News

FDA seeks transparency ideas

George Miller — Thu, 18 Mar 2010 10:00:22 -0400

As part of its ongoing transparency initiative, the FDA is asking the American public for ideas. It wants to know about the training and education it should provide. Blog

FDA: GMP games may land execs in jail

George Miller — Thu, 18 Mar 2010 08:46:19 -0400

Protracted correspondence between drugmakers and the FDA in sorting out the fixes to GMP violations is likely becoming a high-risk undertaking. The FDA has indicated that from here on in, it will have limited tolerance for manufacturers that make promises they don't keep. Instead of sending stern replies as follow-up to incomplete and inadequate drugmaker responses to warning letters, the regulator is now planning to prosecute.

Top managers at drug companies have in the past been convicted or pleaded guilty to felony acts, according to the Justice Department. Six such cases have involved misbranding and promoting off-label uses, says BusinessWeek. But felony convictions are rare.

Misdemeanors are a different thing, though. And the FDA, in a nod toward a Congress that wants to get tough with drugmakers, has signaled that it intends to pursue such convictions. It plans to do so via The Food and Drug Act, which allows misdemeanor convictions without proof of intent to do wrong--the element that makes felony convictions so hard to come by.

So a C-level stint behind bars may become the consequence of poor follow-up to promised GMP fixes and less-than-complete disclosure of manufacturing foul-ups. Recent incidents like the long time lags between company discovery of problems and the reporting of them to the FDA (the recent Tylenol recall), may now have a much higher price tag. So too with unfulfilled promises of corrective action, like those made recently by Sunshine Pharmaceuticals, which prompt warnings that usually ooze exasperation despite inspectors' best attempts at professionalism.

- here's the article

McNeil overhauls Tylenol QA, supply chain

George Miller — Thu, 18 Mar 2010 08:44:35 -0400

Tylenol maker McNeil Consumer Healthcare says it has confirmed the odor-causing culprit and implemented fixes to its QA and supply chain systems in the wake of an arthritis medication recall late last year that mushroomed to a 50-million unit recall encompassing several consumer-leading brand medications. The company reported back to the FDA in an early-February letter from president Peter Luther. The letter was just posted to the FDA web site, thanks to a New York Times freedom of information request.

McNeil, a unit of Johnson & Johnson, hired a forensics lab to confirm its suspicion that the breakdown of a preservative used on wooden pallets was the culprit behind an odor in the products and packaging that sickened some drug takers. The specialized lab, whose name is redacted in the letter, performs part-per-trillion-level testing via a process that can handle just eight samples per day, according to the letter.

As a corrective and preventive action, McNeil says it now requires suppliers to ship drug ingredients and packaging components on heat-treated pallets, rather than those treated with the preservative. McNeil says also that it is destroying on-hand components that had been shipped on pallets that the company could not confirm to be preservative-free.

The company also has named Veronica Cruz VP for quality assurance, moving her from the quality operations VP spot at J&J's global pharma supply group. Additional fixes in the wake of the incident include changes to the company's field alert reporting and investigation procedures, as well as complaint-review and -handling procedures.

- here's the letter
- read the NYT report

FDA posts observations from Amylin plant visit

George Miller — Wed, 17 Mar 2010 15:51:00 -0400

Disregard of contamination control procedures and improper inspection of raw materials are two of 10 observations made by FDA inspectors during a late 2009 inspection of the plant where Amylin makes the diabetes drug Byetta. The Form 483 report was released last week, just as regulators issued a complete response letter for a long-acting version of the drug.

As we have reported, the new formulation, Bydureon, is being delayed because of labeling, risk strategy, and manufacturing process concerns, none of which are related to the Form 483 citations. "All of those observations have been addressed," the company says in an announcement.

The troubled plant, which is near Cincinnati, was also cited for failing to test in-process materials properly, and for lack of follow up on investigations into batch failures. Training and the following of procedures were also issues.

- see the Form 483
- here's the announcement

GSK may share Canadian vax market

George Miller — Wed, 17 Mar 2010 15:48:00 -0400

GlaxoSmithKline's vaccine delays last year--combined with borders that remained open as H1N1 made its global rounds--are causing the federal government of Canada to rethink its vaccine strategy. The government wanted a supplier based in Canada in case things got so bad that countries closed their borders, shutting off outside supply. GSK, with a plant in Quebec, became its sole supplier

But production difficulties encountered when the pharma giant switched from making adjuvenated H1N1 vaccine to a non-adjuvenated version left Canadian officials with a predicament: They believed at the time that they needed vaccine quickly, but it appeared that finding a supplier and the required ramp-up time would exceed the flu season window.

Officials are now considering a second pandemic vaccine supply contract and want to find out if the idea is feasible and will provide value. Officials would retain a primary supplier in-country, but would also engage a backup. The latter may also get a portion of the country's seasonal vaccine business.

Officials say they will meet industry representatives at the end of March to discuss contract options and learn about drug company advances in vaccine-making technology. The GSK contract runs through March 2011.

- see the article

UPDATE 2: Lilly hit hard in warehouse heist

George Miller — Tue, 16 Mar 2010 20:53:39 -0400

Eli Lilly has identified the eight prescription drugs valued at $75 million that were stolen fom its east coast distribution center in Connecticut on Sunday. The list includes familiar and not-so-familiar-sounding treatments for depression (Prozac, Cymbalta, Symbyax), psychosis (Zyprexa), cancer (Gemzar and Alimta), ADHD (Strattera), and the blood-thinner Effient. A company announcement released yesterday details drug and lot codes.

The drug giant continues to work with police and federal investigators to prevent the drugs from appearing on the black market.

In a departure from the recent M.O. of in-transit drug cargo thefts, emboldened thieves hit the Enfield, CT, facility by cutting through the roof, rappelling into the warehouse, and disabled the alarm, according to reports. East coast operations are shut down and the company is meeting demand by shipping drugs from other sites, according to a local newscast.

The heist may well represent a step up in drug thievery, given the initial targeting and "Mission: Impossible"-style execution in the rainy late-Saturday/early-morning Sunday hours. This was no hit and run operation: The thieves likely worked two hours or more, picking, packing and loading the estimated 70 pallets.

Cargo thefts lately have been more common at terminals, carrier lots, and truck stops. Freightwatch International, among others, notes that cargo thieves are becoming better organized, at times targeting high-value drug shipments.

Last May, Lilly suffered a $37 million loss of insulin as a truckload from the company's Plainfield, PA, stopped for fuel. Thieves jumped in and took off, according to Freightwatch, in a USA Today report. A report of the theft by the driver led to quick recovery of the abandoned vehicle.

- here's Lilly's release on the theft
- read the WSJ report
- see the local Hartford Courant article

Editor's note: Article updated to include additional details about the theft and Lilly's statement.

Disposables penetrate new vax processes

George Miller — Tue, 16 Mar 2010 09:37:01 -0400

Process remains the determining factor for whether single-use technology is a fit in a bioprocess operation, says Janice Abel, principal consultant at ARC Advisory Group. High-volume production processes are likely to remain steel-based for the foreseeable future, she says, but not necessarily indefinitely.

Abel says in a phone interview that although disposables are seeing rapid adoption among drugmakers whose biopharma products are in development, as well as those adopting processes that are new to their operations, the technology is beginning to penetrate more established bioprocess bastions.

One vaccine maker, for example, is using 10-liter disposable bags to replace stainless steel packaging for shipment to a syringe-filling site. The change was justified on the basis of shipping costs alone, she says.

Such a cost justification is a departure from the more common disposables justifications involving short-run manufacturing for clinical trials and new-process development. Abel says she expects disposables to further penetrate vaccine production, and to become integral in the production of personalized medicines.

High-volume production currently remains problematic for the technology, though. Single-use products generally can't accommodate the 10,000- to 20,000-liter quantities required of some drugs, she says. But even that limitation appears to be diminishing. Disposables-maker Xcellerex currently offers a 2,000-liter single-use bioreactor and has a 5,000-liter model in development, according to Jon Lieber, CFO, via email.

"Disposables are here to stay," says Abel. She is co-author of the recently published Disposables Help Drive Operational Excellence in Pharmaceutical and Biotech Manufacturing, which we reported last week. The technology contributed financial gains to disposables makers Pall and Sartorius Stedim recently.

- here's more on Pall and Sartorius

Guidance tells how to skip the sterility test

George Miller — Mon, 15 Mar 2010 22:18:45 -0400

Drugmakers using a sterility assurance release program can take a pass on sterility testing of finished units, according to FDA guidance. In a parametric release program, a drugmaker's demonstrated control of the sterilization process allows it to use defined critical process controls to meet 21 CFR regulations. "Meeting the requirements of the parametric release process can provide greater assurance that a batch meets the sterility requirement than can be achieved with a sterility test," according to the guidance. Report (.pdf)

FDA's Sharfstein talks REMS, track and trace

George Miller — Mon, 15 Mar 2010 21:57:00 -0400

Be on the lookout for FDA guidance on unique identification for prescription drug packages, says FDA principal deputy commissioner Joshua M. Sharfstein, speaking to the U.S. House of Representatives last week. The unique IDs will help in identifying "the whereabouts and authenticity of drug packages and distinguish them from counterfeits."

Sharfstein notes that the FDA Amendments Act requires development of standards for the identification, validation, authentication, and tracking and tracing of prescription drugs and the ingredients that go into them. In attendance was Commerce Committee chairman Henry Waxman, who says drugmakers need to step up their efforts at drug safety. "We need to place a greater onus on all manufacturers to oversee the safety of their own products," according to a press report.

Sharfstein acknowledges pharmas' efforts, citing some as "terrific," while agreeing that still more needs to be done. "We are working with industry to help them strengthen the safety of their supply chains," he says in his prepared comments.

He also describes the FDA's authority to require risk evaluation and mitigation strategies (REMS) for some drugs, with the goal of ensuring that the benefits outweigh the drug's risks. REMS design requires "a careful balancing" of risk management and patient access to medications. "Since using this authority is a work in progress, FDA is committed to addressing the concerns we have heard" from the factions affected, he says. He promises a public meeting.

- read Sharfstein's remarks
- here's the Reuters report

Merck, GE, IBM collaborate on vaccine plant

George Miller — Mon, 15 Mar 2010 21:55:27 -0400

Plans are coming together for a major vaccine manufacturing plant intended for quick response to biological, chemical and radiological attacks. The University of Pittsburgh Medical Center envisions an academia-industry-government collaboration, and it's drawing in some big names.

Merck will provide drug development and bioprocess counsel in a planned consortium of biopharmas. R&D giant Battelle will provide pre-clinical research, as well as model development for infectious diseases and for evaluations of product safety and efficacy. Battelle's services extend to the licensing of vaccines and therapeutics. IT will be provided by IBM.

These big guns join GE Healthcare, already at work with UPMC, which sees the venture as a federally funded non-profit subsidiary.

- here's the article

Daiichi wants payback for Ranbaxy fixes

George Miller — Mon, 15 Mar 2010 21:54:31 -0400

Despite manufacturing mishaps that ultimately blocked some 30 Ranbaxy drugs from U.S. sales for the last year and a half, Japanese parent Daiichi Sankyo maintains great expectations of the generics-maker. Daiichi president Takashi Shoda says not only that he expects the FDA import ban to be lifted by 2012, but that the Indian subsidiary will serve up 23 percent of the aggressive Japanese pharma's earnings that same year, rising from 15 percent today--that's 270 billion yen, rising from 148 billion yen.

The regulatory waters started getting hot for Ranbaxy in 2008 on its home turf: manufacturing defects at its Paonta Sahib and Dewas facilities in India were compounded by falsified data, eventually led to the import ban. More recently, Ranbaxy's U.S.-based unit, Ohm Laboratories in Gloversville, NY, went several rounds with the FDA, which ultimately described the drugmaker's corrective actions "inadequate," as we've reported.

The company showed some seriousness at getting its act together when it pulled in high-end consultancy PRTM to get things moving at Ohm, and when Daiichi Sankyo sent a QC exec to Ranbaxy.

The FDA is "troubled" by Ranbaxy's manufacturing and data integrity issues, according to a New York Times article, and promises to focus on the company until "fully satisfied" with the quality of its drugs and the integrity of its data." Daiichi Sankyo and Ranbaxy executives have put together a joint task force to make sure quality-control systems are in place and will improve, she said.

- here's a press report
- see the NYT article

It's air vs. sea in cold chain battle

George Miller — Mon, 15 Mar 2010 21:52:53 -0400

Watch as air carriers attempt to outdo one another in service offerings--to pharma's benefit. Temperature-controlled and pharma shipping in general are expected to lead the air cargo business recovery. But dropping yields will accompany the pick-up, leading to heightened competition and carriers cozying up to drugmakers.

Consultancy Oliver Wyman, collaborating with the International Air Transport Association, finds in the 2010 global air cargo CEO survey that the most immediate investment priority among the cargo chiefs is e-freight; cold chain capabilities rank near the top, along with security improvements and lightweight containers.

Long-time drug carrier Continental Airlines is watching an influx of competition from the likes of Air Canada, American Airlines, British Airways and Nippon Cargo, as we've reported. The air cargo execs say they expect customers to remain "highly price-sensitive," and to evaluate alternative transport modes for the less time-sensitive shipments.

They're right, of course. Sea carriers are casting for pharma business by boosting their cold-chain options and expanding reefer vessel services. Management consultancy Novumed projects "especially strong growth for temperature-controlled pharmaceutical transport," and says high-end shippers are beginning to offer premium services that curb damage to temperature-controlled drug products.

- here's the announcement

Guidance sharpens drug distribution

George Miller — Thu, 11 Mar 2010 08:03:24 -0500

HOLLIS, NH - Like the case with drug-manufacture outsourcing, handoffs are critical in drug distribution. Especially for drugs that require cold. But in contrast to highly regulated and scrutinized drug manufacturing, the so-called last mile of a drug's journey to the patient is a kind of regulatory Wild West.

"The challenges are in the handoffs between modes: shipper to truck, truck to air, air to truck. These are the areas where operations and logistics planners need to focus," says Anthony Rizzo, a strategic account engineer at Cold Chain Technologies. And contingency planning is important to reducing risk. "The ultimate goal is to protect product integrity," says Rizzo.

He and members of a Parenteral Drug Association task force authored the recently published 38-page TR-46, Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User. Rizzo spoke last night to about 75 members of PDA's New England chapter.

Despite the prominent role of drug wholesalers in U.S. drug distribution, the regulations and guidelines governing them are vague. "There's not enough detail," he says. Some of the guidelines even include such terms as "adequate" and "appropriate" as specifications. "Once a product entered the supply chain, it was a crapshoot."

Rizzo places good distribution practices at the end of the GxP chain. "They are a natural extension of good manufacturing, clinical, and lab practices."

- see the TR-46 Intro and Contents pages (PDF)

REMS sans registry may get one

George Miller — Wed, 10 Mar 2010 16:51:42 -0500

In backing the approval of InterMune's pirfenidone for idiopathic pulmonary fibrosis, an FDA panel voted that the drug's safety had been adequately assessed, despite some concerns. Panelists urged InterMune to track long-term safety data via a patient registry, an item missing from the company's proposed risk evaluation and mitigation strategy. InterMune says it's open to whatever the FDA deems necessary in its final decision-making. Article

ISPE guide tackles automated manufacturing

George Miller — Wed, 10 Mar 2010 16:49:41 -0500

Achieving automated control and compliance of drug manufacturing, at both the project and operations phases, is among the topics covered in the newly released GAMP Good Practice Guide: Manufacturing Execution Systems. MES, according to the document, can aid in automating and coordinating compliance, project, and operations activities.

The 144-page ISPE guide describes MES for regulated industries as a collection of manufacturing-related functions that integrate business and process controls, information flow, and human interaction. The intent of the guide ($380; $145 for members) is to help users narrow their interpretation of regulatory standards for improved compliance.

Manufacturers generally see a return on their MES investments in one to three years, says Christian Woelbeling, senior director at MES maker Werum, speaking recently at a user forum in Japan. The right-first-time approach benefits manual manufacturing processes in particular, he says. And the review-by-exception approach can "dramatically reduce" batch release approval times.

- here's the Guide announcement
- see the Werum forum summary

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Pharma lags food in automation
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UK group pilots anti-counterfeit program

George Miller — Wed, 10 Mar 2010 16:47:38 -0500

Pilot runs of an electronic drug tracking and authentication program have been completed successfully by SecureTrace, a U.K. drug counterfeit-fighting syndicate. The program, led by authentication solutions provider Authentix, traces each step of a drug's supply-chain journey.

The starting point is a high-speed packaging line at drugmaker Reckitt Benckiser. Drugs get a unique and secure 2-D barcode imprint that contains authentication markers in the ink. A laser surface authentication system then generates a fingerprint. Pack data is assembled into cartons, which are marked with barcodes and RFID labels.

A master database stores the ID information; field readers provide authentication and verification of the product throughout the supply chain.

Separately, the Rx-360 pharmaceutical supply-chain consortium has launched an audit-sharing pilot program to collect audit reports and data from 30 suppliers in North America, Europe, China and India. The idea is to make available suppliers' existing audit data to sponsors, so drugmakers can better gauge what additional auditing--if any--they need to do. The pilot's objective is to see how useful audit sharing is to consortium members.

- here's the SecureTrace release
- see the Rx-360 article

Supply chain goes personal

George Miller — Tue, 09 Mar 2010 19:17:19 -0500

Supply chain management is to personalized medicine as the mortar and pestle are to risk-based manufacturing. Both are nearly contradictory concepts in technical terms. Yet the new can't exist without the traditional fundamental pieces of the old, as conceptually mismatched as they may be.

Personalized genetic treatments must necessarily be preceded by personalized genetic diagnoses. So here the new supply chain begins, and it's a far different starting point than that of traditional drug chain. Lab results will drive medicine development, rather than merely suggesting treatment options and providing dosage guidelines for existing drugs traveling a well-worn path to patients.

Those with a stake in personalized medicine are beginning to create the necessary infrastructure, reports research publisher Miller-McCune. It's a far more data-intensive infrastructure than that of its predecessor, despite recent updates.

Drug distributor McKesson, for example, is creating electronic guidelines that help doctors determine when to order genetic tests. It's also building a database that tracks which health plans pay for DNA tests. The idea is to fit personalized medicine into current commercial processes.

- read the article

Sartorius, Pall reap vaccine-gear bounty

George Miller — Tue, 09 Mar 2010 16:22:21 -0500

Sartorius Stedim Biotech credits much of its 2009 financial success to sales of single-use products for vaccine production. "High demand was driven by vaccine manufacturers who required considerable quantities of single-use bags and filters used in the production of the vaccine against the H1N1 virus. This effect contributed around two percentage points to growth," the company reports to shareholders.

Order intake for the biotech division jumped 12 percent, thanks in large part to the disposables. The good news is balanced by bad: Its large-scale bioreactor systems business "slightly declined."

"Pharmaceutical manufacturers are increasingly switching from stationary installed stainless steel equipment to flexibly deployable single-use products made of plastic," the company says. It promises to launch "highly attractive new products" in 2010.

Pall Life Sciences, too, reports better than 10 percent biopharma sales growth for the quarter that ended in October 2009. "Sales within pharmaceutical submarkets increased 9.8 percent with strong consumables growth in all geographies. Vaccine production remains high," it told shareholders.

- see the Sartorius annual review
- here's the Pall report

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

Related Articles:
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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