biopharma Corner

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the March 2010 edition from Munters and NETZSCH.

Recent developments demonstrate the importance of biologicals, which usually are delivered through injections, for the drug industry?s future. To find out about the process of manufacturing prefilled syringes, and to learn about innovations in filling lines, Equipment and Processing Report talked to Thomas Otto, managing director of Vetter.

The US Food and Drug Administration recently published guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used to manufacture viral vaccines for human use.

A UK consortium completed pilot runs of a pharmaceutical-safety program that uses electronic tracking and authentication to ensure the safety of drugs in the supply chain.

The Pharmaceutical Research and Manufacturers of America, along with eight other pharmaceutical, business, and trade organizations, are calling on Russian authorities to consider policy changes concerning clinical-trial regulation and intellectual property.

The World Health Organization released new guidelines this week for the treatment of malaria and the first-ever guidelines on procuring safe and efficacious antimalarial drugs.

Exelixis And XenoPort Announce Job Cuts; GSK Dedicates India Facility; And More.

Camfil Farr APC Accela Form - ASKING THE RIGHT QUESTIONS ABOUT CARTRIDGE DUST COLLECTION

FETTE Accela Form - Maximize Tablet Press Productivity

FDA Published The International Conference on Harmonization S9 Guideline; ISPE Released A New Good Practice Guide On Manufacturing Execution Systems.

Continuous manufacturing could bring the pharmaceutical industry advantages such as improved product quality, easy scale-up, flexibility, and short cycle times. But how can a company switch from batch to continuous manufacturing?

Interphex 2010 Exhibitor Booth Invitations. You are invited to visit the following company booths at Interphex 2010, Apr. 20-22, in New York City.

EtQ Accela Form - Managing Your Risk Has Its Rewards: No Nasty Surprises, for Instance

In this paper, we will examine a real-world example of how using a risk assessment model in a quality management system can identify critical adverse events, mitigate the risk, and prevent re-occurrence of these events.

Top pharmaceutical and biotech companies will witness a major slow down in sales growth between 2008 and 2014, according to business analysts Datamonitor.

Top pharmaceutical and biotech companies should expect a major slowdown in sales growth between 2008 and 2014, according to business analysts Datamonitor.

Last week, the US Food and Drug Administration and the National Institutes of Health unveiled plans to establish a Joint Leadership Council to address important public-health issues.

Merck KGaA has agreed to acquire Millipore for EUR 5.3 billion ($7.2 billion).

The US Food and Drug Administration and the European Medicines Agency are implementing a streamlined process to help regulators better identify and share information regarding orphan-drug and biologic products.

Astellas Pharma Makes Bid for OSI Pharmaceuticals; Ringo Retiring From Pfizer; And More.

At last month's Informex, exhibitors announced expansions and new partnerships relating to contract manufacturing of active pharmaceuticals and intermediates and fine-chemicals supply.

Strategic rather than tactical considerations are driving biopharmaceutical outsourcing.

Following its $68-billion acquisition of Wyeth, Pfizer is integrating its manufacturing and outsourcing activities (Podcast).

METTLER TOLEDO?s new LiquiPhysics™ Excellence range of density meters and refractometers offer reliable measurement of density, specific gravity, refractive index and Brix, HFCS, alcohol concentrations and API degrees/gravity.

Nigel Darby, vice-president of biotechnologies at GE Healthcare Life Sciences and speaker at the Drug, Chemical, and Associated Technologies Association (DCAT) upcoming educational program on biologics, offers insight into the current and future state of upstream and downstream processing of biologics.

Could a collaborative approach involving both public and private parties offer a solution to Europe's lack of innovation?

A new kind of gastro-retentive dosage form for drugs with poor aqueous solubility was developed and evaluated, with the aim of achieving gastro-retention.

Compliance Accela Form - Principals of Viral Clearance Study Design and Performance

Moisture-activated drying granulation is a simple and effective process for particle size enlargement.

Last year, a member of the PTE editorial team attended the 2nd Annual Lyophilisation Conference in London (UK).

Although efforts have been made to improve solubility, many poorly soluble drugs still reach the market. Peter Nielsen discusses new developments in solubilisation technology, which could help those companies seeking to reinvigorate marketed products.

A round up of some of the news and trends from across the globe.

The most important consideration when choosing a freeze dryer is to ensure the system is fit for both today's applications and future needs.

Pharmaceutical Technology Europe discusses some of the latest challenges and innovations in pharmaceutical lyophilization.

Viral clearance studies are one of the three main contributors toward achieving assurance that an acceptable level of viral safety has been achieved for a product. Manufacturers need to justify the level of clearance achieved for each individual virus tested to the regulatory authorities. This paper outlines several key elements that need to be considered during the design and performance of these studies.

HPLC systems represent the latest development in liquid chromatography instrumentation.

Freeze drying is widely used in pharmaceuticals to improve the long-term storage stability of labile drugs.

Pharmaceutical Technology Europe spoke with experts about the developments that have shaped the nanotechnology industry today and the benefits that this technology has to offer the pharmaceutical industry, which remain largely untapped.

Compliance Accela Form - Principals of Viral Clearance Study Design and Performance

The University of California, San Francisco (CA, USA; UCSF) has signed an agreement with Genentech with the aim of discovering and developing drug candidates for neurodegenerative diseases.

Eli Lilly, Merck Sharp & Dohme and Pfizer have joined together to form the Asian Cancer Research Group (ACRG), a not-for-profit company aimed at accelerating research and improving treatment for patients affected with the most commonly diagnosed cancers in Asia.

A significant increase in the recruitment of contract staff is expected during the next 12 months in the UK biotechnology sector, according to a survey conducted by SRG, which provides personnel to various science-based sectors.

A significant increase in the recruitment of contract staff is expected during the next 12 months in the UK biotechnology sector, according to a survey conducted by SRG.

FDA issues data on drug-induced liver injuries and serious skin reactions; IPEC Federation Week starts in France.

Merck To Eliminate 15,000 jobs; Tauzin Stepping Down At PhRMA; And More.

Eli Lilly, Merck Sharp & Dohme, and Pfizer form the Asian Cancer Research Group, a nonprofit aimed at accelerating research and improving treatment for patients affected with the most commonly diagnosed cancers in Asia.

Arnesto Segredo of Miami, Florida, was sentenced to 70 months in prison for conspiring to divert prescription drugs.

Using Cao and Spotfire software, Dana-Farber's CVC developed a first-of-its-kind analysis approach to rapidly extract complex data specifically for cancer vaccines from the major clinical trial repository.

Liquids are used in a wide variety of industries, either during manufacture or as end-products in themselves. Whatever the end product, quality control of liquids is crucial to many industries.

Copley Revised Accela Form - Assessing dry powder inhalers

Synomics Accela Form - Transparency Paradigm: selecting a CRO for the Endocrine Program

The European Medicines Agency (EMA) and the Swiss Agency for Therapeutic Products, Swissmedic, have agreed to exchange information about the authorization and safety of H1N1 pandemic medicines.

Method Transfer of Loratadine from HPLC to UPLC using the ACQUITY UPLC H-Class System - Waters Whitepaper

Waters Accela Form - Easy Method Transfer from HPLC to UPLC

Transparency Paradigm: selecting a CRO for the Endocrine Program - Synomics Whitepaper

Simplifying Qualitative, Quantitative Analysis in Discovery DMPK - Waters Whitepaper

A joint investment of approximately 28 million Euros for seven projects hopes to bring personalized medicine closer to reality by developing ways of delivering drugs to specific disease sites within the human body.

Waters Accela Form - Simplifying Qualitative, Quantitative Analysis in Discovery DMPK

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 Society for Chemical Manufacturers and Affiliates offered its support for a Senate proposal to extend to 2015 current chemical-security standards, the Chemical Facility Anti-Terrorism Standards, which are set to expire this year.

Abbott Completes Acquisition Of Solvay; Merck Names President of Consumer Healthcare; And More.

Pall Accela Form - Re-Use of Sterilizing-Grade Filters

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

Summary report which discusses items of consideration and risks associated with the re-use of sterilizing-grade filters.

Re-Use of Sterilizing-Grade Filters - Pall Whitepaper

A joint investment of approximately 28 million Euros ($38 million) for seven projects may bring personalized medicine closer to reality by developing ways to deliver drugs to specific disease sites within the body.

The European Medicines Agency and the Swiss Agency for Therapeutic Products, Swissmedic, have agreed to exchange information about the authorization and safety of H1N1 pandemic medicines.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the February 2010 edition from ABB and David Round.

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?

Pharmaceutical manufacturers that launch ePedigree and serialization initiatives today will improve their competitive positions in the short and long terms.

Following its $68-billion acquisition of Wyeth, Pfizer is integrating its manufacturing and outsourcing activities (Podcast).

Figures published by the European Medicines Agency (EMA) relating to centralized procedure activities for human medicines show a significant increase in the number of positive opinions made between 2007 and 2009; however, the majority of approvals are for generic products.

GlaxoSmithKline (GSK) has launched a standalone unit that will specialize in the R&D and commercialization of medicines for rare diseases.

Personalized medicine is still a nascent area for the pharmaceutical company, but several large pharmaceutical companies recently reported on developments in this area.

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

GSK Chief Executive Andrew Witty outlined the company's strategic priorities for 2010, which include further diversification into emerging markets, consumer healthcare, and vaccines.

EMA statistics highlighting centralized-procedure activities for human medicines show a significant increase in positive opinions made between 2007 and 2009.

Margaret Hamburg, commissioner of the US Food and Drug Administration, unveiled a new program to improve the efficiency of import inspections.

VaxGen Shareholders Reject OXiGENE Merger; Roche Creates Research Hub In Singapore; And More.

GSK launched a stand-alone unit that will specialize in the R&D and commercialization of medicines for rare diseases.

Personalized medicine is still a nascent area for pharmaceutical companies, but several large companies recently reported developments in this area.

Due to reorganisation of stock levels, a pharmaceutical manufacturer is offering stainless steel vessels and stock of unused engineering spares to the process industry for auction.

An easy to handle non-consumable photometric linearity Certified Reference Material (CRM) set has been introduced by Starna Scientific which uses propyl parabenz in methanol to qualify photometric linearity in UV diode array based HPLC systems.

An easy to handle non-consumable photometric linearity Certified Reference Material (CRM) set has been introduced by Starna Scientific which uses propyl parabenz in methanol to qualify photometric linearity in UV diode array based HPLC systems.

Less than a week after president Obama proposed a spending freeze on non-security related federal programs, the FDA released its fiscal year 2011 budget request, calling for a 23% increase.

AstraZeneca plans to undertake further restructuring in its R&D operations, resulting in the elimination of 3500 jobs.

The Pharma Congress Production & Technology has been Germany's leading convention in the pharma environment for 11 years, combining high-class special subject matter conferences, an adjacent exhibition and directly connected hotel accommodation. Last year, nearly 400 delegates, exhibitors and visitors attended.

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.

A highly functioning New Product Planning (NPP) group is a company's first line of defence against losses caused by products that fail to reach the market, according to research and consulting firm Best Practices LLC.

Capsules that can release their contents at a selected temperature have been developed by researchers in France, and could lead to the development of therapeutic agents that are applied to the skin and triggered locally by rubbing.

Less than a week after president Obama proposed a spending freeze on nonsecurity-related federal programs, the US Food and Drug Administration released its fiscal year 2011 budget request, calling for a 23% increase.

The US Food and Drug Administration issued a draft guidance for industry, Assessment of Abuse Potential of Drugs, in late January.

AstraZeneca announced this week that it plans to undertake further restructuring in its research and development operations, resulting in the elimination of 3500 jobs.

Pfizer's first updated pipeline since its acquisition of Wyeth includes fewer projects than before and is targeted to specific diseases.

Cephalon Buys Mepha; BASi's CEO Retires; and More.

FDA Releases Annual Guidance Agenda; OMB Urges Obama to Issue Revised Executive Order.

Hoping to prevent the deaths of eight million children over the next decade, Bill and Melinda Gates recently committed $10 billion for child-immunization programs in the world's poorest countries.

Bulk Inspection of Tablets: Assuring Product Quality at Manufacturing and Packaging - Symetix Whitepaper

The rising importance of generic drugs, evolving requirements in the ever-more global supply chain, and supplier-management strategies in biologics manufacturing are some key topics to be addressed next month during DCAT Week.

Symetix Accela Form - Bulk Inspection of Tablets: Assuring Product Quality at Manufacturing and Packaging