Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Rita C. Peters

The Rostov-on-Don Medicines Quality Control Laboratory of the Federal Service on Surveillance in Healthcare (Roszdravnadzor) has attained ISO/IEC 17025:2005 accreditation for testing and calibration laboratories. The facility is the first official medicines control laboratory in Russia to have achieved internationally recognized ISO accreditation, according to a 

press release from the U.S. Pharmacopeial (USP) Convention

 The accreditation was awarded by ACLASS, an accrediting body based in Washington, D.C., for seven key analytical tests: high-performance liquid chromatography, dissolution, ultra-violet visible spectroscopy, thin-layer chromatography, Karl Fischer titration, pH, and limulus amebocyte lysate. 

 The accreditation certifies that the Rostov-on-Don laboratory is providing valid and trustworthy data to Roszdravnadzor, the Russian drug-monitoring agency, helping to ensure the distribution of good quality medicines. The USP, provided technical assistance to Roszdravnadzor through its Promoting the Quality of Medicines (PQM) program. Assistance included conducting an assessment of the Rostov-on-Don laboratory’s quality management system against ISO/IEC standards; providing ongoing monitoring of the laboratory’s progress toward accreditation; and hosting Roszdravnadzor staff at its US headquarters to observe how USP’s quality management system complies with ISO standards. This support occurred in several stages between September 2011 and October 2012.

 ISO/IEC 17025:2005 accreditation positions Rostov-on-Don as an international reference for labs working on quality control of pharmaceutical products. It extends the lab’s reach in supporting public health across Russia and the wider region. 

Articles

The Rostov-on-Don Medicines Quality Control Laboratory is the first official medicines control laboratory in Russia to have achieved internationally recognized ISO accreditation.

Russian Lab Achieves ISO Accreditation

When Galileo Galilei gained fame more than 350 years ago as a physicist, mathematician, and astronomer, his theories placed him ahead of other thinkers of the time. His contributions to observational astronomy in support of heliocentrism—that the Earth revolves around the sun—made him a controversial figure in his time.  

One of Galileo's observations, "By denying scientific principles, one may maintain any paradox," supported his belief in science-based studies and rings true for pharmaceutical and biopharmaceutical development and manufacturing today.  

True to Galileo's words, in this issue, we focus on what has become an overarching thrust to biopharmaceutical/pharmaceutical development and manufacturing, namely the application of a science- and risk-based approach under quality-by-design (QbD) principles. Process analytical technology (PAT) is key element of QbD for achieving process understanding, and we examine the advances in PAT as it applies to parenteral drug manufacturing. 

We also examine, in a roundtable of industry experts, the implementation, including the challenges, of process validation in line with the product lifecycle concept underlined in FDA guidance and ICH guidelines. 

Analytical testing and instrumentation, which underpins all development and manufacturing, is an integral part of achieving the desired product quality not only in a QbD paradigm but also for "traditional" development and manufacturing.   

In mid-March, analytical scientists from around the world will gather in Philadelphia for the Pittcon conference and exhibition, billed as the largest meeting for the analytical sciences.    

The program covers advances in analytical methods development, testing, and instrumentation using chromatography, spectroscopy, electrochemistry, microscopy, thermal analysis, and other techniques. Conference programs will detail novel applications of measurement science for pharmaceuticals, biomedicine, nanotechnology, and more. The editors of 

 will be in attendance, exploring the latest advances in analytical technology.  

In late January, I joined Advanstar Communications as editorial director for the Pharmaceutical Drug Development and Manufacturing Group. In that role, I oversee 

I am excited to work with the editorial team: Executive Editor Patricia Van Arnum, Managing Editor Susan Haigney, 

Editor and Scientific Editor Adeline Siew, Scientific Editor Amy Ritter, Manufacturing Editor Jennifer Markarian, and Community Editor Christopher Allen. 

Although new to these publications, I previously worked for a publication in the drug-discovery segment of the pharmaceutical industry.  I also have worked on publications addressing contamination control and controlled environments. 

I look forward to the challenge of providing readers with the research, technical insight, and expert analysis needed to advance formulation and drug delivery, API manufacturing, finished drug-product manufacturing, analytical testing, and regulatory compliance. 

 will continue to deliver peer-reviewed research and technical articles in print, as well as news, expert analysis, and interviews on 

 newsletters, deliver news and exclusive features directly to your desktop. In the coming months, we will be expanding our interactive features of podcasts, webcasts, polls, and exciting new media products. 

Interaction with our readers is of utmost importance. We welcome your comments, thoughts, suggestions, and editorial contributions. 

QbD paradigm advances process understanding in development and manufacturing.

Catching Up

Building on the recent announcement of the formation of a Dosage Form Solutions (DFS) business unit, Capsugel announced on March 1 that it has acquired Scotland-based Encap Drug Delivery.  Encap’s focus on liquid and semi-solid encapsulation-based product development, and clinical and commercial manufacturing for the pharmaceutical industry, complements Capsugel’s DFS business unit, the company reports in a 

Encap operates an FDA- and MHRA-inspected pharmaceutical product development and manufacturing site, is equipped to handle high potency active ingredients, and has established a clinical fast-track program that can speed the process from lab to clinic. Additionally, Encap’s proprietary targeted release technologies (DuoCap and ENCODE) and abuse deterrence technologies (Abusolve) will add to Capsugel’s offerings in these areas.

 “Encap’s capabilities and offerings align seamlessly with our DFS business unit, which is focused on lipid-based formulations and targeted release capsules,” says Guido Driesen, President & CEO of Capsugel.  “This acquisition will accelerate the growth of DFS and further strengthen our leadership position in liquid-filled formulations in hard capsules.”

Amit Patel, President of Capsugel DFS, adds, “The combination of DFS and Encap creates greater depth and breadth of our technology platforms, product development capabilities, and manufacturing infrastructure, which will collectively enhance our ability to improve our healthcare customers’ products in areas such as bioavailability, stability, dosing and delivery, and overall time-to-market.” 

Capsugel’s acquisition of Encap Drug Delivery expands its lipid expertise and adds an FDA-inspected commercial manufacturing facility.

Capsugel Acquires Encap Drug Delivery

Barring a last-minute deal by the US Congress to delay or end the threat of sequestration, a total of $85 billion in across-the-board U.S. government spending cuts will be triggered on March 1, threatening to slow scientific research, the development of innovative drugs and medical devices, and the ability of patients to get access to new therapies, reports 

How big an impact sequestration has on the life sciences will depend on whether action is eventually taken that spares the U.S. Food and Drug Administration and the National Institutes of Health from the cuts, and if not, how these agencies take steps to implement the cuts to their individual budgets, the statement reports.

The FDA is expected to lose $318 million in funding and cut hundreds of jobs to adjust to the lower funding level. For the NIH, sequestration would mean the loss of more than $1.6 billion in funding and reduce the number of grants it issues by more than 2,000, Burrill reports. 

“While the political parties remain divided over issues of what mix of spending cuts and taxes are needed to address the country’s budget problems, it appears no one wants to take responsibility for unpopular choices and so we end up with an ax, rather than a scalpel,” says G. Steven Burrill, CEO of Burrill & Company. “The unwillingness to make difficult decisions and reach compromise will harm innovation, weaken our economic strength, and delay patients’ access to new medicines.”

The evolving situation in Washington comes against a backdrop of weakened financing activity for the life sciences sector in February, a month in which activity fell dramatically from levels a year ago. Global venture financings for life sciences companies totaled $582 million in February, a 47% decline from the same period a year ago and the lowest monthly activity in two years. On the public financing side, total global financing transactions for life sciences companies in February reached an anemic $865 million, a 78% drop from the $3.9 billion for the same period a year ago. 

In addition to the sequestration drama, the threat of a government shut down looms, unless action is taken to address the current spending bill that is set to expire March 27. 

Mandatory cuts threaten to slow research and patient access to new therapies, Burrill & Company says.

Sequestration Threatens Life Sciences, Drug Development

The European Commission granted H. Lundbeck A/S marketing authorization for Selincro (nalmefene) for the reduction of alcohol consumption in adult patients with alcohol dependence, the company reports in a 

.  The approval of Selincro applies to all 27 European Union (EU) member states.

Selincro is a dual-acting opioid system modulator, and acts on the brain’s motivational system, which is dysregulated in patients with alcohol dependence. Selincro is thought to reduce the reinforcing effects of alcohol, and thereby reduces the urge to drink alcohol, the company reports. The drug has been shown to be effective in reducing alcohol consumption in patients with high drinking risk level. Patients treated with Selincro showed a 40% reduction in total alcohol consumption within the first month, and after six months the alcohol intake was reduced by approximately 60%. 

 Lundbeck will provide Selincro as part of a novel treatment concept that includes continuous psychosocial support focused on the reduction of alcohol consumption and treatment adherence. It has been developed for use on an as-needed basis, with one tablet taken each day when the patient feels a risk of drinking. 

 The marketing authorization of Selincro is based on the results of three pivotal, randomized, doubleblind, placebo-controlled trials that evaluated the efficacy and safety of Selincro in approximately 2,000 alcohol dependent patients.  

 Subject to the completion of pricing and reimbursement discussions, Lundbeck expects to launch Selincro in its first markets in mid-2013.

The European Commission has granted H. Lundbeck A/S marketing authorization for Selincro (nalmefene) for the reduction of alcohol consumption in adult patients with alcohol dependence.

European Commission Authorizes First Therapy for Alcohol Dependence

 defines a rare disease as one that affects fewer than 200,000.  There are nearly 7000 rare diseases affecting nearly 30 million-or nearly one in 10-Americans, according to the 

	The National Institutes of Health (NIH) reports that approximately 80% of rare diseases are genetic in origin; about half affect children. The challenges of facing a chronic, disabling, severe, or even life-threatening disease is compounded by difficulties in receiving an accurate diagnosis, and the lack of therapies to address the condition.

	For the past six years, the last day in February has been designated Rare Disease Day. First observed in Europe in 2008 by the 

, the initiative expanded to the US in 2009. In 2012, more than 60 countries participated.

	This year, events will be held worldwide on Feb. 28 to bring the cause of rare diseases to the attention of patients, the public, the medical profession, and policy makers. For example, the NIH is sponsoring a two-day conference for researchers and policymakers, including FDA representatives, to raise awareness of rare diseases, bring stakeholders closer together, coordinate policy actions between nations, and emphasize rare disease research and the search for new therapeutics.

	The Orphan Drug Act provides tax credits and marketing incentives for sponsors to develop products for rare diseases. Since 1983, the number of applications submitted and products designated as orphan drugs has continued to grow. More than 400 drugs and biologic products for rare diseases have been approved.  In contrast, fewer than 10 such products supported by industry came to market between 1973 and 1983.

	Drug makers have financial incentives to develop orphan drugs. A 2012 report from Thomson Reuters, 

, estimated the orphan-drug market at the end of 2011 at $50 billion globally, or 6% of total pharmaceutical sales. However, a compound annual growth rate (CAGR) of 25.8% for 2001 to 2010, compared to a 20.1% CAGR for a matched group of non-orphan control drugs, and an increasing number of orphan-drug approvals, suggests that the growth rate of orphan drugs will exceed that of non-orphan control drugs over the next 30 years, according to the report. Because many orphan drugs are biologics, they are less susceptible to generic competition than small-molecule drugs.

	The impact of the smaller population needing the orphan drug is offset by the high cost of the drugs. In fact, the Thomson Reuters study found that 29% of orphan drugs have annual sales greater than $1 billion, about the same percentage as non-orphan drugs.

	While the Orphan Drug Act has spurred the development of life-saving and life-improving therapies for individuals with rare diseases, it also has provided financial incentives for drug companies to invest in these narrow specialties. However, as the sponsors of Rare Disease Day point out, there is still much work to be done.

The US Orphan Drug Act of 1983 defines a rare disease as one that affects fewer than 200,000.