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Small Scale Registers Big Growth

Mon, 06/25/2012 - 8:11am
Jeff Reinke, Editorial Director

Based out of Ravensburg, Germany, Vetter is a large, global player in the pharmaceuticals contract manufacturing marketplace. Specializing in the aseptic filling of syringes, cartridges and vials, the company employs over 2,800 around the world and generates over $400 million in annual sales. Its three German plants offer 14 cleanrooms for filling complicated hormones, antibodies and more. Additionally, sales have almost tripled over the last 10 years as the company has added more than 1,300 employees.

What’s interesting is that while this type of growth can typically be associated almost exclusively with larger volumes and higher production quantities, this has not been the case for Vetter. Although the company’s contract manufacturing business has also grown, much of the credit for Vetter’s recent surge can be credited, both directly and indirectly, to the company’s Development Services branch. This sector provides support from preclinical development and other processes leading up to mass production. 

According to John Moore, a key account manager out of the company’s Skokie, IL location, Vetter is one of the larger companies to undertake early phase development. “Some try it and find out that they’re just not set up for early phase work,” he offers. “There’s a lot of R&D and lab work for a company to partake in without a guarantee that it will translate to production. So while some CMOs try to do it, having a dedicated focus on it like Vetter does is an advantage,” he states.

Sweet Home, Chicago

As Moore alluded to, it takes significant investments, and confidence in those investments, for clinical development services to become a viable business. Showcasing Vetter’s confidence in their Development Services arm is the recently opened facility in Skokie, IL – about 15 miles northwest of Chicago. This location focuses on clinical stages and early phase manufacturing, working with biotech firms from preclinical development through phase II. The Chicago facility then provides seamless product transfer to Vetter’s large-scale manufacturing facilities in Europe for phase III and commercial manufacturing.

vetter1

Vetter´s Chicago facility prepares materials, handles sterile filtration and
automated lyophilization, as well as visual inspection and testing.

When working in this capacity Vetter prepares materials, handles sterile filtration and automated lyophilization, as well as visual inspection and testing.

Intended for liquid fills, one cleanroom houses a flexible semi-automated filling unit. The system can fill a variety of packaging materials – syringes, cartridges and vials – with a capacity of up to 500 units per batch.

In a second cleanroom Vetter’s automated vial filler, designed specifically for early clinical-stage, high-value biopharmaceuticals, can run up to 10,000 liquid or 6,000 lyophilized vials per batch. While usually much smaller, due to the amount of work and related expense that is characteristic of these clinical materials, fill volumes range from 0.1 to 23 mL. A third cleanroom will expand current operations and provide filling of pre-sterilized syringes. The API comes from the biotech customer.

Working in unison with the other Development Services operation in Germany, the 27,000 square foot structure, which had been empty since 2003, was completely gutted and customized for the intensive laboratory and small scale production necessary for development work. This included implementing new microbiology and chemical analysis labs for in-process and release testing as well as compound-specific testing.

“Chicago made sense for a couple of reasons,” states Moore. “Its central location and proximity to prospective and current customers needing clinical studies makes it ideal.”

Additional investments included specialized filling equipment housed in three Class 100/10,000 area cleanrooms that were constructed to handle the comparatively small batches being produced. All filling units are integrated in a RABS (restricted access barrier system), which mitigates risk of contamination by minimizing human contact with products during manufacture.

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All filling units are integrated in a RABS
restricted access barrier system), which mitigates
risk of contamination by minimizing human
contact with products during manufacture. 

All of the product contact equipment is of the single-use variety, due to the nature of these compounds. Disposing of everything that comes in contact with them has proven to cut lead times, provide better flexibility and save on cleaning costs. 

With typically smaller amounts actually being produced, minimizing line losses is key. “In high-value biologics – every drop counts,” states Moore. “The amount required to fill a water bottle might be the end result of three to five years of development work and several million dollars. So the key to Development Services’ success has been the ability to work quickly and provide our customers with more flexibility. This type of work demands more prep work and more follow-up because you’re working with unproven and highly complex compounds.”

With the developmentally-focused investments Vetter has made, they’re uniquely positioned to work with several different types of customers. Working with biologics companies to prove the effectiveness of a product, then supporting customers to get it through the necessary approval process and establish its commercial viability has allowed Vetter to gain tremendous credibility throughout the industry.

Their track record and focus on quality make the clinical development support they provide very attractive – opening doors for customers to continuing the relationship with Vetter when it comes to mass production.

“Our experience allows us to catch problems in early phases that could lead to more significant issues during large-scale production and patient usage,” offers Moore. Given the company’s extensive history as a CMO, Vetter is also able to keep the method of delivery in focus throughout the process. “We know that a product’s ease of use will play a big part in its commercial success,” Moore adds.

vetter3

Vetter’s automated vial filler can run up to 10,000 liquid or 6,000 lyophilized
vials per batch.

This intuitive knowledge comes into play during multiple phases of the development process. “Vetter understands customer goals and standards because of all of our relationships as both a development services provider and fill and finish partner,” states Moore. “We’re also very honest with customers. We tell them about the problems we’re seeing based on that experience. The end result is an environment where information is more easily shared, and as a result of all those things, we see a lot of return business,” he states.

Quality Over Quantity

While every manufacturer likes to talk in great detail about quality, Vetter looks to demonstrate this focus throughout their operations. Given the small, yet crucial amount often produced and filled, Moore is quick to point out how vitally important attention to detail really is.

“Our employees understand the SOPs that we’ve put in place and KPIs (key performance indicators) are also shared with the customer in streamlining the whole process. Additionally, having a number of operational experts in numerous areas allows us to drill down in dealing with specific product details and the obstacles they can present,” he states.

Other quality assurance practices include regular cGMP (current good manufacturing practices) audits. The genesis for these audits could be customers, regulatory requests or internal continuous improvement strategies. The company has also turned to in-line checkweighing investments and Class 100 equipment to perform filling accuracy. A mistake here, especially due to the smaller quantities involved, could tarnish years of work and millions of dollars in development studies, not to mention the loss of potential business. 

vetter4

The facility is customized for intensive lab and
small-scale production work.

“One of the reasons for our growth has been adapting to the changing face of the pharmaceutical marketplace,” offers Moore. “It used to be Big Pharma handling all phases of development and production. Now, biotech firms handle up to Phase II and then Big Pharma jumps in so they don’t have to allocate so many resources to products that might not be successful.

“That’s one of the benefits we can offer. Biotech demands a lot of preparation resources, so we’re always searching for that balance between what’s needed and what would be nice. This is where our experience plays such a key role. We can learn from what worked before and what didn’t in helping the current customer set their priorities and make quicker decisions."

“Speed is so important because the biotech customer is often looking to sell to Big Pharma. In order to capitalize on all the pre-commercialization work they’ve done, they need to be the first one ready to make the deal,” states Moore.

Ideally Big Pharma gets a product that’s been highly scrutinized, developed with rigid quality assurance practices, and made commercially available with a user-friendly delivery method. It’s a formula that has proven successful for both Vetter and their biotech customers.

Looking ahead, Moore feels the vaccine and high-value biologics sector still continue to be a big growing business segment. “Perhaps the biggest opportunity for us lies simply in supporting more biotech companies. The more people we work with at these clinical states, the more innovative products we can help develop,” states Moore.

At the end of the day Vetter has been able to produce better services via processes that are constantly scrutinized and targeted for improvement. Paying attention to all the little things has proven to be a big reason for Vetter’s current success, as it will in a future that will place even greater demands on CDMOs from a number of avenues. Being able to respond quickly, with high-quality and at the same time cost-effective procedures and embedded flexibility in handling various types of compounds will be key for everyone, including Vetter.

 

 

 

  

 

 

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