Special edition: Outsourcing

Collaborate or die: Inside a contract manufacturing giant

By Shane STARLING contact

- Last updated on GMT

Peter Zambetti: "We are also at the regulatory table, providing a critical industry voice to create solutions that affect manufacturer customers and consumers locally and globally."
Peter Zambetti: "We are also at the regulatory table, providing a critical industry voice to create solutions that affect manufacturer customers and consumers locally and globally."

Related tags: Dietary supplement

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Capsugel director of global business development for health and nutrition, Peter Zambetti, tells NutraIngredients why collaboration is key in business, in regulation and more...

What makes for a good relationship?

Collaboration. It is our guiding principle for building strong relationships with customers, suppliers and other types of partners. We begin by listening to develop a deep understanding about our customer’s challenges. We then share a variety of solutions by bringing together formulation and encapsulation science and engineering. By partnering with our customers we arrive at a productive outcome that advances their business goals.

Importantly we have a dedicated team of experts for health and nutrition customers. Our experts have a deep knowledge of the industry and can share insights on challenges specific to this sector including speed to market, regulatory guidance, health claim labelling and more.

Whether it is providing a technology to improve the bioavailability of a product, formulation expertise for our portfolio of vegetarian capsules or commercial manufacturing know-how for lipid-based nutritionals, Capsugel collaborates with its customers to apply the right solution across the health and nutrition sector.

What services do you offer?

Capsugel is a global leader in delivering high-quality, innovative dosage forms and solutions. Our science driven technology selection process and intellectual property differentiates us from traditional CRO, CMO and CDMO models. We deliver flexible, real time solutions across the entire span of dosage form products from design through development and commercial manufacturing. 

Our Hard Capsule business offers customers the broadest portfolio of gelatin, vegetarian, and other specialized capsule technologies. Our Dosage Form Solutions business utilizes an array of proprietary technologies and specialized manufacturing capabilities to solve customers’ most pressing product development challenges, including bioavailability enhancement, modified release, abuse deterrence, biotherapeutic processing, and inhalation formulation. 

Further, with feet on the ground around the world we can capitalise on trends as they happen and quite often we are ahead of trends before they become mainstream. To validate what we see in the market Capsugel conducts extensive consumer research on buying habits and consumer preferences.

How do changing regulations affect partnerships?

Stronger regulatory requirements and Good Manufacturing Practices (GMPs) are creating new baselines for the health and nutrition industry, requiring suppliers to improve their practices and comply with more stringent standards.

Consumers are playing a vital role in driving this focus on quality by demanding nutritionals sourced with the highest quality ingredients. In this environment it is no longer enough to formulate products to meet basic regulatory requirements. Our industry needs to recognise the widespread benefits of advocating for tighter quality controls which benefit our consumers and the industry in general.

quality management

In markets like the US and Europe we know consumers are looking for more natural choices that eliminate additives from their favourite products, heading towards a clean label approach. Using a capsule instead of a tablet already allows the manufacturer to remove many of the ingredients consumers are trying to stay away from. In the food industry, Kraft just announced they were removing artificial colors from their infamous 'Macaroni & Cheese' due to consumer concerns.

According to a customer survey conducted onsite at Vitafoods Europe 2014, the industry agrees. 85% of customers surveyed declared that product quality and safety was their primary concern. We expect a similar level of concern from our survey conducted this year.

Capsugel takes an active role in helping set global standards and sponsoring quality initiatives that impact the health and nutrition industry. We are also at the regulatory table, providing a critical industry voice to create solutions that affect manufacturer customers and consumers locally and globally.

What of the rise of GMPs?

pills_medical_joint_venture_iStockfree

Good Manufacturing Practices (GMPs) are an important benchmark for our industry and have become increasingly relevant in the US, European Union and the ASEAN (Association of South East Asian Nations) region. The US and EU have issued enforceable GMPs covering food, food supplements and other products.

ASEAN regulators have also implemented requirements for manufacturing standards and are currently working to harmonise health and nutrition standards, which means safer food supplement products for consumers.  

What about rogue players?

Companies that are blatantly putting substandard nutritional products on the market need to be held accountable. The good news is that trade groups are aligned in trying to address this important issue. When I served as chairman of IADSA (International Association of Dietary Supplement Associations) from 2010-2014, I worked closely to educate regulators on the importance of strong regulation frameworks that are effective and enforceable.

How is Europe progressing versus other parts of the world?

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After a long campaign to drive interest and buy-in on Good Manufacturing Practices (GMPs), the EU is now implementing tougher regulatory standards. The European Commission recently published guidelines for GMP excipients. The move allows higher quality products to be imported into the EU.

While having access to safe products is of utmost importance, at the same time, health and nutrition supplements should not have the same strict regulations as pharmaceutical drugs. Unnecessary regulations may contribute to a standstill in innovation and growth.   

Overall, there is still a long way to go in Europe. The future 'desired state' for the EU would be an enabling regulatory strategy that keeps pace with innovation and with consumer demand.   

What happens when something goes wrong in the manufacturing process?

Capsugel has robust processes in place to mitigate potential issues with the development and manufacturing of our products. The company performs 'mock' recalls to ensure we are prepared should there ever be a situation where we need to take action. However, by doing things right the first time, we hope to mitigate that potential.

Would you ever refuse a client? On which grounds?

We consider ourselves easy to do business with and try to work with most customers to find a solution. We want to do business with customers who align with our vision and bring the best quality products to market at fair prices while adding value to the process.

Related topics: Manufacturers, Supplements

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