Nice Insight is in conversation with Oskar Gold, Senior Vice President Key Account Management and Marketing/Corporate Communications at Vetter Pharma International, a global leader in the fill-finish of aseptically prefilled syringe systems, cartridges and vials, about how outsourced supply of such services can help companies of all sizes.
Flexibility, responsiveness and operational excellence are increasingly being demanded by drug developers. The challenge faced by companies like Vetter Pharma International is to deliver these to customers. Oskar Gold, Senior Vice President Key Account Management and Marketing/Corporate Communications, says that Vetter believes that partnership is always the key to success, with operational excellence being decisive in both the development and commercial phases.
“Particularly in the early drug development phases, a number of issues that can affect the entire development project scope can arise and thus flexibility is critical,” Gold says. “Also, it is important that a sponsor and service provider with a common target in mind act as one to successfully perform a drug development project that can get the drug on the market as fast as possible, where it can improve or even save patient lives.”
Increasingly, contract development and manufacturing organizations (CDMOs) like Vetter are acting as the interface between small biotech firms and large drug manufacturers. There is a variety of reasons for this, in Gold’s opinion.
“By definition, a CDMO has long-term experience with a variety of complex compounds and knowledge of most recent regulatory guidelines. CDMOs have also installed targeted development services portfolios either within or close to the markets where innovation is happening. Thus, a leading CDMO can provide the appropriate capacities and services across markets.”
A “solution provider” like this can help sponsors of all sizes to align their requirements and bridge gaps, Gold contends. For smaller biotechs, partnering with one can offer the support needed for faster and more efficient drug development, adding critical value from the earliest stages via a combination of efficiency, long-term thinking, high quality and safety. Larger companies can benefit from this approach at a later stage when acquiring a drug substance or, indeed, the small biotech.
It is important that a sponsor and service provider with a common target in mind act as one to successfully perform a drug development project that can get the drug on the market as fast as possible, where it can improve or even save patient lives.
There are many who say that there is currently an excess of fill-finish capacity. Based on its own experience in recent months, including dialogue with customers, Vetter does not entirely agree. Its manufacturing sites in Germany and the U.S. are experiencing continuous short-, medium- and long-term demand for these services.
However, the company has indeed seen a shortage of fill-finish capacities for certain types of delivery systems and containers, such as lyophilized vials. For this reason, it announced at the end of 2015 a strategy to invest significantly in the expansion and upgrading of its manufacturing facilities over about ten years, preparing these facilities for the expected future requests and the associated need for high-quality drug product manufacturing.
Gold points to a PharmSource analysis that contains data from the clinicaltrials.gov website. This shows that phase I and II trial starts by emerging (bio-)pharmaceutical companies were 55% higher last year than five years before.
“Because such companies are often highly dependent on external service providers for nearly all of their process development, formulation and manufacturing requirements, we see the future of CDMOs as being in very good shape, as long as they stay ahead of regulatory requirements, as well as performing in a committed and dedicated way,” he says.
Vetter continues to acquire or move strategically to acquire processing capacity in the U.S. near Chicago. This reflects the important role the U.S. market plays for the pharmaceutical industry in general and for Vetter in particular. Approximately two-thirds of all drug development projects take place in the U.S. and more than half of Vetter’s customers are headquartered there; the company currently manufactures about 50 customer products with FDA approval.
This is one of the reasons behind Vetter’s existing small-scale clinical manufacturing facility at the Illinois Science+Technology Park in Skokie, which was its first such facility in the U.S. The ongoing purchase plans would complement rather than duplicate this facility.
At the manufacturing level, where the actual projects are completed, trust-based and well-managed relationships provide the needed intellectual fuel necessary for a successful project outcome while helping to optimize costs and improve efficiencies.
“In fact, several of our customers have expressed their desire that we offer commercial manufacturing opportunities in both the U.S. and Europe. Thus, the current project supports our ‘ability to act’ preparations that put us in the position to offer our customer base greater flexibility in global manufacturing for the future, due to an increase in geographical manufacturing opportunities,” Gold adds.
Vetter recently was honored by AbbVie, receiving its highest Supplier of the Year “Triumph” award. Last year, it also won the WorldStar Award for its syringe closure system Vetter-Ject and the 2016 CMO Leadership Award in the four categories of quality, capabilities, expertise and compatibility.
While agreeing that winning any recognized award is always an honor, Gold says that the AbbVie Triumph award is particularly significant “since it recognizes past and present efforts on behalf of one of our most important customers. With this award, which is granted within a field of more than 1,000 contractors, our customer acknowledges its top performing contract suppliers for efforts that consistently add measurable value and regularly exceed best-in-class performance for the company and the patients that rely on their products.”
For Vetter, he adds, this is particularly significant since the practice of managing customer relations has never been more important to CDMOs than it is today. Factors — including the high value of drug substances, escalating costs of development, product safety and security of supply in a complex and globalized world, as well as an increased competition — have added new intricacies to the business.
“At the manufacturing level, where the actual projects are completed, trust-based and well-managed relationships provide the needed intellectual fuel necessary for a successful project outcome while helping to optimize costs and improve efficiencies,” he concludes.
