BioPharm International, September 2004

Controlled Environments

BMS or PLC? Controlling the Regulated Environment

By Jeff Bredeson , Ray Benton

If the system is not 21 CFR Part 11-capable or the network configuration is not appropriate, cost is immaterial.

Outsourcing

Overseas Outsourcing: The Advantages of IT Offshoring

By Drew Wright

Life sciences firms haven't exactly been jumping on the offshore outsourcing bandwagon. But faced with unprecedented cost constraints, competitive pressures, and regulatory scrutiny, the industry needs new solutions to its business problems. Some experts think information technology (IT) "offshoring" offers a solid alternative; others question the idea.

Filtration

Optimization, scale-up, and validation ISSUES in FILTRATION of Biopharmaceuticals, Part II

By Anurag S. Rathore, PhD , Alice Wang , Manoj Menon , Jerold Martin , Jennifer Campbell , Elizabeth Goodrich , Frank Riske

Filtration is one of the most commonly used unit operations in the manufacturing of biopharmaceuticals. This is the second part of the fourth article in the "Elements of Biopharmaceutical Production" series. In this second segment, Manoj Menon and Frank Riske present an approach for the development and optimization of a TFF application, followed by a contribution from Jennifer Campbell and Elizabeth Goodrich reviewing key issues involved in validation of a TFF step.

Plant-Made Pharmaceuticals

Chloroplasts: Transforming Biopharmaceutical Manufacturing

By Melinda Mulesky, Ph.D. , Karen K. Oishi, Ph.D. , David Williams, Ph.D.

A 20% TSP-producing cultivar can generate up to 265 pounds of crude recombinant protein per acre.

International BioMarket

French Biotech: A Fast-Growing Industry

Over the last 20 years, France has become a major hub of the European biotechnology sector. The renewed French interest emerged from the perception that progress in biotechnology is good not only for the country's economy but also for the well being of people worldwide and both the private and the public sectors.

Columns and Departments

Editorial—Public Pressure, the Press, Politics, and Profits

By Carol L. Fisher

American patients are more educated about health issues than any prior generation, thanks to the Internet. I read somewhere that doctors, from family physicians to specialists, are amazed at how well prepared their patients are when they show up for an appointment — with documentation in tow after researching conditions, medications, and treatments. So much so that the doctors are stressed out from trying to answer all their questions, complete their exams, and get everyone out the door in the amount of time the insurance companies say is "reasonable."

Regulatory Beat: Washington Seeks New Therapies to Combat Bioterrorism, Cancer, Obesity

By Jill Wechsler

To help speed promising new treatments to market, FDA is streamlining its oversight of oncology therapies, including biotech products.

StreetTalk: Your Cash Ain't Nothing But Trash: Wall Street Not Embracing BioTech IPOs

By Brian O'Connell

The industry entered 2004 with a strong balance sheet — about $16 billion in cash and a wide-open pipeline full of new drugs and products.

Applications: The Disposables Option

By Holly Haughney

Disposable systems only require initial cleaning validation, and ongoing validation activities are typically limited to operator training and routine monitoring.

Final Word: World Firsts From the Double Helix to Therapeutic Cloning

By Alastair Newton

The US will, beyond doubt, remain the world leader in life sciences for the foreseeable future. However, as with other sectors, bioscience — both R&D and business — is increasingly global. For US researchers and business leaders alike, it makes increasing sense to look beyond the shores of America for both expertise and profit-making opportunities. For many, the principal partner of choice has been — and will remain — the United Kingdom. There are sound reasons for this.