News

Former Pfizer pill plant available

George Miller — Tue, 09 Mar 2010 06:53:10 -0500

The 230,000-square foot Ann Arbor facility closed by Pfizer in 2008, following a $250-million expansion six years earlier, is being scrutinized by owner University of Michigan. The school considers the pill-making and -packaging operation--part of a 2-million-square-foot complex--a potential magnet for public-private partnership. Article

Aurobindo boosts CMO wave in Asia

George Miller — Tue, 09 Mar 2010 06:31:36 -0500

Indian API maker Aurobindo Pharma has become the latest scrambler for the manufacturing services bounty expected from a morphing drug industry model. Whether or not that bounty will actually enrich the multiplying service-provider population appears at this point to be of less concern than the preparation, positioning, and posturing for it.

The newly formed AuroSource division will vie for part of the 43 percent rise in custom manufacturing projected for India by consultancy Ernst & Young last summer. AuroSource offerings include customized services for APIs, intermediates, pre-formulations and formulations. The division also provides scale-up services and intermediates prep. In addition, manufacturing support, regulatory services and R&D are part of its mix, as are process optimization, purification, and alternate processes.

Aurobindo has 15 manufacturing facilities for both APIs and finished dosage forms, ten of which have passed FDA scrutiny. And that's with the regulator increasingly watchful of both contract and sponsor drug-making facilities in India, as we've reported.

Hindustan is not the only nation jumping on the contract-services bandwagon. Market-watcher Frost & Sullivan notes that looming to the northeast, CMO multiplication is accompanying the overall rise in pharma manufacturing in China.

- here's the Aurobindo report
- see the China CMO article

Labels deal supports drug authentication

George Miller — Mon, 08 Mar 2010 16:41:26 -0500

BP Labels has been picked up by U.K.-based Filtrona's Coated & Security Products division, maker of Payne Tear Tape and Payne Security products. The latter include brand-protection solutions incorporating overt, covert and forensic technologies.

The acquisition furthers CSP's objective of providing creative and secure packaging solutions. BP, which runs ISO-qualified production facilities in Cardiff, produces secure self-adhesive labels for pharma and other industries. The labels are used in authentication solutions.

The announcement comes on the heels of a capsule-shell encryption deal between Pfizer and brand-protection tech supplier NanoGuardian, and the unveiling of a materials-based nano-structure technology for item-level protection by Bilcare, as reported.

- see the release

Disposables seek validation aids

George Miller — Mon, 08 Mar 2010 16:39:34 -0500

Single-use technologies provide automation suppliers the opportunity to develop and offer validation-ready templates or protocols and modular equipment control strategies that simplify validation. In addition to minimizing facility set-up time and cost, such offerings might also help the fledgling single-use market develop.

Disposable technology has enjoyed "rapid adoption" over the past five years, according to Janice Abel and John Blanchard of ARC Advisory Services. They have penned a report, Disposables Help Drive Operational Excellence in Pharmaceutical and Biotech Manufacturing, which finds most of the adoption occurring for clinical and smaller scale production. Future applications, they say, will also include production of vaccines and personalized medicines.

The combination of automated validation aids and single-use processing could help move vaccine manufacturing closer to the populations in developing countries that often can't access them. Modular single-use systems, which often contain built-in contamination control measures, offer a kind of quick-set-up facility that removes some of the infrastructure barriers to the construction of production plants in the developing world. And closer to home, Congress listened to a pitch last summer, as we reported, to create a public/private partnership for medical countermeasures vaccine manufacturing based on the technology

The ARC report is available to clients, and to non-clients for a fee.

- here's the announcement

Xcellerex, Humacyte take on regenerative medicine

George Miller — Mon, 08 Mar 2010 14:16:24 -0500

Disposable bioprocessing technology is taking a step forward in a deal between platform- and service-provider Xcellerex and extracellular matrix tissue-maker Humacyte. Xcellerex will scale up production for Humacyte's regenerative medicine product using a single-use bioreactor system and bioprocessing platform to produce large-diameter vascular grafts.

The Humacyte process of growing grafts from sample tissue involves a lengthier and more complex process than that of most biopharma production processes. "Tissues take longer to grow," says Parrish Galliher, founder and CTO at Xcellerex, in an interview. "For organs and tissues, it's months. The bioreactor system has to be robust to work reliably for months at a time."

During development, the Humacyte process has run on traditional glass bioprocessing gear. The cells grow on a matrix that helps them form the vascular graft. "Cells for tissue grafts are more sensitive than the workhorse cell lines used to make drugs," says Galliher. "They require more sensitive controls for temperature, pH, oxygen levels and fluid shear."

Under the contract, Xcellerex is transferring the Humacyte process to the XDR single-use bioreactor system and FlexFactory platform. The service provider is building the portable production system at its location and perfecting the methodology for single-use production. Humacyte will use the grafts for preclinical development, and the deal may extend to large-scale manufacturing for clinical and commercial use.

- here's the Xcellerex release

Four contractors team for drug development

George Miller — Fri, 05 Mar 2010 16:38:27 -0500

WALTHAM, MA - An alliance among four service providers aims to ease project management and to smooth hand-offs between drugmakers and contractors throughout the various stages of drug development. The companies are Avantium, Xcelience, Cambridge Major Labs, and Beckloff Associates. Their respective areas of expertise are crystallization, formulation, API, and regulatory compliance.

The four have hit the road, speaking to about 40 VPs, directors and other high-level titles from Boston-area pharma and biotech companies. The concept involves alliance project managers who can assume many of the tasks of a pharma drug-development project manager, and who maintain the same entire-development-cycle view of the program or project.

Each member company has named an alliance project manager. These managers, already accustomed to collaborating with one another, work with and on behalf of their pharma client project managers, taking the lead on consensus building among the internal and external team members. The alliance project manager also establishes and maintains a communication loop via regularly scheduled conference calls.

"It seems like common sense, but very few of us actually do it," says Brian Scanlan of Cambridge Major Labs, about the timeline consensus building and ongoing communication. They are his chief silo-busting tools, for "breaking down the natural barriers between functional areas," he says. The process, done correctly, amounts to "in-process technology transfer" rather than the segregated activities that typically precede project handoff to a contractor.

The alliance is perhaps most attractive to resource- and production-constrained small biotechs. But the partners make a case for big pharma companies as well, through the varying degrees of project management available and through a la carte selection of alliance members or contractors of the drugmaker's choosing. They make a case to venture capitalists, too, who may want to get more deeply involved with portfolio company operations.

Each alliance member serves as an entry point to the collaborative, with the lead taken by the project manager of the company contacted. Additional Chemistry Playbook presentations are planned for San Francisco, Research Triangle Park, and San Diego.

- here's alliance information

Orphanage to boast high-containment lab

George Miller — Thu, 04 Mar 2010 06:09:11 -0500

Design engineering efforts begin this month on a high-containment facility for an orphanage in Kenya. Alliance Biosciences will provide design, build, and operations consulting for a diagnostics lab at the Nyumbani Children's Home near Nairobi. The lab will provide HIV and TB testing for the home's 100 abandoned HIV-positive infants and children as well as local residents. Release

Stirling takes over Canadian plant

George Miller — Wed, 03 Mar 2010 20:33:07 -0500

Australia's Stirling Products has acquired a pharmaceutical manufacturing facility in Cape Breton, Canada, purchased "at a major discount" to its $20 million going-concern replacement value. The deal follows the collapse of an unnamed Canadian pharmaceutical group and its institutional lender.

The cGMP-compliant facility is operational, and Stirling plans to take possession this week. The company cites the purchase as in line with its global positioning strategy. An industry press report says that Stirling may use the facility for third-party contract manufacturing of generic drugs, funded research, and drug production.

The facility is fitted with lab and drug manufacturing and packaging equipment. It includes water filtration systems, auto-mixing units to 3,000-kg capacity, and automated filling, labeling and packaging lines. Annual capacity is reportedly 550 million tablets, 5 million bottles and blend up to 1.5 million kg of product. It also has a granulating and grinding capacity.

- read the article

Sentry delivers for CDC vax reserve

George Miller — Wed, 03 Mar 2010 20:32:03 -0500

The U.S. Centers for Disease Control & Prevention has chosen Sentry BioPharma Services to store and distribute influenza vaccine for the national strategic reserve. The cold-chain logistics service provider will warehouse and distribute vaccine from its cGMP, FDA-registered facility in Indianapolis. Sentry CEO Jennifer Marcum says in an announcement that the company has a history of supporting the CDC for vaccine distribution that requires temperature maintenance.

She adds that Sentry facility, systems and processes meet CDC recommendations for vaccine storage and handling.

Sentry is hardly the only logistics service provider sensing gold in the cold. United Cargo and DHL Global Forwarding are among others that have launched temperature-control services and invested in infrastructure.

- see the release
- here are the CDC recommendations

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India considers plant restarts

George Miller — Wed, 03 Mar 2010 20:31:01 -0500

India is rethinking its decision to shut down three aging manufacturing plants in light of a vaccine shortage. The facilities were closed two years ago for standards violations. They produced bulk vaccine for diphtheria, tetanus and tuberculosis.

The state-owned units include the spry BCG Vaccine Laboratory in Chennai at 60 years, the 100-year-old Pasteur Institute of India at Coonoor in Tamil Nadu, and the 103-year-old Central Research Institute at Kasauli in Himachal Pradesh. A health official asked the government to restart the facilities immediately and bring them up to quality standards.

A local press report says that production of some of the vaccines was halted with the plant closings. Commercial drugmakers offered to meet demand, but they required lead time. Interim shortages left some of the most populated areas without vaccines, especially the one for TB. India has the largest incidence of TB in the world, according to the article.

The call to revive the facilities comes as big-name vaccine makers set up shop in India. As we've reported, Novavax, Novartis and Sanofi are three of the more recent companies making a play in the country through joint ventures, acquisitions and new facilities--not just to meet in-country demand, but also because of lower manufacturing costs.

- here's the article

Freeze-dry value on the rise

George Miller — Wed, 03 Mar 2010 20:30:05 -0500

Complex chemical molecules need complex vehicles for accurate targeting in the body. Increasingly, drug developers are turning to lyophilization as a step in achieving their formulation objectives. Freeze-drying is also growing in importance in manufacturing, thanks to more frequent instances of compounds having low solubility.

Low-solubility issues rear their heads after a compound's initial development stages, says PharmTech. One workaround involves freeze-drying techniques that include organic solvents rather than the more common use of co-solvents, which can complicate formulation.

Freeze-drying techniques--for both formulation and manufacturing--are eligible for patenting and may eventually become part of a company's intellectual property.

- read the article

Pfizer takes on counterfeiters

George Miller — Tue, 02 Mar 2010 15:30:28 -0500

Pharma giant Pfizer is engaged in a two-pronged attack on drug counterfeiters. The maker of Viagra--among the drugs most targeted by counterfeiters--is actively involved in tracking the crooks at the same time it educates a distracted public about the dangers of fakes.

The big pharma worked with Immigration & Customs Enforcement agents in Houston to catch Kum Leung Chow, owner of Kingdom International Enterprises, who now faces federal felony charges for trafficking in counterfeit goods and selling misbranded pharmaceuticals.

Pfizer investigative staff approached the customs agents about the Viagra knock-offs being sold online. Agents then arranged the first of several controlled deliveries. And they went to Pfizer and Lilly labs for testing of the pills, confirming them as counterfeits.

Separately, Pfizer published research and launched an Internet site concerning the use of counterfeits in Europe. In surveys last fall, it found "a massive black market economy generated by counterfeit medicines," the company says. Its Cracking Counterfeit Europe report, published in mid-February, finds that 20 percent of the 14,000 survey-takers admitted to buying prescription-only medicines from illicit sources. Some 5 percent said they believed a drug purchased without a prescription online was always genuine. Pfizer estimates that as much as 90 percent of medicines bought online are fake or may contain too little or none of the active ingredient.

- see a chronicle of the Chow incident
- read a summary of the research
- visit the counterfeiting Internet site

The world's most expensive drugs

George Miller — Tue, 02 Mar 2010 08:33:44 -0500

Genzyme drugs take four spots among the most expensive in a Forbes survey (chart). The developer's rare disease treatments Myozyme, Fabrazyme, Cerezyme and Aldurazyme all cost over $200,000 per year. But the Cerezyme price is likely to head south following last week's FDA approval of Shire's Gaucher treatment, velaglucerase alfa for injection. Alexion Pharmaceuticals takes the top spot for the world's most expensive drug, Soliris. The therapy costs $409,500 per year. Chart | Article | Genzyme release

New website serves REMS writers

George Miller — Tue, 02 Mar 2010 07:17:43 -0500

Consultancy BioTrak Market Intelligence has launched REMSadvisor.com, a resource for those developing risk evaluation and mitigation strategies. REMS have become an increasingly required approval component for drugs that the FDA deems to have safety risks.

The Internet site addresses program design, implementation, and assessment, which BioTrak says have been challenging for drugmakers. Content includes methods, guidance, and REMS experiences, some related via video presentations.

The FDA last fall issued draft guidance on REMS format and content, a blueprint for manufacturers developing the safety strategies intended to ensure drug benefits outweigh risks.

REMS are on the rise. The FDA recently required them for erythropoiesis-stimulating agents, setting three manufacturers to the task.

- here's the announcement

Reefer services sets sights on pharma

George Miller — Mon, 01 Mar 2010 21:00:15 -0500

Contargo is expanding its network of reefer vessel service stations. And Ge-eX Logistics says it is entering the "very demanding but growing temperature-controlled sector" of the reefer container transport market.

Contargo is working with Smith Netherlands to offer reefer services at terminals in Frankfurt and Duisburg, Germany, expanding its existing network. The German locations follow Contargo's 2007 opening of its Basel Multi Terminal and the opening of another station at Terminal Ludwigshafen the following year. The container logistics specialist is targeting pharmaceutical products by offering security, surveillance and equipment reliability.

In the collaboration, Smith Holland employees work at Contargo facilities and use its cargo handling, transportation and fuel resources. Standardized cooling-system inspections and reefer repairs are provided.

Separately, Ge-eX says it is stepping up to customer requests for closed-loop supply chains with its reefer offering. It boasts new 45-foot ships equipped with in-transit temperature monitoring. The Ge-Fresh Logistics business will target Benelux, U.K., Ireland and Scandinavia initially, with plans to reach Italy in 2011.

- see the Contargo report
- here's the Ge-eX announcement

Bioprocess experience a plus in 2010 hiring

George Miller — Mon, 01 Mar 2010 20:58:46 -0500

Experienced bioprocessing professionals will likely remain in demand this year, compensating for retirement of the Baby Boomers now holding senior positions. Manufacturing capacity expansion projects are also expected to continue, and bioprocess improvement efforts will target downstream-purification bottlenecks.

Market analyst BioPlan Associates makes these and other projections for 2010 in its 7th Annual Report and Survey of Biomanufacturing. The life sciences research concern says it expects recent trends to continue, but notes that "most companies are more confident, but also more realistic: 2010 will bring good results, but managers are expecting better performance from the same staff."

Cost-containment is expected to continue driving bioprocessing technologies. BioPlan says it expects "improved yields from upstream processing, and better expression systems, host cells and genetic-engineering technologies for large-scale manufacture." In addition, expect upstream expression yields to continue their increase, while downstream purification will continue to struggle.

- here's the article

Related Article:
Operations job gains to offset exec losses

Pfizer to offer encrypted capsule shells

George Miller — Mon, 01 Mar 2010 13:19:30 -0500

Brand-protection solutions maker NanoGuardian has opened its NanoEncryption technology kimono to Pfizer's Capsugel drug delivery systems division.

By mid-year, Capsugel expects to offer both pre-NanoEncrypted capsule shells and the post-fill nanoscale-marking service. The pre-fill service aims to eliminate significant disruption to a drug maker's existing manufacturing process.

NanoEncryption technology imprints overt, covert and forensic security features on capsules, tablets, vial caps, and single-use syringes to fight counterfeiting and illegal diversion. Overt and covert markings allow dose-level authentication, while forensic NanoCodes provide comprehensive tracing information.

Pharmaceutical Commerce magazine reports that coatings and excipients supplier Colorcon announced a similar deal last summer with ARmark Technologies. In the resulting On-Dose ID offering, the latter's nano-scale microtaggants are added to Colorcon coatings.

Separately, Bilcare has unveiled its nonClonable patient safety system. It uses materials-based fingerprints built from micro- and nano-structures for item-level protection, the company says. The fingerprints are tamper-evident labels themselves, or they can be embedded as tags into objects. A reader device provides authentication in the field via database connection

- here's the Capsugel release
- see the Pharmaceutical Commercs article
- read the Bilcare announcement

Walloped with $26M in fines, KV closes ETHEX

George Miller — Mon, 01 Mar 2010 13:18:21 -0500

A combination of multimillion-dollar GMP-violation fines and the likely loss of government contracts have brought the ETHEX generic drug unit of KV Pharmaceutical to the end of the road. KV says it is ceasing the St. Louis subsidiary's operations.

ETHEX will plead guilty to two felony counts of failure to file safety-threat field alerts with the FDA in 2008 for the API Dextroamphetamine, used in the attention-deficit hyperactivity disorder drug Adderall, and for cardiac-arrhythmia treatment Propafenone. The company will pay fines of $25.8 million. ETHEX says it will not contest an administrative forfeiture of $1.8 million.

A Department of Justice consent decree prohibits KV Pharma and subsidiaries ETHEX and Ther-Rx from making and distributing adulterated and unapproved drugs, following a raft of recalls in 2009 and an FDA inspection in late 2008. Many of the recalls involved oversized tablets. The FDA seized more than $24 million in products following KV's continued production after an FDA-ordered halt.

The company last fall hired GMP expert Lachman Consultants to oversee a production overhaul. It remains positive publicly. CEO David Van Vliet says the company is "working alongside the FDA in accordance with our consent decree and demonstrating cGMP compliance so we can resume manufacturing and return our products to market."

ETHEX contributed more than 60 percent of KV's revenue in 2008.

- read KV's release

Tobacco may speed vax production

George Miller — Thu, 25 Feb 2010 08:41:09 -0500

As if in answer to HHS secretary Kathleen Sebelius' call last week for faster vaccine production, the Texas Plant-Expressed Vaccine Consortium has unveiled a proof-of-concept initiative for tobacco-based production. Project GreenVax will shoot for 100 million-dose/month capacity in a 145,000-square-foot facility that includes mobile cleanroom pods for specialized purification and lab equipment. Release

Ops job gains to offset exec losses

George Miller — Thu, 25 Feb 2010 08:12:05 -0500

A 9.3 percent increase in pharma manufacturing jobs is expected to redress a 6.6 percent decrease in top executive positions over the next decade, says the U.S. Bureau of Labor Statistics in its Occupational Outlook Handbook (click for chart). The pharma industry, it projects, will grow to 307,000 employees--despite the many big-layoff indicators to the contrary--rising from the 289,000 counted for 2008.

The BLS projects overall pharma industry growth of 6.1 percent. This growth lags the expected 10.1 percent of the entire US economy, says Pharmaceutical Commerce magazine. But it positions pharma near the top of manufacturing sectors, which collectively are projected to fall by 9 percent in 2018.

Cost concerns among both drug makers and buyers will conspire to limit the growth driven by increasing product demand, BLS expects. Continuing improvements in manufacturing processes will improve productivity in pharmaceutical plants.

Pharma manufacturing wages are currently higher than manufacturing industry averages.

- click here to view the full chart
- here's the article
- see the Handbook's pharma section

WuXi plant ok another notch for China

George Miller — Thu, 25 Feb 2010 08:10:26 -0500

The European Medicines Agency has signed off on WuXi PharmaTech's cGMP drug production and analytical testing facilities in Shanghai. The manufacturing plant produces solid oral dosage forms for use in clinical trials. The test facility is used for developing and validating methods of API and formulated drug analysis for potency, purity and solubility.

The facility approvals are another score for China's drug industry, and evidence that the government meant what it said about raising pharma industry quality to the standards observed in most developed countries.

It's at once a bootstrap tale and a comeback story. The People's Republic ranked third among the 20 countries filing patents for aseptic applications in 2008. Its 21 submissions towered over its 2003 accomplishment of just one.

Demand for Chinese APIs, however, dropped in 2009 following high-profile quality problems, as we've reported. But efforts to beef up quality controls, and the adoption of GMP methods, appear to be reversing the trend. Consultancy JZ Med expects 5 percent to 8 percent growth in 2010, with the rate accelerating through 2015.

- here's the WuXi announcement

HIV vax facility plans for sale

George Miller — Wed, 24 Feb 2010 14:41:31 -0500

Some $750,000 later, the Ottawa International Centre for Infectious Diseases will not be building the HIV vaccine manufacturing plant it had designed to answer a government call. Nor will three other institutions.

All four responded to a request for bids for a world-class facility to be built and operated with funds from the government and the Bill and Melinda Gates Foundation, as reported earlier. Each was informed independently that it had not won. Several weeks of silence and puzzlement followed, as all learned that none had won.

But the mystery ended late last week when the Public Health Agency of Canada confirmed that the project had been scrapped. "The Government of Canada and the Gates Foundation have decided not to proceed," says a government announcement.

The $88 million pilot manufacturing facility was to be part of a $139 million partnership between Ottawa and the Bill and Melinda Gates Foundation. The facility would have provided manufacturing capacity for HIV vaccines from researchers around the world for use in clinical trials.

Though the government says that the Gates Foundation concluded the facility was unnecessary, speculation has been that politics or big-pharma influence may have forced the project's demise.

- see the article

FDA letter vetoes Lilly API test

George Miller — Wed, 24 Feb 2010 14:11:17 -0500

Eli Lilly is the recent recipient of an FDA warning letter concerning adulterated API at a manufacturing facility in Puerto Rico. In the letter, the regulator charges that the drug giant shipped 24 of 36 batches of substandard Lyspro Insulin Zinc Crystals, based on results from tests not validated for that purpose.

The letter also states that the company knew of a similar case of adulteration (details of which are removed from the Internet version of the letter) at another of its facilities, and that the manufacturing team at that facility rejected the material and then cleaned the equipment involved. The API is used in the diabetes drug Humalog.

Eli Lilly responded to the FDA in late August, following the inspection last July. In its response, the drugmaker promised to stop using the unapproved test as an indicator of continued processing. It also promised to enhance its cleaning activities related to the event and to improve its visual inspection techniques.

But the promise was not enough, as has been the case recently with the regulator. The FDA requested additional details on the changes to both the cleaning and inspection procedures. The FDA also found the response lacking because it failed to demonstrate why the 24 released batches were suitable for use.

- see the warning letter

Genzyme paying big for GMP slips

George Miller — Wed, 24 Feb 2010 14:09:39 -0500

For those who may sometimes think that manufacturing operations are hands-on work removed from the high-falutin' business of the executive suite, take a good look at Genzyme. Whether the manufacturing team had a momentary lapse, or the company's creaky manufacturing infrastructure began its inevitable crumble, manufacturing matters at the Boston area plant are what has driven both the company and its long-time leader to the edge.

To a corporate executive, the situation can't get much worse than when Carl Icahn starts planning his path, with friends, to your board, as the New York Times reported Tuesday. Genzyme has scrambled to correct its manufacturing problems, which began in the fall of 2008, by hiring consultants and working with the FDA to bring the plant back up to snuff. And it's farmed out work and moved production to its other facilities to keep business going, even after competitors were granted early market access by FDA to fill a shortage of its specialty drugs.

Its ops restructuring, especially the placement of Eli Lilly manufacturing vet Scott Canute as president of global manufacturing and Sandra Poole as senior VP and site leader at the embattled facility, are moves that can serve the company well for a long time to come. But only if Genzyme and Termeer remain as innovative as they have been for nearly 30 years.

- here's the Times article
- see our coverage of Genzyme's manufacturing issues
- here's our GMP violations coverage

Vaccine process shuns the cold

George Miller — Mon, 22 Feb 2010 22:09:38 -0500

The Hypodermic Rehydration Injection System (HydRIS) yields vaccines that can be stored in tropical heat, say collaborators Nova Labs and Oxford University. The process involves mixing live vaccine with common sugars, dripping the substance onto a glass fiber membrane, and then drying it in low-humidity at room temperature. Video and article

FDA grants controlled substance approvals

George Miller — Mon, 22 Feb 2010 22:08:56 -0500

Pharmatek Labs has cleared Drug Enforcement Agency requirements for the development and manufacture of Schedule 4 and 5 controlled substances. The contract manufacturer's facility design, security systems, and procedures for manufacturing, handling, storage and disposal all meet DEA approval

Separately, India's Sun Pharmaceuticals last month received approval for generic hydocodone bitartate with acetaminophen (APAP) tablets--its first FDA approval for a controlled substance.

The regulator recently published Assessment of Abuse Potential of Drugs, draft guidance for manufactures developing drugs that have the potential to be abused. The guidance, required with applications for new drugs that may be abused, describes what to include in the assessments, including a proposal for scheduling and study design.

- here's the Pharmatek release
- see the Sun's announcement
- check out the draft guidance

Roche envisions China as generics-maker

George Miller — Mon, 22 Feb 2010 22:07:21 -0500

Given the number of potential drug-takers in China and the current emphasis of its government on manufacturing quality, the People's Republic may grow into the role of high-quality maker of local generics, says Luke Miels, head of Roche's pharmaceuticals unit in the Asia Pacific. China's healthcare reform initiative provides another motivation.

"We think this is going to have a fundamental influence on the structure of pharmaceuticals," Miels says.

Roche moved its regional headquarters to Shanghai from Sydney last year. China's higher incomes are being accompanied by a rise in cancer rates and needed treatments. Roche also provides treatment for such local conditions as gastric and colorectal tumors, reports Bloomberg.

Pakistan is also joining the list of countries stepping up to manufacture their own medicines. The Biological Production Division (BPD) of the National Institute of Health (NIH) will, in the very near future, restart basic manufacturing of tetanus toxoid, measles and cell culture rabies vaccines, Federal Minister for Health Makhdoom Shahabuddin was informed during his visit to NIH here on Wednesday.

- here's the China article
- see the Islamabad item

Sea option becoming viable for drug shipments

George Miller — Mon, 22 Feb 2010 22:05:56 -0500

Trouble is brewing above. Though beleaguered airlines currently have plenty of room for drug cargo--and even appear to be catering to the drug business, as we've reported--they are cutting capacity. As the improving economy re-energizes global commerce in all industries, drug space on aircraft may become hard to find, says Kevin O'Donnell, a director at Tegrant Corp., in Pharmaceutical Commerce magazine.

A dozen vaccines are nearing approval for distribution in developing and middle-income countries, according to the Partnership for Appropriate Technology in Healthcare. And vaccine shipments are getting fatter: PATH projects a five-fold increase in cubic volume for three of these, thanks to the packaging of fewer doses per vial to minimize spoilage. In addition, temperature-sensitive biologics as a whole are growing nicely and projected to represent half of drug approvals by 2015.

These and other elements, when combined, will cause a cargo crunch. "If the airlines move too cautiously, capacity will become an issue," writes O'Donnell. "Even though pharmaceutical freight has a higher priority index than general cargo, there is a real potential that demand could exceed available capacity."

A transport alternative to consider is sea shipment, he says. "While the risk of putting multi-million dollar shipments of brand equity on the waves is not a consideration most pharma companies have entertained in the past, developing technologies for refrigerated sea containers and logistics" makes it worth a second look, according to O'Donnell. He provides a biopharma to-do list to help manufacturers prepare for the coming crunch.

- here's the article

VaxGen story goes beyond manufacturing

George Miller — Mon, 22 Feb 2010 22:04:31 -0500

Though not a manufacturing issue per se, Congressional lobbying is one of its great influencers. Our mention last week of VaxGen's experience in the mid-2000s--in which government funds for an anthrax vaccine were terminated in the final drug approval stages, with dire consequences for the company--is one that still incites strong responses from both the government and the biotech industry.

Peter K. Watler, principal consultant and CTO at Hyde Engineering + Consulting, provides an excellent perspective on behalf of the latter, especially small biotechs struggling against a well-funded competitor, the undefined timeframes of the drug approval process, and its high cost. "VaxGen was a small company and did a more than competent job of developing the anthrax vaccine," says Watler via email. He suggests as a chronicle the 2007 report of an LA Times investigation, conducted while the dust was still settling, which provides far more detail than the New York Times summary article we cited last week.

But our main point remains: vaccine makers need to respond quickly and enthusiastically to HHS secretary Kathleen Sebelius's mandate for weeks-long vaccine production technology, and take control of the process before anyone else does.

- here's the LA Times report
- see the NYT story

CMO deal has U.K. bioprocess focus

George Miller — Mon, 22 Feb 2010 22:02:48 -0500

Discovery and development service provider AMRI has enhanced its manufacturing service offerings through the acquisition of Excelsyn, a U.K.-based contractor for big pharma, specialty pharma and biotechnology customers in Europe, Asia and North America.

Excelsyn boasts rapid response manufacturing services, thanks to a process that speeds in-plant product changeovers. The process capitalizes on flexibility among batch reactors, says an AMRI spokesperson. Reactors can be independently connected and modified to meet the needs of specific processes less expensively than is the case with fixed-reactor trains. The Excelsyn 14-acre site contains a lab, pilot plant and large scale manufacturing facilities.

Excelsyn also provides AMRI access to the U.K. and European markets, which it had been seeking. The company anticipates a boost to its development and manufacturing work, especially in the production of chemical intermediates.

- see the announcement

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