September Supplement From the Editor

S. Anne Montgomery

September 15, 2016

4 Min Read

SAM-straighton_1-240x300.jpgWhen it comes to outsourcing, I sometimes worry that most of what can be said already has been. How many times do we need to focus on communication issues, which are still an essential element behind successful contract services relationships? As with so many subjects we cover, familiar outsourcing terminology can lead to the false assumption that an industry segment or technical process is pretty much the same as always. After all, speed and efficiency and cost-effectiveness have been goals for a long time — especially since the turn of the century.

Contract service providers always have been at the forefront of manufacturing and facility advances. They championed the first wave of multiproduct facilities back in the early- to mid-1990s, when regulations made those a viable choice. They were early embracers of single-use technologies and have participated in changing the vision of what a modern facility can look like. They provide special insights into the security of complex supply chains, contamination control, and regulatory nuances. And as new technologies advance, requiring different approaches to development and manufacturing, contract service providers are well positioned to develop protocols and in-house expertise to work with clients in developing biosimilars, antibody–drug conjugates (ADCs), recombinant vaccines, and advanced therapeutics.

This special issue’s table of contents may look a bit sparse, but that is misleading: Seldom have I seen authors delve into a topic’s current state-of-the-art as well as the authors here have done. And our two articles developed from roundtable transcripts are packed with forward-looking, complementary insights. Key topics in this issue are capacity predictions, the challenge of preparing products for multiple regions, the influence of advanced and emerging therapies on service offerings, the incorporation of new platforms and analytical methods, and the continuing exploration of disposable technologies (and how they, among other tools, are advancing progress toward continuous operations). A topic raised in one roundtable that we’ve not touched on much previously is serialization: What tools are available for tracking materials across a supply chain?

Capacity: Early this century, many industry experts were concerned about having available manufacturing space and contractors. As titers improved and product lots became smaller, and as single-use equipment could be stacked (or as one roundtable participant puts it, “daisy-chained”), much of the threatened capacity crunch has passed us by without incident. But now it is clear that the issue has reemerged for contract developers and manufacturers. Connected to that is, of course, the maintenance of global supply chains and the pressure to react quickly to local health crises anywhere in the world.

Specialized Services: At the same time, when we talk about capacity, the assumption is no longer that most products will be monoclonal antibodies (MAbs). These days, a contract service provider faces critical decisions about venturing outside the familiar and into the special needs of clients that need help with biosimilar creation and ADCs, bispecific antibodies, DNA/recombinant vaccines, cell/gene therapies (and who knows what else). These modalities create new challenges — especially because a contract ADC program “essentially is the equivalent of four or five CMC programs,” as one roundtable speaker puts it. Another tells us that “patient populations might be relatively small for cell and gene therapies,” but for ADCs “the market could be as large as or even larger than that for antibodies.” These experts have made a good case for consideration of emerging product types and support services needed. Another tells us that capacity is still very limited on the cell therapy and gene therapy side. “So either established players must invest more, or newer players must come into this industry. It’s very important to support future growth.”

Consolidation and Scope of Services: What type of contract manufacturer will you be most comfortable working with? Some roundtable participants say we’ll see more consolidation. But one speaker notes that sponsors also have a choice between working with large contract manufacturing organizations (CMOs) or smaller, mid-sized, nonconsolidated companies that may feel “more approachable” to some clients. To help support such choices, author Franco Negron defines a number of outsourcing service models — variations on the theme. Which one will be right for you? Perhaps these discussions will help you sort out some of those decisions for your own company.

Training and Expertise: With new areas of interest come increased needs for training and building expertise — especially in the ADC arena, for which both small- and large-molecule expertise are key to a successful campaign. BPI will focus on training practices this fall and winter; it’s a topic in which we’re especially interested. Hiring, training, and retention issues are always critical. They are essential to the sustainability of your business practices and the importance of reinforcing quality and control standards throughout a product’s lifecycle.

One speaker says the business is facing “a war for talent.” In this job-hunter’s market, people with the necessary knowledge and skills have many opportunities. Sponsors and CMOs are potentially competing with each other for talent.

I hope the insights presented here will provide both interesting reading and information that will help you plan your strategies for the years ahead.


S. Anne Montgomery, Editor in Chief

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