CASE STUDY

Roquette Pharma opens pharmaceutical innovation facility in Pennsylvania, US

The facility complements the companys current pharma innovation centres in France and Singapore.

Roquette Pharma has inaugurated its new Pharmaceutical Innovation Center in Pennsylvania, US, with an investment of $25m.

Situated at the hub of the countrys north-eastern pharmaceutical corridor, the new facility is staffed by research, application and formulation specialists.

The facility complements the companys current pharma innovation centres in France and Singapore and intends to improve the patient experience with modern oral dosage forms.

It also aims to contribute to the pharmaceutical sector by facilitating cross-industry partnerships and research-based product development.

The centre will primarily offer expert training and troubleshooting.

In the first phase of its training workshops, the Pharmaceutical Innovation Center plans to develop a range of excipients [inactive substances that serve as the vehicle or medium for a drug or other active substance] for controlled release dosage forms, improving their bioavailability, along with formulating orally dispersible and chewable tablets.

The centre will also organise manufacturing-based seminars on topics such as improving wet/dry granulation procedures and approaches for continuous manufacturing.

The facility allows both clients and partners of Roquette to use improved technologies, including an improved research and development (R&D) continuous manufacturing simulator, a compaction simulator, a hot-melt extruder and advanced dissolution and particle size testing (laser diffraction).

It also has granulation, blending and coating equipment and high-performance liquid chromatography analysis capabilities.

Roquette has appointed a new team of research scientists and formulation experts to offer guidance to the facility and to the companys global pharmaceutical R&D activities.

The team is led by Dr Vinod Tuliani, who will look after Roquettes long-term scientific strategy and its execution across the firms pharma sciences unit.

Roquette Pharmaceutical Solutions vice-president Paul Smaltz stated: Todays grand opening feels like the start of something special for Roquette.

With its strategic location in one of the worlds top pharma-producing regions, the new site will unlock even greater opportunities for closer collaboration with our customers in the US and provide a beacon of best practice training and advice to our teams across the globe.

About Roquette

Roquette is a family-owned global leader in plant-based ingredients, a pioneer of plant proteins and a leading provider of pharmaceutical excipients. Founded in 1933, the company currently operates in more than 100 countries, has a turnover of around 5 billion euros, and employs more than 8,000 people worldwide.

Life and nature have been our sources of inspiration for decades. All our raw materials are of natural origin. From them, we enable a whole new plant protein cuisine; we offer pharmaceutical solutions that play a key role in medical treatments; and we develop innovative ingredients for food, nutrition and health markets. We truly unlock the potential of nature to improve, cure and save lives.

Thanks to a constant drive for innovation and a long-term vision, we are committed to improving the well-being of people all over the world. We put sustainable development at the heart of our concerns, while taking care of resources and territories. We are determined to create a better and healthier future for all generations.

Roquette is organized into six different divisions:

BioPharma: a leader in providing carbohydrates for cell culture, and developing novel technology for protein stabilization.

Pharma & Neutraceuticals: helps save and sustain lives as a trusted supplier of excipients and active pharmaceutical ingredients.

Cosmetics: offers innovative, high performing and sustainable raw materials to the Cosmetics market.

Food & Nutrition: gives consumers the food they want and can feel good about: not just tasty but nutritious and friendly, too.

Animal Nutrition: offers innovative plant-based solutions to meet the needs of your customers.

Industrial Markets: provides high performing, innovative and sustainable plant-based solutions for industrial customers.

The divisions produce nearly 150 unique product, based on proprietary formulation and manufacturing techniques, sold globally to over 5,000 different customers.

Headquartered in France, Roquette has physical presence in 27 countries either through sales offices, production sites, or R&D activities. The 10 R&D laboratories are spread over seven countries in Europe, Asia, and North America.

About Roquette Pharma

Backed by science and driven by innovation, Roquette Pharmaceutical Solutions mission is to support the development of pharmaceutical solutions that improve, sustain and save lives worldwide. Its diverse portfolio of reliable, sustainable excipients, nutraceutical active ingredients and APIs, combined with our unwavering commitment to regulatory compliance and quality, helps us redefine whats possible from product development and manufacturing, through to finished formulations. Working in collaboration with our customers and partners, Roquette Pharmaceutical Solutions is on a journey to solve the toughest challenges in drug development and delivery.

Roquette Pharma serves three major markets:

Pharmaceutical excipients supplies: we have been a pioneer of sustainably sourced pharmaceutical ingredients for over 40 years. Our portfolio unlocks the full spectrum of oral dosage forms, including prescription medicines. We offer our partners uncompromising quality, transparency and safety ensuring our ingredients produce consistently high results.

Nutraceutical active ingredients: Quality ingredients. Technical expertise. A vertically integrated supply chain. This is what underpins our leading range of solutions for nutraceutical and over-the-counter (OTC) products. Our plant-based excipients and APIs give formulators the flexibility to create custom dosage forms that put consumer needs first. Discover how we can help you achieve your supplement development goals.

Injectable and dialysis solutions: Rely on Roquette Pharma to deliver the highest purity raw materials for injectable dosage forms, dialysis solutions and specialty APIs. With decades of experience supporting parenteral preparation manufacturers, we offer a comprehensive range of pyrogen-free ingredients and osmotic agents, along with the knowledge you need to formulate lifesaving drugs.

The division sells over 50 different products, nearly all developed in-house and not available from other suppliers, to the worlds largest and most prominent pharmaceutical companies. It estimates that over 400 million consumers use a pharmaceutical product with ingredients from Roquette Pharma.

Roquette Pharmaceutical Solutions is active in 12 different countries through sales offices, production sites, or R&D activities. Its R&D laboratories are located in France, Singapore, and now also in the United States.

QUESTION 3

Through the interaction with customers, Roquette Pharmas R&D facility in Pennsylvania is inspired to develop new excipients. After a few attempts, a team of R&D scientists has success using an extract from leaves of the Green Ash, a typical North American tree, as a binding agent for a painkiller drug. The extract is a rather complex organic molecule.

In subsequent research, the team develops a several similar molecules through complete chemical synthesis in the laboratory. These molecules are not present in nature, as their structures are slightly different. When testing their properties, these similar molecules have the same beneficial properties and can be used as a binding agent for a painkiller drug.

In a final stage of the research process, a team of R&D engineers explores how to scale up the production process from laboratory to industry scale. They find out that it is possible to cost-efficiently extract the molecule from Green Ash leaves using a long process of standard and well-known techniques, yet all steps need to be performed in a very specific order and each step needs to be rightly timed. Any minor deviation from the process developed by the team will not result in the correct extraction of the molecule.

One customer developing a painkiller drug has reacted enthusiastically and wants to launch its new over-the-counter painkiller drug, including Roquette Pharmas binding agent, in America, Europe, Asia, and Australia. Yet, this customer insists on being Roquette Pharma's sole customer for the binding agent to disadvantage competitors that are working on similar painkiller drugs.

Before heading to a meeting with Roquette Pharma's legal team, the head of R&D wants to understand better what intellectual property has been developed and how it can be best protected from a business perspective. As you already feared, the head of R&D asks you to write a short analysis of this topic. Make sure that your analysis addresses these two questions:

What different types of intellectual property have been developed?

What is (are) the best method(s) to protect these elements of intellectual property? Why these method(s)

How should different types of intellectual property protection mechanisms be combined? Why in this way?