A model which other companies may want to emulate. Genentech's Scholars Program is giving high schoolers scholarships and internships in the hopes of encouraging them to pursue life sciences professions. Would love to hear about similar programs out there . . .

--PWT

Genentech has taken a lead role in advancing the state of Quality by Design for biopharmaceuticals. At this week's BIO conference, Lynne Krummen, Genentech’s senior director of regulatory affairs, shared information on her company’s participation in FDA’s pilot program for biologics QbD.

“We are seeing an increasing frequency of inspections from FDA and the rest of the world,” says John O'Connor, PhD, senior director of Corporate Inspection Management for Genentech. “The question is, what’s the value of a duplicate inspection? We don’t believe it adds value to the product. But it costs us.”

I don’t know about you, but the relentless drum beat of negative news has been getting to me lately.  Every day seems to bring news of some drastic four-figure layoff...er, restructuring, whether in pharma or other industries.

While the term bailout is being tossed around liberally to suggest any government assistance in these challenging economic times, U.S. biotech leaders appear to asking for just that, or at least an indirect bailout. Members of major biotech companies and industry organization BIO will meet with Congress today to ask for changes in currect tax laws that would in effect open to the door to more government funding for the industry.

On Monday afternoon, a manufacturing and operations discussion group focused on the topic of global competition.  Session chair Julian Wilkins, Vice President of PharmaConsult US, Inc. and a part-time professor of Pharmaceutical Manufacturing at Stevens Institute set the stage with an introduction spelling out the issues and challenges.

Before you can achieve a high level of operational excellence, you've got to nail down predictability, says Dr. Patrick Yang, Genentech's Executive VP for Products Operations. Too many companies aim high at the start of operational excellence initiatives, Yang says, at the expense of planned, predictable operations. Predictability is fundamental to operational excellence, Yang says, a prerequisite to all endeavors.

The past few weeks have seen a dramatic increase in mergers and acquisitions, with the generic drug manufacturer Teva buying Barr and Roche bidding for Genentech.  Frost & Sullivan analyst Rhenu Bhuller, pharma industry VP, shared these perspectives. Click here to watch brief video.

Once again, had to miss the best part of this presentation, but did hear Robert Bottone of Genentech discuss the problem that some managers in biopharm and pharma have with Operational Excellence. Many of them still expect “silver bullet’ solutions. This was also a conclusion reached by those who took our recent survey.

Silver bullets simply do not exist, Bottone said. Toyota took nearly 40 years to develop the TPS, so be patient and keep working at it, Bottone suggested. Worthwhile efforts take time.

Decided to ask the panel about error proofing and jidoka and where the industry stands. (For audio of responses, click here). Bottone said that drug manufacturers need to focus on this. William Botha , Director of Operations, Baxter, who will soon publish a book on the subject  of Op Ex(with Wiley) noted the fact that empowering workers is a tough but necessary job. It can’t be done by fiat from a corner office and by patronizing the individual. In addition, he said, operators thrive on challenge. They like it, they need to grow. Fundamental to the whole issue of jidoka and error proofing is respect for the people doing the work. Amen.

BTW, Gwendolyn Galsworth and Martin Hinckley, experts in error proofing and visual systems will be writing regular columns for us on just this topic. This promises to fill a need within pharma and biopharma. Stay tuned.

AMS

 Installment 3 (and, no, sorry, that is not me)

ISPE announced the Facility of the Year 2007 winners at its annual meeting in Las Vegas.

One of our competitors is part of this competition, but there is room for many awards in this sphere. Excellence is excellence, and the Facility of the Year winners have changed the way they handle facilities operations and engineering projects, particularly Genentech, whose NIMO (for New Idec Manufacturing Operations, if you must go there) project in Oceanside, California, won first place this year.

Teamwork has been essential to the project's success, but also helped the company get through the recent California fires. In accepting the award, Genentech’s vice president and general manager of the Oceanside facility, David Broad praised all his colleagues, particularly [apologies if I have misspelled anyone's name] Christophe Label and Victor Vasquez (on the project side), Johannes Robers (who has since left the company), as well as contractors including DPR, CRB Engineering.

"We had three owners and three different processes during the course of this project, but we had great teamwork, “ Broad said.  Apparently, that teamwork came into play recently during the fires, when one quarter of the company's staff had been evacuated. "Despite challenges, we kept operating," Broad said.

At the opening of the Las Vegas meeting, Clive Mullins, Chair of Facility of the Year committee, announced the competition’s groundrules and categories, the winners for 2007 and why they won.

Below, a distillation:

As he said, the awards recognize facilities and projects that use innovative technologies to improve quality and lower production cost. Eligible are any and all pharmaceutical and biopharma facilities that began operation between January 2005 and December 2006… new freestanding facilities, additions, or interior renovations.

Overall categories are:

• Process Innovation
• Project Execution
• Equipment Innovation
• Facility Integraton
• Energy Efficiency
• Operational Excellence

"It’s not a beauty contest,� Mullin asid. “We’re trying to identify innovation and recognize it. He also mentioned that companies needn’t build anything to qualify for the Op Ex Award." (Aside - COPYCATS!)

The team of judges this year was led by Andrew Skibo of Amgen, and entries came from 20 countries.  And the winners are...

Project Execution
Genentech Oceanside Product Operations, NIMO, in Oceanside California, developed an innovative project delivery, “hybrid design build� in which civil, architectural and structural engineering are executed via the traditional design, bid build method, and mechanical, electrical process and instrumentation and controls are completed using the design-build model. The project made use of advanced technology including superskids, wireless technology. Its layout also made maximum use of grey space…

Especially significant was the fact that the facility changed ownership and product focus several times during the scope of this project, yet the team was able to deliver to each owner (Idec, for Tysabri and Genentech, for Avastin) ahead of time and on budget. The plant now produces the cancer therapy Avastin at the facility, and will also manufacture Rituxan, a non-Hodgkins lymphoma treatment.

Equipment and CIP processes are dedicated for each functional area within the facility, and CIP is fully automated, while buffer preparation and storage and valves have been designed to enhance flexibility.

 

Regional Excellence for Project Execution
Shanghai Roche High Potent Production Project (SHIP) – This project was awarded because of its innovative use of technology to ensure dust containment at all workstations. The budget for this project was extremely limited by U.S. standards, at just over $16 million, yet the facility was able to meet international safety standards and to be completed in a short timeframe, despite cultural, geographical, and language barriers entailed.

Equipment Innovation
Taiyo Pharma Industry Co. won for a prefilled syringe manufacturing facility in Takayama city, Japan.The facility uses innovative technologies, including RABS, SCADA systems, and an advanced monitoring system for coated silicon….various apparatuses are used to inspect dimensions, shapes and tip strength. Transfer preventing direct human intervention….

Process Innovations
Vetter Pharma Fertigung won for its contract filling facility (liquid and lyophilized drugs), which uses automation extensively, as well as RABS.

Facility Integraton
Cook Pharmica LLC won for incorporating disposable technologies throughout the manufacturing area. Dubbed “Project Phoenix,� this $70-million project involved facilities that had been abandoned by a television assembly plant before Cook acquired them.

Hallmarks of the project included: unidirectional flow of operators, equipment, supplies and product, use of web cameras, client-dedicated offices and viewing corridrdors providing clients the ability to view production from any location.

There were apparently no winners in either of the following categories: Energy Efficiency or Operational Excellence

Our congratulations to all the winners and others who participated.

Some observers in the non-engineering or science portion of the industry, including the whistleblower behind the PharmaFraud blog, have commented that the award seems boring. 

Well, it may seem that way to the uninitiated, but drugs are not made by some invisible band of globally dispersed Oompa Loompas. This work is bringing down the cost of medications and will make them more accessible throughout the world so...

Hurray for the winners, and to the sponsors for an important award that, despite the "Facilities" in its name, recognizes the people behind drug manufacturing.

For more on Wyeth's Prevnar team and others who won the 2007 Pharmaceutical Manufacturing Team of the Year award, click here.

AMS