Eye on Excipients: Efficiency Through Judicious Distributor Choices

The pharmaceutical industry is as strict as it comes in terms of demanding quality products and procedures. And rightfully so, because that never-satisfied outlook helps ensure confidence in the efficacy and safety of pharmaceuticals. Because of the “high-maintenance” nature of pharmaceutical manufacturers, many companies that distribute pharma ingredients have shifted their focus to markets whose customers are less demanding and/or address only the basic supply obligations of the pharma sector. 

My company, however, took the opposite approach. In 1993 we opted to focus exclusively on the pharma industry and changed our name to reflect that. It wasn’t a tough call. As a small distributor, we realized that the most promising path to success was to work “where the trees are thin.” That is, we stayed away from market segments where the large generalist chemical distributors worked in favor of serving pharma, where relatively few distributors were dedicated to replicating the industry’s obsession with quality. Pharma customers and specialty suppliers were both eager for supply-chain partners who understood the industry and could navigate through a thicket of regulations to supply pristine raw materials and supply them on demand.

Drawing on many years of experience, here are my thoughts on the key areas where excipient distributors can add value to pharmaceutical manufacturing. 

Quality Starts at the Source

The pharma niche was an obvious choice for us, and the next step was identifying quality-oriented suppliers with a long-term interest in establishing and maintaining a strong presence in pharma. In the early 1990s, most ingredient manufacturers were new to pharma and the term “excipient” was almost a foreign word. At the time, most food-ingredient manufacturers had a small pharma division— just one or two employees— that constantly had to justify its existence to management. It seemed like a lot of work and a big hassle to move such small volumes. Those small divisions, however, generated very high profit margins, and gradually, they started moving toward center stage. The word “excipient” wasn’t so foreign anymore. 

Eventually, we had more than 25 suppliers in our portfolio, each one a world-class excipient manufacturer. We call the portfolio our tool box: It comprises different excipient manufacturers that enable our customers to find whatever material they need to address drug product functionality and efficacy, from R&D to large-scale production. Pharma manufacturers— our customers—welcome a distributor who offers multiple excipients to suit all delivery platforms. This was the first key to our success: choosing suppliers with innovative products who are driven by quality, quick to respond, and flexible. 

Global Connectivity 

The world is forever becoming smaller, and pharma manufacturers operate multiple sites around the globe to serve different markets. That makes consistency in excipient sourcing, suppliers, transparency, and supply-chain security imperative. Yet even today, distribution channels are fragmented and there are too many missing links— even black holes—in supply-chain traceability. This can jeopardize excipient integrity and patient safety, and it explains why pharma manufacturers and excipient suppliers put a high value on working with a distribution partner who can serve their key pharma markets. Product knowledge, technical support, quality service, and sound logistics are what build global supply chain confidence. For those reasons, Mutchler agreed to be acquired in 2016 by IMCD Group’s pharma business unit, which has launched our company from its base in the USA and Puerto Rico into the global market. 

Quality Compliance 

Successful excipient distributors should physically mirror the pharma manufacturers they supply. That is, their facilities should look like their customers’ sites or even better. That includes warehouses and repacking operations that meet GMP requirements; robust procedures that keep pests under control; and inventory that is well managed. It also requires top-notch incoming/shipping, training, waste disposal, carrier/key-supplier compliance, contingency plans, risk management, and safety. There should also be photo libraries that clearly show excipient packaging, labels, and seals to help operators manage discrepancies. 

Distributors are the last filter before a product is delivered to pharma customers, and serious excipient distributors are frequently audited by their customers. Good distributors learn from these audits and elevate their quality standards. They also know and follow the Good Distribution Practices guidelines published by the International Pharmaceutical Excipient Council (IPEC), which are a cornerstone of sound excipient distribution. ExciPact is another important group. It offers a GMP certification scheme used by quality-conscious excipient distributors and others that eliminates the need for pharma manufacturers to audit every supplier. ExciPact certification indicates that a distributor’s practices comply with IPEC’s guidelines and align with ISO 9001:2015 and ISO/IEC 17021-1:2015 requirements. ExciPact certification is becoming an essential global credential for excipient manufacturers and distributors who want to reassure customers they are dedicated to pharma quality. Right now, few excipient distributors have the certification, but it will soon be the norm. We’re in the process of obtaining it. 

Offering Value Beyond What’s Expected 

The future is bright for innovative excipient distributors who make supply chains more efficient. An excipient distributor is, after all, a sales expert for the suppliers it represents and promotes. That means its staff must understand the functionality of all its excipients and their pharma applications. This kind of technical expertise is important when selling to R&D staff and is the best way to be included in new projects. All of the distributor’s sales executives should be trained in pharma formulation, including intensive hands-on training that requires them to formulate and produce tablets, capsules, topical ointments, and other dosage forms. That requires working with suppliers who are willing to convey their technical knowledge—on different applications and formulation troubleshooting—to the distributor’s sales team. It’s the kind of expertise R&D departments welcome. 

Too often, when pharma manufacturers demand added value, all they get is a lower price on the excipients they buy. What they really value, however, is a strategic partner, one who can introduce efficiencies into the supply chain—and ultimately the production process—to make a manufacturing site more competitive. 

Technical Expertise

To bring innovative formulation technologies into our value-added model, we created the position of technical product manager (TPM). TPMs have in-depth formulation experience from working in the R&D departments of pharma manufacturers. Their main role is to train the sales team on all the technical aspects of the products in a suppliers’ portfolio and to develop a high level of technical expertise for the team. This helps create a pipeline of formulation projects that should result in NDA approvals and more business when production volumes grow. TPMs are part of a global team of technical experts placed in key regions around the globe to identify and take advantage of connections with related industry segments. TPMs are based in strategic markets but rely on work done at the main applications lab near Cologne, Germany, which provides suppliers with support to develop new uses and grades of existing excipients, as well as opportunities to find new ones to help deliver innovative therapies. Suppliers and our customers in R&D departments appreciate this added value from their distributor. Though rare today, this model of providing technical resources to the supply chain is likely to spread.

Customization

For years, distributors have studied the pre-production process to learn how to inject value beyond price and logistical efficiencies. What we discovered is that many pharma manufacturers don’t know the true in-house cost of ownership of an excipient, only the delivered per-kilo price. In response, we launched Added Value Services (AVS), a division that supplies production-ready excipients in custom repackaging and weights and that are tailored to allow customers to add the excipients directly to the production hopper. Offering excipients this way was only possible by instituting the same practices our pharma customers use, including operating under strict GMP protocols, keeping batch records, and working in validated cleanrooms. As a result, the distributor can become part of the production process, offering specialty packaging that excipient suppliers maybe cannot. The value comes from eliminating tedious in-house preparation and accelerating cycle times to reach the market faster.

Samples

The rule of thumb is, “There has never been an order for a new excipient without a sample.” Offering samples to R&D customers is imperative for gaining approval for use in production. That’s why excipient distributors must keep ample inhouse samples of all the products in its portfolio. In addition, all samples must have sufficient shelf-life, be correctly labeled, and provide lot traceability via valid certificates of analysis. Most customers request samples in groups of three, each from a separate lot, so variances can be measured. Excipient manufacturers don’t always get this protocol right, which can waste time and the sales opportunity. Excipient distributors can help get it right. 

Furthermore, most samples aren’t packed under GMP conditions. This is done purposely to deter customers or prospective customers from using them in marketed products. Here, too, the distributor can help by repacking bulk excipients into sample sizes under GMP conditions to maintain the product’s integrity. This practice could become the norm for sample packaging. In fact, it could lay the groundwork for automatic dispensing machines: When a request is received, the machine retrieves fresh samples from bulk, weighs them, adds a label, and inserts the required documents into the outer package. Everything could be done as a GMP-compliant, continuous process. 

Conclusion 

The role of excipient distributors is expanding and those that adapt have a bright future as value-added contributors to both pharma manufacturers and excipient suppliers. Both ends of the chain rely on the conduit in the middle. In the future, distributors will have even more influence on what excipients are used in formulations and in providing production efficiencies. Distributors who offer what I’ve described above will become indispensable to pharma manufacturers and excipient suppliers seeking superior service, value, and market reach. T&C