Erik Greb

Cost-effective energy solutions are not only an important part of facility design and operation, but they are also an integral part of a company’s sustainability initiatives. Renewable energy sources can improve a company’s environmental profile and its bottom line. The choice of a particular energy source depends on the capital costs of implementing alternative power systems, the energy source’s compatibility with existing systems, and other operational issues. 

Last month, NewAge Industries, a manufacturer of plastic molding and fittings for the pharmaceutical and biopharmaceutical industries, completed a solar-energy project at its facility in Southampton, Pennsylvania. The company installed 4082 solar panels on its roof in an array that is designed to generate 1 MW of electricity annually, which is roughly half the amount of power that the company uses each year. The solar panels cover about three-quarters of the company’s 244,000-ft 

roof, making it one of the largest solar installations in the state. 

The total cost of the solar-power system was $4.2 million. The state of Pennsylvania gave NewAge Industries a $1-million grant for the project, and the federal government contributed $1.2 million. As a result, the total cost to the company will be roughly $2 million, and the company expects to get a return on its investment in around six years. NewAge Industries predicts that the solar panels will have a service life of 20 years without additional labor costs. 

Environmental considerations were one reason that the company decided to install the solar-panel array. “I think it’s the right thing to do for the planet,” said Ken Baker, the CEO of NewAge Industries. The solar array generates power to run the extruders, injection-molding machines, motors, and chillers that the company uses to make its products. The solar array will cut the company’s reliance on the local utility company by about half. By generating power, the company estimates that the solar panels will yield a positive cash flow of between $300,000 and $400,000 per year. A system of inverters and switch gear ensures a consistent flow of power to the facility. The system first looks to the solar array to meet the facility’s demand for power. If the solar array isn’t generating enough power, the system automatically supplements the power supply through the municipal power grid. 

The company considered other renewable energy sources, such as wind, but decided that they would be impractical, and Baker began thinking about solar energy several years ago. To learn more about the technology, he attended seminars at the Solar Power 2008 trade show in San Diego, California. During the trade show, Baker visited various vendors of solar arrays to gain a firsthand look at the technology. To take advantage of federal and state grants in sustainable energy as a way to finance part of the project, NewAge Industries hired Keith Peltzman, CEO of Independence Solar, a solar-power consulting company, to advise the company about financing options and the project’s predicted return on investment. 

The vendor-selection process started with a pool of six vendors that eventually was narrowed down to one company, Borrego Solar, a privately held solar-power contractor. Several factors played a role in the company’s decision, such as the company’s financial strength and 31 years of experience in solar power. In addition, NewAge asked all potential vendors technical questions that Peltzman had developed, and Borrego’s employees, which included solar engineers, had an exceptional amount of knowledge.  

Baker wanted to work with US-based companies, parts, and labor to complete the solar-power project to help keep jobs in the US—and because of the state and federal funding that he was receiving. This criterion helped Borrego, which is headquartered in California, win the NewAge contract. Baker purchased American-made solar panels from Oregon-based SolarWorld, even though he could have bought Chinese-made panels for $150,000 less. California-based SunLink provided the racking system, and Colorado-based Advanced Energy supplied the electrical inverters. 

But before the solar-array project could begin, NewAge Industries had to determine whether the facility’s roof could bear the weight of the panels, which totals about 98 tons. After hiring a structural engineer to examine the question, the company learned that about 60,000 ft 

 of its standing-seam roof could not handle the weight. Rather than reinforcing the roof’s superstructure, the company chose to use the larger part of the roof that could bear the panels. 

The company also had to assess its electrical transformer. NewAge Industries receives incoming electricity at 33,000 volts, and its transformer adjusts the voltage according to the company’s changing demand for power. The utility firm PECO asked the company to change its transformer to ensure the safety of PECO employees who would work on the line in the future. 

Baker emphasizes that he was not alone in making sure that the solar-array project went smoothly. NewAge’s purchasing and accounting groups helped hammer out the terms and conditions of the contract with Borrego. The company’s engineering and plant-maintenance teams also worked with the consultants to ensure that the installation is sound. All of the company’s workers have an additional stake in the project’s success. Employees own 30% of NewAge Industries and 30% of the solar array. Thus, employees receive a share of the company’s profits, and they will benefit when the solar array generates revenue. 

NewAge Industries had already been embracing sustainability initiatives before it began considering solar power. One of the company’s first projects was to reduce the amount of energy it used. An early initiative involved changing the lighting in the warehouse and manufacturing areas. By switching from mercury-vapor to T5 fluorescent lights, the company reduced its energy consumption by one-third. Later, the company replaced its propane trucks with cleaner electric trucks, which the solar array will now be able to charge. 

In addition, the company recently began installing high-efficiency motors in its equipment and upgrading its air-conditioning units. During the ribbon-cutting ceremony, contractors were installing energy-efficient windows to improve insulation and reduce power consumption. 

Installing the solar panels has not ended the company’s interest in alternative power sources. The site’s next project might involve powering some air-conditioning and heating units with geothermal energy, says Baker, thereby offering another way for the company to improve its environmental footprint. 

Articles

New Age Industries, a manufacturer of plastic molding and fittings for the pharmaceutical and biopharmaceutical industries, implements a solar-energy project at its Pennsylvania facility.

Sustainability at Work: Solar Energy

RUSNANO, a corporation established by the Russian government to foster the development of nanotechnology, has entered into a project to manufacture targeted-delivery nanodrugs to treat malignant neoplasms. The project’s total budget is 3.9 billion rubles ($130 million), of which RUSNANO will invest 1.299 billion rubles ($43 million).

The N.N. Blokhin Cancer Research Center of the Russian Academy of Medical Sciences is developing the targeted-delivery anticancer drugs. Pharmaceutical company Medsintez (Novouralsk, Russia) is also investing in the project and its manufacturing facilities will be the main production sites for the nanodrugs.

The project’s goal is to establish fully operating production facilities that manufacture effective and affordable anticancer drugs that use targeted-delivery systems such as liposomes, immunoliposomes and monoclonal antibodies. Production of immunoliposomes, monoclonal antibodies and liposomes based on doxorubicin, lizomustin, tsifelin, aranoz and bacteriochlorin is scheduled to begin in 2013 or 2014.

“Production of highly effective anticancer drugs in Russia will lower death rates from cancer among all population groups; it will increase the average lifespan and improve the quality of life for those who are ill,” said Olga Shpichko, Managing Director of RUSNANO, in a press 

. “Lower prices will not only improve accessibility of the drugs, but also allow the government to increase the amount of drugs it purchases for target programs without changing the budget.” 

Liposomal preparations are made of one or several layers of phospholipids that contain an active drug stimulant and an aqueous phase. Like passive targeted-delivery systems, liposomes are released from the bloodstream into malignant tumor tissue. 

Immunoliposomes combine passive targeted delivery with an active system. Antibodies fixed to their surface areas recognize tumor-specific molecular markers. One class of nanopreparations, monoclonal antibodies, uses active targeted delivery to destroy malignant cells.

In related news, Anatoly Chubais, RUSNANO’s Chief Executive Officer and Vladimir Uiba, Head of the Russian Federal Medical–Biological Agency (FMBA), agreed to work jointly to ensure the safe production and application of nanotechnology and nanomaterials. RUSNANO and FMBA will collaborate to protect Russians’ health during the research, development, production, consumption and disposal of products created with nanomaterials and nanotechnology. 

Under the agreement, RUSNANO and FMBA will establish technical and organizational measures and propose laws to ensure the safe production and use of nanomaterials and nanotechnology. The parties also will introduce nanobiotechnology for applied medical and pharmacological uses, create new types of drugs for socially significant and job-related illnesses, and devise effective means for detoxification and individual protection. 

RUSNANO, a corporation established by the Russian government to foster the development of nanotechnology, has entered into a project to manufacture targeted-delivery nanodrugs to treat malignant neoplasms.

Russian groups agree to produce anticancer nanodrugs

Rising titers in biopharmaceutical processes have enabled companies to produce highly concentrated liquid drugs. As concentrations have increased, fill volumes have decreased. The lower limit of a dose has dropped from 10 mL to 0.1 mL, and even smaller volumes are needed sometimes. Drugmakers have many incentives to avoid overfilling their containers, including the scarcity, and correspondingly high cost, of certain cells and ingredients. These concerns highlight the need for techniques that can fill small volumes of product with great accuracy. Many strategies are available to the industry, but which one works best?  

Bosch Packaging Technology studied the accuracy of various fill techniques and concluded that positive displacement remains the most accurate, according to Jeff Jackson, the company’s North American pharmaceutical sales director. A positive-displacement pump traps a given amount of fluid and forces it into a discharge pipe. Piston pumps, diaphragm pumps, and peristaltic pumps are different types of positive-displacement pumps, which are less sensitive to a product’s viscosity than other pumps.  

The traditional method of filling is with a piston pump that incorporates an O-ring seal. “The injectable pharmaceutical requirements for clean, accurate filling changed this design to a lapped-piston design that has a piston-to-cylinder clearance of one-hundred-thousandth of an inch without an O-ring. This has been the normal method of parenteral filling for several decades,” says Jack Lysfjord, principal consultant for Lysfjord Consulting. Though accurate, these devices also are delicate. “If you drop it just slightly or damage the piston, they won’t work anymore.” They’re also expensive.  

Rolling-diaphragm pumps, which were introduced later, do not exhibit the slight leakage that lapped piston pumps do. These pumps also reduce the shear effect on biological products and proteins, compared with piston pumps. They also equal the accuracy of the lapped piston pump. The rolling-diaphragm pump is one of the most accurate pumping systems available, says Jackson.  

A peristaltic pump, which typically is used in clinical applications, incorporates a rotating roller or series of rollers. An operator inserts flexible tubing into the rollers, connects it to the nozzle, and feeds product into it. The rollers compress the flexible tubing and force the liquid out the discharge, thus dispensing the desired volume. Peristaltic pumps have not performed as well as other types, but their accuracy has been improving as new designs emerge. “I would say their accuracy is approaching that of piston pumps,” says Jackson.  

Other filling techniques are less common, but still used for certain applications. Time-pressure filling, for example, uses air, nitrogen, or gravity to create a slight overpressure that pushes the product through an orifice. This filling method has fewer parts than other kinds, but the simplicity of design has its tradeoffs. Time-pressure technology is sensitive to product characteristics such as viscosity, says Jackson. The accuracy of time-pressure filling varies depending on fill volume. At low volumes, time-pressure filling is not as accurate as piston pumps are.  

In optical filling machines such as Millipore’s (Billerica, MA) Acerta system, sensors trained on the tubing trigger a valve to shut when product reaches the desired height or fill volume. Optical filling is about as accurate as time-pressure filling, according to Jackson.  

In the fill-by-weight technique, an empty vial is weighed on a scale. Next, a valve is opened to begin the fill. The valve must be closed in time so that the last drop of product does not overfill the vial. The accuracy of this technique varies, says Jackson. The weight keeps changing during the fill, so the system must stop filling, let the product settle, then read the weight to get an accurate measurement. This method is impractical for filling commercial quantities, so a company might choose to weigh one vial and use it as a guide for the others. “If you’re doing it at production speeds, fill-by-weight is probably the least accurate of any of the techniques,” says Jackson. On the other hand, the technique provides data about every container filled and allows underfilled units to be rejected.  

The mass-flow technique uses a sensor built around the product dosing tube. As product flows through the tube, the sensor measures its fluid mass. Mass flow is growing in popularity in the pharmaceutical industry because the accuracy of the flowmeters has improved. “It’s pretty accurate on big fill volumes, it’s not as accurate on small fill volumes,” explains Jackson. In addition, the flowmeter must be cleaned and sterilized on the filling machine because it’s part of the fluid path.  

Each filling technology is susceptible to certain product characteristics that can affect its accuracy or performance. “From my perspective, no one filling technique does everything, although the rolling-diaphragm pump is one of the better ones,” says Jackson. Current filling technology can accurately fill common dose volumes. Bosch has successfully filled 0.03-mL volumes accurately with rolling-diaphragm, piston, peristaltic, and time-pressure pumps. The company controlled fills to fractions of a drop. Drugmakers can rest assured. Apparently, it will take even higher titers and rarer products to challenge the accuracy of the filling techniques available to the industry. 

Drugmakers have many incentives to avoid overfilling their containers, including the scarcity, and correspondingly high cost, of certain cells and ingredients. These concerns highlight the need for techniques that can fill small volumes of product with great accuracy. Many strategies are available to the industry, but which one works best?

Turn Down the Fill Volume

The FDA has unveiled a new program to improve the efficiency of import inspections. The Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT) information-technology system allows border inspectors to reliably monitor products at the port of entry and to focus inspections on shipments that pose the greatest risk.

 to the Center for Strategic and International Studies, Margaret Hamburg, Commissioner of the FDA, explained that PREDICT uses various criteria to rank import shipments according to risk. The system evaluates whether a product is intrinsically risky and considers data obtained during previous examinations of shippers and producers. The agency can add information about factors such as floods, hot weather, or market conditions that raise a particular shipment’s risk of being spoiled or shoddy. The information is assembled and converted to a risk score for each shipment and investigators will check the riskiest items first. 

The PREDICT system automatically flags potentially risky shipments and gives low risk scores to innocuous materials, which can then be cleared rapidly through FDA inspection. According to Hamburg, the system will allow FDA inspectors to devote their attention to high-risk items. Carefully labeled products with good histories should experience only brief delays before entering the country. 

The new system will help the FDA deploy its resources strategically and cope with an expanding mandate. Investigators “will still be checking only a small percentage of all import shipments,” said Hamburg in the speech, “but they’ll be using better intelligence to decide which shipments to check.” FDA piloted PREDICT in Los Angeles and is now installing it in New York. The system is expected to be running around the country by the end of spring 2010. 

PREDICT is one part of an ongoing overhaul of the agency’s approach to ensuring drug safety. “We are moving from a system that places most of the regulatory burden on the FDA’s modest inspection force to one that creates greater oversight at points further back along the production chain,” said Hamburg.  She also added that the challenges of globalization require international cooperation to establish a “global safety net”. 

In addition, the FDA seeks to hold importing companies responsible for their supply chain. Hamburg said: “Companies must be able to effectively demonstrate that safety, quality, and compliance with international and US standards are built into every component of every product and every step of the production process." 

The FDA has unveiled a new program to improve the efficiency of import inspections.

FDA strengthens import inspections

 since its acquisition of Wyeth includes fewer projects than before and is targeted to specific diseases; after the acquisition, the companies’ combined pipeline had 600 projects, but the number has been reduced to about 500. The new development pipeline, which includes both companies’ projects, includes 133 programs from Phase I through registration.

Approximately 70% of Pfizer’s research projects and 75% of the late-stage portfolio are focused on six “Invest to Win” areas of research, which include oncology, pain, inflammation, Alzheimer’s disease, psychoses and diabetes. 

The updated pipeline also emphasizes vaccines and biologics, and this focus is consistent with Pfizer’s goal of becoming a leading biopharmaceutical manufacturer by 2015. The number of vaccines in the company’s pipeline has increased from one to six since the last pipeline update in March 2009. Pfizer now has 27 biologics in development, an increase from the 16 in development in March 2009.

“This pipeline of investigational medicines represents the strong future of Pfizer,” Martin Mackay, President of Pfizer’s PharmaTherapeutics R&D, said in a press release. “Since the closing of the Wyeth transaction late last year, we have made strategic decisions about our research and development resources, global footprint, and high-priority projects. Our focus now turns to delivery of these health solutions for patients around the world.”

Pfizer’s updated pipeline includes the following projects: 

30 oncology compounds such as PF-02341066 for the treatment of nonsmall cell lung cancer and axitinib for lung, gastrointestinal, thyroid, and breast cancer and renal-cell carcinoma

10 compounds to treat Alzheimer’s disease, including Latrepirdine (Dimebon), a collaboration between Pfizer and Medivation (San Francisco), and bapineuzumab, a collaboration between Pfizer and Janssen (Titusville, NJ) 

Eight compounds to treat pain, including tanezumab, an injectable biotherapeutic compound that targets nerve-growth factor

11 compounds to treat inflammation, including tasocitinib (CP-690,550) for the treatment of rheumatoid arthritis

Six vaccines and 27 biologics, including Prevnar 13, a vaccine designed to prevent pneumococcal disease in infants and young children. 

Pfizer?s first updated pipeline since its acquisition of Wyeth includes fewer projects than before and is targeted to specific diseases; after the acquisition, the companies? combined pipeline had 600 projects, but the number has been reduced to about 500.

Pfizer streamlines and prioritizes pipeline

The World Health Organization’s (WHO) response to the H1N1 pandemic was not improperly influenced by the pharmaceutical industry, Keiji Fukuda, special adviser on pandemic influenza to the WHO’s Director General, explained at a 

 held by the Council of Europe to address concerns over the WHO’s reaction to the pandemic.

 rejected claims that vaccine producers had behaved inappropriately during the response to H1N1 influenza. The group said that vaccine manufacturers had responded to the requirements of public-health authorities and national governments.

Fukuda said that cooperation with various partners, including some from the private sector, is essential to the WHO's ability to address public-health challenges. He said that the organization uses various safeguards to manage real or perceived conflicts of interest among members of WHO advisory groups and expert committees. Fukuda noted that experts declare their financial and professional interests to the WHO as one safeguard. He stressed that WHO takes allegations of conflicts of interest seriously and expressed his confidence in the scientific validity of the body’s decision-making during the influenza pandemic. 

During his closing remarks, Fukuda said that the influenza pandemic was a “scientifically well-documented event in which the emergence and spread of a new influenza virus has caused an unusual epidemiological pattern of disease throughout the world.” The WHO did not declare a pandemic arbitrarily or for polemical purposes, he added. “The labeling of the pandemic as ‘fake’ is to ignore recent history and science and to trivialize the deaths of over 14,000 people and the many additional serious illnesses experienced by others,” he said. 

The WHO’s 2009 pandemic-preparedness plan was an updated version of its first such document, which the organization drafted in 1999. Stressing the effort the WHO put into the plan, Fukuda said that the plan included contributions from more than 135 public-health scientists from 48 countries. A request for public comments on the draft document yielded more than 600 replies. 

The WHO received its first reports of H1N1 in April 2009 and conducted laboratory testing on the virus. WHO did not announce the start of a pandemic until June 2009, after the virus had met its updated pandemic criteria. 

Acknowledging questions about the WHO’s performance, Fukuda said at a 

 held earlier this month that the organization would be conducting a self-review. He said that the WHO had acted under International Health Regulations, which call for an evaluation of how well the regulations have been implemented. “WHO will use this opportunity to begin an evaluation of its own performance,” Fukuda said. 

The World Health Organization?s (WHO) response to the H1N1 pandemic was not improperly influenced by the pharmaceutical industry, Keiji Fukuda, special adviser on pandemic influenza to the WHO?s Director General, explained at a hearing held by the Council of Europe to address concerns over the WHO?s reaction to the pandemic.