New pharmaceutical development and business models alike rely on speed-to-market for success. Those able to implement their process first by securing commercial-scale GMP capacity faster than their competitors will have a distinct advantage.

The business of drug development and manufacturing has fundamentally changed. On the one hand, commercializing and manufacturing new, class-leading drugs has become increasingly cost-prohibitive. Globally, most mature markets will continue to increase their per capita drug spending. China’s growth rate, for example, is expected to jump 70% by 2018,1 according to IMS analysis.

Speed-to-Market as the Key to Success

The pharma industry has capitalized on advances in medicine and science with product and process innovation. Companies have reshaped their business models to overcome regulatory and market access hurdles, while at the same time remaining competitive. They have extended the life of their portfolios. They have established operations in emerging markets in order to meet post-patent protection business goals, satisfy shareholder expectations and serve untapped markets. Speed — specifically, speed-to-market — has been and remains the key to success. In order to achieve fastest time-to-market, one must have reliable access to cGMP process capacity, when and where it is needed.

According to PricewaterhouseCooper, drug developers rely on four strategies in order to increase profits: research and development productivity, patent and product extension, marketing and sales initiatives, and manufacturing and supply chain cost-efficiency measures.2 Advances in knowledge and information management have allowed companies to create new products and develop new processes more quickly. However, there are still limitations within the R&D process, particularly with regard to clinical development. In value-based systems, clinical demonstration is clearly becoming more important, and potentially costlier, to drug companies and innovators. That being said, as both human genomics and pharmaceutical science continue to advance, we can anticipate a higher success rate from trials. This means more therapies in less time, which, as a result, will put more pressure on those responsible for delivering manufacturing capacity.

A product’s success depends on a rapid transition to market, which is why achieving full-scale production in less time has many benefits, such as extended patent protection for approved drugs. Likewise, penetrating new markets before the competition can produce a profound and lasting advantage. Manufacturing capability, once perceived as a time-consuming obstacle to initial market penetration, now determines success more than ever before. 

Historically, costs over the life of the product were relatively small when compared to the initial cost of R&D. And so, in tandem with restrictive regulatory expectations, this view prompted many organizations to focus on R&D investment and marketing in order to be more competitive. 

Speed – specifically, speed-to-market – has been and remains the key to success.

But the environment has changed. Now, the ability to field operationally excellent manufacturing capability determines whether or not one can respond effectively to both market opportunity and to the current GMP regulatory climate. Indeed, in a survey conducted at a recent ISPE meeting, pharmaceutical executives indicated that flexibility was the most important characteristic of future manufacturing operations

Consumers are disinclined to pay for poor-performing drugs. In order to improve dose adherence and therapeutic performance, drug makers need faster access to advanced manufacturing capability. Likewise, drug designs have become more complex. In order to manufacture them correctly and compliantly, these newer drugs require a range of current design and engineering techniques, including more sophisticated automation.

To put the situation bluntly, those fastest to market will win, regardless of the product or the market strategy. And getting products on the market quickly requires flexible manufacturing capabilities. However, for many industry players, the capability to engineer and build manufacturing capacity can be extremely challenging. With all the intricacies and complexity involved in building and commissioning full-scale manufacturing capacity, even the most adept organizations are seeking better methodologies in order to acquire what they need within the tighter and tighter time frames.

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As the healthcare product manufacturing industry has evolved, organizations focus more and more on delivering their core services. As a result, they rely on outsourcing, managing risk by fostering deeper, closer relationships with their strategic partners. They do this for two reasons. First, outsourcing allows them to access development and manufacturing expertise. Second, outsourcing allows them to span any gaps in manufacturing capability and accelerate their go-to-market plans. 

We have established that developing flexible, fast and sophisticated manufacturing capabilities is essential to compete and succeed in the current market. For many, the question still remains “how to get there from here?” Constructing, commissioning, achieving full-scale operation and maintaining a GMP manufacturing facility is a complex process. In particular, teams responsible for delivering this capability must successfully integrate [1] the molecule and its process chemistry; [2] the equipment, systems and automation; [3] process control strategy; and [4] human performance elements. Most teams focus on placing an asset in service, fully qualified. But that does not get us to successful GMP operational capability. Instead, teams must engage with many stakeholders, interacting across functional and managerial boundaries to create, share and develop information. Projects of this magnitude are a personnel- and information-management challenge.

A Field Guide to Full-Scale Operations

The recipe for success requires equal parts innovation and experience. Over the past twenty years, Commissioning Agents, Inc. has led the industry in helping our clients to improve the performance and reliability of their processing and manufacturing facilities. We have distilled our two decades of collective wisdom into a standardized method — entitled FIELD BOOK: The Chemistry of Full-Scale Operations — for bringing GMP manufacturing capacity to fruition, from concept to operations. The Commissioning Agents, Inc. platform distills GMP production into five integrated elements (see figure), which outlines the necessary steps to develop successful, cost-effective, high-yield, reliable, efficient and compliant operations.

The FIELD BOOK’s rubric is organized into five well-defined modules to take a product from development to full-scale operations:

  1. Project
  2. Process/Product
  3. Staff
  4. Facility
  5. Quality

The FIELD BOOK’s approach listens to the “Voice of the Product” to determine what a product truly needs from its manufacturing quality system to be reliably produced in a high-yield, high-quality manner. The FIELD BOOK integrates information technologies, staff development and operation design to allow owners to effectively manage and operate full-scale product manufacturing operations in a GMP-regulated industry. Speed-to-market has never been more important to drug owners and developers. Getting to commercial-scale processing the fastest with safe, robust GMP manufacturing is the goal, and the Commissioning Agents, Inc. FIELD BOOK offers the map and the means to achieve it.

References

  1. Most Countries Will Experience an Increase in Pharmaceutical Spending Per Capita by 2018. Rep. IMS Institute for Healthcare Informatics. Web.
  2. From Vision to Decision Pharma 2020. Rep. PWC. Web.