Drug Making Breaks Away From Its Old Ways;

'Continuous-Manufacturing' Process Can Improve

Quality Control, Speed Output
Rockoff, Jonathan D.Wall Street Journal (Online); New York, N.Y. [New York, N.Y]09 Feb
2015: n/a.

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2. Abstract/Details

Abstract
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Many other industries adopted such a "continuous-manufacturing" approach years ago,
because quality can be checked without interrupting production--with weeks shaved off
production times and operating expenses cut by as much as 50%. [...]recently,
pharmaceutical companies have been stuck making drugs the old-fashioned way, mixing
ingredients in large vats and in separate steps, often at separate plants and with no way to
check for quality until after each step is finished.

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For decades, drug makers have used cutting-edge science to discover medicines but have
manufactured them using techniques dating to the days of the steam engine.

But now, the industry is moving toward a major upgrade. GlaxoSmithKline PLC, Johnson &
Johnson and Novartis AG are among the companies building facilities to make drugs
differently. Biotechs including BioMarin Pharmaceutical Inc. and Vertex Pharmaceuticals Inc.
are deploying--or are about to deploy--elements of the processes in their production.

Under the new approach, raw materials are fed into a single, continuously running process.
Many other industries adopted such a "continuous-manufacturing" approach years ago,
because quality can be checked without interrupting production--with weeks shaved off
production times and operating expenses cut by as much as 50%.

Until recently, pharmaceutical companies have been stuck making drugs the old-fashioned
way, mixing ingredients in large vats and in separate steps, often at separate plants and with
no way to check for quality until after each step is finished. Any desire to modernize was
partly blunted, industry officials say, by the high margins netted on the industry's string of
billion-dollar-selling drugs.

But companies have lost most of their sales from those blockbusters due to competition from
low-price generic versions, prompting a hard look at their operations and expenses. It also
helps that industry officials expect that the Food and Drug Administration, once viewed as a
potential obstacle because it must sign off on a company's drug manufacturing, will support
the moves.

The FDA, seeing an opportunity to "improve the overall quality" and reliability of drug
manufacturing, began pushing for change in 2004, said Janet Woodcock, who heads the
agency's drugs center.

"The pharmaceutical industry has been so slow to adopt approaches embraced by other
industries, but I think the time is now," FDA Commissioner Margaret Hamburg said during a
tour of Vertex's new continuous manufacturing line in South Boston, which would be one of
the first such facilities to go into production if a new cystic-fibrosis drug is approved in mid-
2015.

A key challenge companies are confronting: developing the expertise and skills to run the
new kind of production, said Paul McKenzie, who had overseen J&J's drug manufacturing
before taking over the company's medical-device R&D this year.

At a factory in Puerto Rico, J&J has built a line that could manufacture the HIV/AIDS
medicine Prezista starting in 2016 using the new techniques if regulators approve. The main
ingredients will still be made elsewhere, but J&J aims to manufacture 70% of its "highest-
volume products" using the processes within eight years, Mr. McKenzie said.

Meantime, GlaxoSmithKline is building a $29 million continuous-manufacturing facility in

Singapore to make respiratory-drug ingredients, starting in 2016. "The industry has a lot
more quality and cost pressure now, so we need to transform our manufacturing paradigms,"
said Mark Buswell, Glaxo's head of advanced manufacturing technology.

J&J, Glaxo and most other companies remaking their manufacturing intend to use the new
approach for the final stages of drug production, not the manufacture of ingredients.
However, Novartis is building a line at a Swiss plant that would make drugs continuously
from the start of ingredient production through the end of coating tablets, according to
Markus Krumme, who heads Novartis's continuous-manufacturing unit.

The upgrades should substantially reduce the risk of product-quality failures, because
companies will be able to make any needed corrections throughout production, not just after
a batch is finished, officials said. The changes will also cut waste because companies won't
need to throw out entire batches if a problem turns up. And production times will drop since
the steps will no longer be performed separately, often in different places.

As a result of such benefits, companies will save an estimated 30% or more in operating
costs, according to Bernhardt Trout, director of the Novartis-MIT Center for Continuous
Manufacturing, which has been developing the new technologies with funding from Novartis.

The continuous-manufacturing plants themselves are expected to cost much less than the
$150 million that a traditional drugmaking factory costs because they require less equipment
and less space, said Marcus Ehrhardt, who leads PricewaterhouseCoopers' life-science
operations business.

The Vertex facility's linked pipes, valves and hoppers take up only 4,000 square feet,
compared with a 100,000-square-foot traditional factory, said Hayden Thomas, a Vertex
manufacturing official. If the company's new cystic-fibrosis drug gets approved, the facility
would make 100,000 tablets in an hour, rather than the four to six weeks that would be
needed to make a batch at a traditional plant.

The biotech had been using contract plants to make its drugs. In early 2012, the board
decided the company should build its own, continuous-manufacturing plant, despite a cost
exceeding $30 million, because its speed would enable the company to make high volumes
of cystic-fibrosis tablets as soon as the drug got approved, said Vertex Chief Executive
Jeffrey Leiden.

Dr. Leiden said there were "hiccups" erecting the new plant, including the challenge of
designing software to run the complex machine. To reduce the risk that the plant wouldn't
pass FDA muster, Vertex said it consulted the agency throughout the plant's design,
construction and testing.

Write to Jonathan D. Rockoff at Jonathan.Rockoff@wsj.com

Credit: By Jonathan D. Rockoff

Word count: 866
(c) 2015 Dow Jones & Company, Inc. Reproduced with permission of copyright owner.
Further reproduction or distribution is prohibited without permission.

Abstract
TranslateAbstract

Many other industries adopted such a "continuous-manufacturing" approach years ago,

because quality can be checked without interrupting production--with weeks shaved off
production times and operating expenses cut by as much as 50%. [...]recently,
pharmaceutical companies have been stuck making drugs the old-fashioned way, mixing
ingredients in large vats and in separate steps, often at separate plants and with no way to
check for quality until after each step is finished.

Details
Subject

Pharmaceutical industry;
Drugs;
Ingredients

Company / organization

Name:

Vertex Pharmaceuticals Inc

NAICS:

541711;

Name:

BioMarin Pharmaceutical Inc

NAICS:

325414;
Name:

Novartis AG

NAICS:

325412, 325130

Title

Drug Making Breaks Away From Its Old Ways; 'Continuous-Manufacturing' Process Can
Improve Quality Control, Speed Output

Author

Rockoff, Jonathan D

Publication title

Wall Street Journal (Online); New York, N.Y.

Pages

n/a

Publication year

2015

Publication date

Feb 9, 2015

Section

Business

Publisher

Dow Jones & Company Inc

Place of publication

New York, N.Y.

Country of publication

United States, New York, N.Y.

Publication subject

Business And Economics

Source type

Newspapers

Language of publication

English

Document type

News

ProQuest document ID

1652331209

Document URL

https://search.proquest.com/docview/1652331209?accountid=14565

Copyright

(c) 2015 Dow Jones & Company, Inc. Reproduced with permission of copyright owner.
Further reproduction or distribution is prohibited without permission.

Last updated

2017-11-22

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