air in an unclassified environment were evaluated using the IMD-A and the all-gas impingement (AGI) method coupled with ScanRDI. In 1-m3 and 150-m3 controlled-barrier test chamber studies the mean recoveries with the IMD-A were equal to or greater than the mean recoveries obtained with the Anderson air sampler at various concentrations. The mean microbial recoveries obtained using the AGI were higher, but in the same order of magnitude, as those recovered by IMD-A.

Some general managers may think they need only an accountant and an attorney to run a business, but if you have risen through the technical ranks, you know a lot more insight is required to successfully manage an API facility. Sure, accounting and legal services are two very important items in your toolbox. Both functions tend to operate in a conservative fashion and serve to mitigate or limit risk. However, businesses do not tend to grow without taking risks. General Patton was quoted as saying, "Take calculated risks. That is quite different from being rash."

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Hood, suit, faceplate, cover shoes, gloves: these are the necessary items of clothing when operating in A- and B-grade areas. The principal purpose of protective clothing is to minimize the risk of microbiological contamination caused by personnel. Thus, protective garments should not release fibers and must be able to contain particles produced and released by the body.

But how can we ensure that protective garments are not themselves vehicles of contamination? And how can we ensure that cleaning and sterilization processes are effective and do not alter the characteristics of the garments? We attempted to answer these questions, concentrating our attention mainly on glasses (in general, on individual protection devices usually referred to as masks).

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Transgenic milk production offers a cost-effective system for the manufacturing of large amounts of complex proteins. Specifically, commercialization is near for recombinant human antithrombin (rhAT) expressed in transgenic dairy goats. The product received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicine Agency.

This article reviews the reasons why transgenic milk is a cost-effective system. Also reviewed is the earlier research on targeting heterologous proteins to the mammary glands of many different animals. The final section describes the process by which goats express rhAT in their milk at approximately 2 g/L. The human AT purified from milk is structurally indistinguishable from human plasma–derived AT with the exception of carbohydrates. Clinical studies are ongoing on the prevention of deep-vein thrombosis.

Biopharmaceutical companies around the world use disposable processing equipment for numerous reasons. According to Barres's 3rd Annual Report and Survey on Biopharmaceutical Manufacturing,1 they are to minimize or improve, in order of importance, cross-contamination, cleaning, time-to-start, capital investment, production cycle, and assurance of sterility. The priority varies, of course, according to a drug company's business objectives. For example, vaccine manufacturers regard cleaning and sterility as the most important reasons for adopting this processing model. Contract manufacturing organizations (CMOs) use disposable technologies because they minimize the risks of cross-contamination. Biotechnology manufacturing firms view disposables as a way to reduce capital investment.

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As pharmaceutical product coding regulations change, and as the threat of counterfeiting increases, drug companies are looking for better methods of product identification. Coding and marking are keys to accurate, reliable product identification that can combat counterfeiting. The latest coding and marking technologies have the added benefits of helping to provide flexible coding methods, streamline production, improve productivity, reduce costs and increase profits.

Addressing the Challenges

New and updated regulations on drug product coding, driven by security issues and emerging technologies, have left pharmaceutical manufacturers, repackers, relabelers and distributors searching for cost-effective options to comply.

Drug companies, regulators, insurers, caregivers and patients face tremendous challenges due to the growth in drug counterfeiting and need better ways to protect the integrity of the healthcare delivery system, the drug products and patient safeguards.

Almost every day, we hear another story about the spread of avian flu and the possibility that it will lead to a pandemic rivaling the disaster of 1918. Responding to this growing fear, the president recently announced a $7.1 billion plan that would include purchase of 20 million doses of vaccine to protect against the current strain of avian flu. The plan also included incentives to develop new production methods, and protection against liability claims so that vaccine makers would add U.S.-based facilities. “If a pandemic strikes, our country must have a surge capacity in place that will allow us to bring a new vaccine online quickly and manufacture enough to immunize every American against the pandemic strain,” said the president. (For more on the White House’s strategy, see my From the Editor commentary on page 12.)

Four new inhaled-insulin therapies are following Exubera (insulin) down the drug pipeline, and each one of them may eventually enjoy a significant advantage over Pfizer's groundbreaking new delivery system. But for now, Pfizer has the only drug in its class. The new inhalation system, originally developed by Nektar Therapeutics of San Carlos, California, shows a similar insulin profile to subcutaneously injected insulin, and has proven popular with patients during clinical trials. Although the drug's price had not been set at press time, strong patient uptake is fairly well assured. In part because the world's largest pharmaceutical company will put its marketing muscle behind it. But also because pulmonary delivery could boost compliance among patients who resist treatment because they fear needles or hate injections.

IN BIOMANUFACTURING, EXPRESSION technology, an optimized process, and the required production capacity are all intertwined. The choice of a prolific expression technology and efforts expended to improve production processes can have a dramatic affect o­n the amount of capacity needed. After the push to build capacity in the past few years, contract biomanufacturers are now focusing o­n improving production efficiencies.

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Manufacturing and laboratory efficiency issues have direct effects o­n cash flow, balance sheet, product quality and customer satisfaction. Performance behind the competition—or ahead of it—can dramatically affect shareholder value. Therefore, in the face of ever-challenging profitability and revenue goals, pharmaceutical companies and contract manufacturers alike are striving to improve and enhance their manufacturing and laboratory efficiency. A solid understanding of manufacturing costs and performance metrics among world-class companies is the first step in evaluating a company’s own current practices.

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