June 15, 2009 (Vol. 29, No. 12)

As with Any High-End Purveyor, a Highly Satisfactory Customer Experience Remains Key

The word boutique isn’t exactly a term you hear often in the biopharmaceutical world. Most people associate a boutique with up-market clothes, but the word actually comes from botica, which is French for apothecary or pharmacy.

A group of specialty contract manufacturing organizations (CMOs) are now calling themselves boutique contract manufacturers. In the world of biopharmaceuticals, boutique implies a high level of sophistication, close attention to customer demands, and, in the boutique tradition, an offering of up-market, high-quality products and services. In fact, the customer experience when working with a true boutique biopharmaceutical CMO is no different than you’d expect working with a boutique investment house or a boutique winery.

CMOs have flourished in an age of outsourcing. They offer turn-key services across a wide range of biopharmaceutical research and development disciplines, from development and bench research services, to at-scale manufacturing and global regulatory guidance.

One reason they have flourished is that they represent risk-avoidance and cost-avoidance opportunities, sometimes at dramatic levels, to the capital expenditure you would otherwise sink into various product-development and manufacturing enterprises.

That “cap-ex” ranges from human resource and facilities costs to equipment, as well as the development and retention of expertise. There is also the cost of time to consider, whether it be time to ramp up development, time-to-market, or simply the time it takes to optimize the opportunity to actualize, and eventually commercialize, a beneficial therapy.

In biopharmaceutical development and cGMP production, outsourcing isn’t the dirty word it may be in old-line manufacturing. Indeed, outsourcing to a CMO is often the most efficient way to get beneficial biopharmaceutical products, from vaccines to biosimilars, launched rapidly into the market and at a global scale.

A boutique CMO’s greatest value is often delivered at the earliest stage of development, where the CMO’s knowledge and collaboration can help clients recognize the full future value of their biopharmaceutical product—a future value that a narrow insider’s view may have underestimated or otherwise missed.

Additionally, although a traditional CMO may offer a broad range of manufacturing services, a boutique CMO will also add value to manufacturing by providing consultancy and regulatory services. Finally, a boutique CMO will offer immediate access to fully functional, highly specialized expert services and a flexibility that is hard to achieve in traditional corporate structures.

For example, a CMO can provide highly proficient project management (a baseline ability of any true boutique CMO), with an expert outsider’s eye to help identify problems, as well as guide and redirect programs.

We all know that biopharmaceutical development is a complex and fluid  endeavor. But we also know that the endeavor must be focused on efficient use of resources and time-to-market. When a boutique CMO brings expertise to the endeavor, it helps clients focus holistically on product development and not just process development.

Boutique CMOs begin with the end in mind, anticipate issues early on, and offer the objectivity and inventiveness to deliver stage-appropriate expertise and processes that are scalable, transferable, and economically sustainable over the long term.

A boutique CMO’s greatest value is often delivered at the earliest stage of development where the CMO’s knowledge can help clients recognize the full future value of a biopharmaceutical product.

Roger Lias, Ph.D. ([email protected]), is president and group commercial director of Eden Biodesign.
Web: www.edenbiodesign.com.

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