EXECUTIVE INTERVIEW - Sanner Group: Building a Suite of World-Leading Services for its Customers

Shortly after Sanner Group announced its acquisition of Gilero, the medical device design, developer, and manufacturer based in Durham, NC, Drug Development & Delivery recently interviewed Chris Gilmor, Vice President of Sales, Sanner of America, to discover how its Advance with Agility™ program helps its partners achieve faster development times and reduce time to market, and how the company embeds sustainable practices into its global business.

Q: To set the scene for our readers, can you please describe Sanner’s business?

A: Sanner GmbH was founded in 1894, and we are now known as a global market leader for desiccant closures and effervescent tablet packaging. As the business has grown, most recently with the acquisition of Springboard Pro in Cambridge, UK, we have become a sought-after provider of customized solutions in the areas of medical devices and diagnostics, pharmaceuticals, and consumer healthcare.

Q: I believe most readers would agree our industry has seen a lot of disruption, yet development pipelines are healthy and there’s a lot of innovation. How has your business adapted?

A: Innovation has always, and will continue to be, the hallmark of this industry. It is the responsibility of companies such as Sanner to evolve accordingly by augmenting its products and services to meet new market needs. During the past decade, specifically between 2011 and 2016, the pharmaceutical industry experienced the “patent cliff” with the largest number of patented drug product expirations in history. This greatly changed the competitive landscape between innovators and generics for oral solid dose (OSD) delivery. Concurrently, the industry embraced the rise of innovative biologic therapeutics presented in small-volume, high-value, parenteral formats that have different packaging, dosing, and administration requirements. Sanner is uniquely positioned to support companies across these and other routes of administration with our comprehensive contract design services and manufactured solutions.

Q: How has Sanner responded to those demands?

A: Though market share has changed, from 2017 to 2022, 182 of the 293 (close to 62%) of the new chemical entities approved by the FDA were small molecule OSD drugs. Furthermore, small molecule OSD formulations still represent about 38% of the drugs in Phase 3 clinical trials, many of which will be susceptible to moisture mediated chemical and/or physical degradation requiring the use of a desiccant with primary packaging to ensure drug safety and efficacy.

Historically drug manufacturers have used probe stability studies to determine the type and amount of desiccant required to ensure product shelf-life required by global regulatory agencies. These probe stability studies, designed as a matrix of various desiccant types, amounts, and packaging materials conducted under real time testing conditions can take between 6 and 12 months, depending on the number of iterations required. With each stability test estimated to cost upward of $225,000, this approach costs significant time, money, and testing waste.

Sanner provides a Quality-by-Design (QbD) approach for our customers in our Advance with Agility value proposition that combines our moisture management prediction program, Atmo Guard System®, with industry recognized predictive stability modeling by FreeThink Technologies’ ASAPprime®. The Atmo Guard System evaluates the primary drug package with or without built-in desiccant to USP <671> moisture testing standards at 23°C/75% RH, thereby characterizing all aspects of moisture ingress for a given packaging design (ie, assembly joints, interference fit between cap and bottle). These results, when used with ASAPprime and empirical measurements (adsorption/desorption isotherms) on a unique drug product formulation, elucidate stability outcomes for the drug product and proposed packaging configuration modelled. This approach enables drug manufacturers to quickly and correctly select successful packaging during Phase 2B clinical trials, reducing or eliminating the need for long and costly probe stability testing. Reducing development time provides innovators a shorter commercialization timeline, allowing earlier revenue recognition for new products while providing a competitive edge in generic industry where the US first-to-file advantage provides the successful company with a 6-month exclusivity window in which they can recognize upward of 60% of their profits for that drug product alone.

Our Advance with Agility program doesn’t end with the faster determination of the required stability solution, but provides consultative guidance on the designation of a commercially available desiccant product, the design of a custom, built-in, desiccant solution if requested, through to dispensing guidance for commercial packaging operations to optimize packaging uptime with unparalleled quality and efficiency.

Companies not only value Sanner’s understanding of primary packaging design, materials of construction, moisture ingress, sorbent technology, and packaging operations, but the consultative approach in which we ensure all key stakeholders from formulation, R&D, package engineering, packaging operations, procurement, quality, and regulatory are engaged so all needs are addressed with efficiency and effectiveness.

Advance with Agility is our promise to our customers to provide faster development, packaging changes, and time to market.

Q: As a provider of moisture control solutions for medical devices, diagnostics, and pharmaceutical products, does Sanner find itself at odds with environmental considerations?

A: The primary purpose of healthcare packaging is to preserve and protect products, ensuring they are safe and effective when used. As OSD formats remain a core focus, both physical and chemical stability challenges will persist making the elimination of plastics such as HDPE and PVC in primary packaging presentations with related desiccant use difficult to avoid.

We recognize there is a move toward sustainability across the board in the pharmaceutical industry, including both prescription and OTC products, with a significant rise in attention to the amount of plastic waste and the impact it is having on our global environment and public health. While the elimination of plastic in healthcare packaging is not readily viable, alternate sustainable solutions exist that include material selection, but forward-thinking design considerations and regionalization of supply chains as customers aim to minimize their carbon footprint and de-risk supply chain risk that the recent COVID-19 pandemic highlighted.

Sanner offers BioBase®, the first package designed for effervescent tablets that is made from renewable and responsibly sourced raw materials. BioBase is nearly free of petroleum-based fossil raw materials, made from 94% plant-based material and responsibly sourced biopolymers, offering a substantially lower carbon footprint than the traditionally used polyethylene or polypropylene alternatives. BioBase has been proven to run efficiently on existing filling and packaging lines, supporting traditional labels, off-set print or in-mold labeling applications while being suitable for common recycling streams. Most impressive is that the BioBase solution offers improved moisture barrier, up to 40% longer shelf-life, than the traditional polypropylene tubes.

The cornerstone of our product development process is based around an understanding of, and interactions between resources, material efficiency, recyclability, and the design of biobased packaging options. Product development is governed by our IDP-Process, or Idea-Design-Product, which carefully evaluates all stages from the initial idea through to finished product by looking at: concept, design, prototyping, industrialization, commercialization, and life-cycle management. This stage-gate process empowers our team to ensure our cornerstone mandates are incorporated into every product we design at each stage of the development for our customers.

Sanner is committed to sustainability in a more comprehensive manner than the few examples I have provided here. We publish an annual sustainability report, which is available on our website. Of particular interest, Sanner has recently completed moving into our new flagship state-of-the-art facility located in the Green MedTech Park of Bensheim, Germany.

Q: What’s next for Sanner?

 A: Sanner Group’s goal is to focus on building a suite of world leading services for its customers across the drug delivery, diagnostic, nutraceutical, and medtech device sectors. The recent acquisition of Gilero in Durham, and that of Springboard Pro, further position the business as a leading provider of end-to-end services across drug delivery, diagnostics, and medtech device sectors.

As we look to the future, Sanner Group will have a significant local presence in the North America CDMO industry anchored by Gilero and our new US manufacturing site in Greensboro, NC. This new facility, (60,500 square feet/5,620 square meters), on track to commence commercial production this summer (2025) will also support our current and evolving product portfolio in the pharmaceutical packaging and moisture management sector. Our investment in the North American market is an indication of Sanner’s commitment to the industry by providing local, in-market, design, engineering, regulatory, quality, sales, and manufacturing support and expands our global manufacturing presence with sites currently in Germany, France, Hungary, and China.

Our US-based manufacturing site also addresses the comment I made previously regarding the regionalization of supply chains. Companies are increasingly aware of the cost of transporting goods, particular over great distances from one continent to another. This problem can be further exacerbated based on the type of product being transported. Our desiccant canisters have a high packaging density providing improved economics and carbon footprint over effervescent tubes that are akin to shipping “air”. Our US site will provide our customers the ability to source key packaging solutions for their global manufacturing and packaging sites, greatly reducing their carbon footprint from transportation. A network that includes multiple manufacturing sites also fundamentally de-risks supply chain concerns. Should a disruption occur in one facility, our customers know we can continue to support their needs from another facility. The future will surely be an exciting time for Sanner and our customers.