Pharmaceutical Processing articles from January 2007

Pharmaceutical Processing archives from January 2007

Meet the new boss, same as the old boss.(From the Editor)
January 1, 2007... Last year I attended a conference on pharmaceutical lean manufacturing techniques. Of all the speakers and presentations that I listened to one statement is still ringing in my ears. In his opening remarks the conference chairperson had this to...

Flexible mixing system mixing is designed for all tasks and viscosity ranges.(What's Hot)
January 1, 2007... The flexible and modular PARAVISC mixing system can process products across all normal viscosity ranges. By combining various individual components, the flexible modular design system can address the most diverse mixing requirements. This can...

Bag filter designed for high flow rate applications.(What's Hot)
January 1, 2007... The MAXILINE[TM] MBF HD Multi-Bag Filter Housing has been designed for cost sensitive, high flow rate liquid filtration applications. The unit features a rugged, hand wheel operated davit cover that provides dependable service in most demanding...

Freeze dryers are in compliance with cGMP, GAMP and 21 CFR part 11.(What's Hot)
January 1, 2007... Lyophil production systems fulfill the requirements of the pharmaceutical industry for reliable, validated production. Company can deliver both standard and customized plant configurations and make sure that individual process requirements are...

Pump head offers virtually pulsation-free cell transport.(What's Hot)
January 1, 2007... The Peripex pump head is constructed with a 6-roller planetary design for virtually pulsation-free transport of even the most sensitive cells. Besides variable speed control, Peripex pumps are provided with a multitude of functions for their...

Fully automatic vial washer offers compact size.(What's Hot)
January 1, 2007... The RW-500 vial washer can handle 1-100cc vials (glass or plastic) up to 100 vials per minute (vial dependent). The machine's compact design measures only 36" x 40" and is extremely efficient (WFI of less than 1 gpm). The unit is virtually...

Cell culture instrument uses a disposable, closed system.(What's Hot)
January 1, 2007... The AutovaxID is a fully automated, reusable instrument that employs a fully disposable, closed-system cell-growth chamber incorporating a hollow-fiber cell-growth cartridge. This unique bioreactor replaces conventional stainless steel, glass,...

Pharmaceutical industry faces one-two punch in 2007: the combination of a Democratic Congress and Republican White House will put the industry under increasing scrutiny.(DRUG PRICES & SAFETY REGULATION)(Cover story)
January 1, 2007... We expect 2007 to be an extraordinarily busy year for healthcare industries in Washington. Campaign promises, budget issues, and expiring statutes should dictate healthcare priorities for the 110th Congress. However, the dynamics of a...

Large pharmaceutical & biotechnology companies may feast on the small- and mid-cap biotechs in 2007: biotech companies may be easy pickings for big pharma this year.(INDUSTRY OUTLOOK 2007)
January 1, 2007... Our fearless prediction for biotechnology in 2007 is that more small- to mid-cap biotech companies will be acquired by either large pharmaceutical (pharma) or large biotech companies. We believe the recently announced acquisitions (Figure 1)...

Convergence of opportunities and interests in pharmaceuticals and biotechnology: recent trends point to an intersection of these two sectors as each refines its strategic focus.(INDUSTRY OUTLOOK 2007)
January 1, 2007... Historically, the business interests of pharmaceutical research/manufacturing companies have taken a different path than those of biotechnology companies, specialty pharmaceutical manufacturers, generic manufacturers and clinical research...

Expanding Phase IV trials and use of biomarkers for personalized medicine can help reduce drug risks can the industry and FDA ensure long-term drug safety?(INDUSTRY OUTLOOK 2007)
January 1, 2007... How do we get to that ideal of personalized medicine, "The right drug at the right time for the right patient"? And, while we're working on the "right" drug, let's look at drugs overall, and ask ourselves this immediate question: How can we...

Today's production management systems enable lean, demand-driven supply chains: evolving technologies force manufacturers to optimize their systems.(Solutions)
January 1, 2007... Life sciences industries are moving to global manufacturing utilizing both contract and internal production resources. In parallel, manufacturers are figuring out how to incorporate RFID technology for supply chain traceability and PAT...

Survey says software alone is not the answer to what ails pharmaceutical manufacturing performance: software systems not delivering the expected return on investment.(Solutions)
January 1, 2007... Outsourcing, off-shore competition, eroding profit margins, and demanding customers force pharmaceutical companies to optimize manufacturing performance or prepare to expire. Many are grasping for leaner, demand-based strategies in light of...

Double duty: integrated ERP software provides dual benefit: compliance with 21 CFR Part 11 can actually help improve profits.(Solutions)
January 1, 2007... For pharmaceutical manufacturers, there are many industry tools available to help them comply with the FDA's recordkeeping and lot-tracking requirements of 21 CFR Part 11. But perhaps one of the most overlooked applications is also one of the...

Are data standards on your radar screen? And will they affect your manufacturing processes?(Applications)
January 1, 2007... The importance of standards is a fundamental concept within the realm of manufacturing, since the ability to successfully and efficiently engineer and produce a consistent level of output depends on having operational systems that apply precise...

Laboratory metrics: beyond QA and risk-control, and into the world of marketing: good quality metrics ensure good products.(Applications)
January 1, 2007... Before a potentially lifesaving drug can be used to treat patients, it must be proven to be safe and effective to treat the illness for which it is intended. Drugs must be reviewed and approved by a regulatory agency set up for that purpose. In...

Intelligent sensor management systems: information for efficiency: these systems can offer higher productivity, less downtime, better operational safety, lower operational costs and improved profit margins.(Applications)
January 1, 2007... Maintenance and consumable costs are a self-fulfilling problem in that the very presence of the equipment and the fear of downtime justify high maintenance budgets. An intelligent sensor management system can alleviate this situation. The...

Finding the Middle ground in manufacturing through hybrid control systems.(Pharma IT)
January 1, 2007... The Life Sciences industry represents an ideal environment for deploying Hybrid Control Systems. After all the industry itself is a hybrid. Life Sciences (pharmaceutical and biopharmaceutical, in particular) is one of those few industries that...

INTERPHEX2007 Conference focuses on best practices and innovation.(INTERPHEX2007 UPDATE)
January 1, 2007... The INTERPHEX2007 Conference is designed to bring you up to speed quickly on the issues and technologies that are most critical to productivity improvement, and provide practical insights and techniques that you can implement now. Whether you...

FDA warns five firms to stop compounding anesthetic creams.(Industry News)
January 1, 2007... The FDA is warning five firms to stop compounding and distributing standardized versions of topical anesthetic creams, which are marketed for general distribution rather than responding to the unique medical needs of individual patients. Firms...

Mixer features effective non-rotating teflon seal.(Production/Manufacturing: Cool Technology)
January 1, 2007... The Clean Sweep mixer features a proprietary, effective, long-lasting elastomer backed Teflon, [R] seal The Clean Sweep--a non-rotating, sanitary mixer--has a Teflon diaphragm that provides secure sealing for almost any process. The material of...

Automatic inspection machines for ampules, cartridges, vials and bottles.(Production/Manufacturing: Cool Technology)
January 1, 2007... The VI series are high performance inspection machines for a wide range of parenteral products, liquid or lyophilized solutions or opaque suspensions. The unit features the inspection of cosmetic defects and particle inspection combined on one...

Dust-free milling system ideal for tablet production.(Production/Manufacturing: Cool Technology)
January 1, 2007... The Quadro Vac is an operator-friendly, sanitary pneumatic conveyor. Featuring simple, adjustable "air logic" controls, a rugged mechanism with auto-cycle and self-cleaning filter (backwash), the unit is ideal for processing environments. An...

Quick-clean centrifugal screener has cantilevered shaft.(Production/Manufacturing: Cool Technology)
January 1, 2007... The Centri-Sifter[R] centrifugal screener model "GO" features a cantilevered shaft with two, externally-mounted bearings between the screening chamber and motor drive, allowing all internals to slide freely from the shaft end for cleaning,...

Aseptic vial filling equipment gently fills injectables.(Production/Manufacturing: Cool Technology)
January 1, 2007... The FMB210 filler offers an aseptic filling process that combines the security of sterile containment and gentle peristaltic dispensing action to safely and accurately fill injectable products into vials. The company's filling technology...

Lab sized roller-style granulator achieves narrow particle size distribution.(Production/Manufacturing: Cool Technology)
January 1, 2007... The Model 6.5 Gran-U-Lizer can achieve grinding uniformity on a wide range of materials in both the lab/pilot and production environments. The 6.5 achieves a narrow particle size distribution, with few unwanted fines, on nearly all friable...

Alcan to invest $27.5 million in Shelbyville, Kentucky pharmaceutical packaging center.(Industry News)(Company overview)
January 1, 2007... Alcan will invest $27.5 million for an expansion project in its Pharma Center in Shelbyville, Kentucky. Alcan Packaging Shelbyville is a leading supplier and the only North American facility in the packaging industry dedicated to pharmaceutical...

FDA proposes rules overhaul to expand experimental drug availability.(Industry News)
January 1, 2007... The FDA recently proposed significant regulatory changes to make experimental drugs more widely and easily available to seriously ill patients with no other treatment options and to clarify the circumstances and the costs for which a...

GlaxoSmithKline to acquire Domantis.(Industry News)
January 1, 2007... GlaxoSmithKline plc recently announced that it has entered into an agreement to acquire Domantis Ltd, a leader in developing the next generation of antibody therapies, for $454 million in cash. Domantis, a privately owned company, will become...

Stantec's Dave DiProspero awarded ISPE Member of the Year Award.(Industry News)
January 1, 2007... The International Society of Pharmaceutical Engineers (ISPE) awarded Dave DiProspero, Principal at Stantec, the prestigious Max Seales Yonker Member of the Year Award at their Annual Meeting held November 5-8 in Orlando, Florida. Acknowledged...

Merck signs collaboration agreement with Idera.(Industry News)
January 1, 2007... Merck & Co., Inc. and Idera Pharmaceuticals recently announced that they have formed a broad collaboration to research, develop and commercialize Idera's Toll-like Receptor (TLR) agonists by incorporating them in therapeutic and prophylactic...

Clinical trial failures highlighted in GAO report.(Industry News)
January 1, 2007... A "systematic analysis" of why drugs fail during clinical testing could help curb the rising number of trial failures and prevent companies from repeating others' trial mistakes, the GAO suggests in a recent report, The Pink Sheet reports. ...

Impact of antidepressant black box juggled by Advisory Committee, FDA.(Industry News)
January 1, 2007... The addition of new, positive data on adult suicidality to antidepressant labeling could be an opportunity to offset the negative impact the "black box" warning on pediatric suicidality has had on antidepressant use, according to members of...

Action on Exforge.(NOTED)
January 1, 2007... Action on Exforge: Novartis has received tentative FDA approval for its combination hypertension treatment Exforge (amlodipine/valsartan), but cannot launch or promote the product until September 2007, following patent and exclusivity...

Lutter to fill Gottlieb's shoes.(NOTED)
January 1, 2007... Lutter to fill Gottlieb's shoes: FDA Associate Commissioner for Policy and Planning Randall Lutter has been appointed acting deputy commissioner for policy, the agency recently announced. Lutter will replace Deputy Commissioner for Medical &...

Merck board elects CEO chairman.(NOTED)
January 1, 2007... Merck board elects CEO chairman: Merck's board of directors has elected CEO Richard Clark as chairman, effective April 24, 2007. The board's executive committee, currently composed of directors Samuel Thier and Lawrence Bossidy, has been...