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Article / Sep 01, 2018

An Interview with Marco Gil, PhD

American Pharmaceutical Review, September 2018

In general, how has the efficiency and productivity of pharmaceuticals increased/evolved over the last 20 years and how much of this evolution is due the knowledge and experience contract development and manufacturing companies bring to the industry?

The technological evolution in manufacturing of pharmaceuticals has not evolved as rapidly as in other industries. Therefore, gains in efficiency and productivity have improved less than in those industries which needed to change. Contract and development and manufacturing companies have brought a higher productivity and more efficiency to the pharmaceutical industry through higher and better utilization of assets and leveraging the knowledge and experience gathered by working in many different products. These companies contributed significantly to the industry during the last 20 years as their business model focused intensely on increasing productivity and efficiency.

Over this same time period what has been Hovione’s mission? How has the company helped the pharmaceutical industry bring safe and effective treatments to market over the last 20 years?

Hovione’s mission was the contract development and manufacturing company that not only provides the benefits of an organization focused on development and manufacturing mentioned above but mostly an organization that brings innovation to the industry helping solve most complicated issues in development and manufacturing of medicines. For example, Hovione started many years ago devoting a significant effort in the understanding of particle engineering, how this could solve formulation challenges and what technologies could enable those engineered particles. Focusing on the inhalation and oral formulation of poorly soluble drugs through amorphous solid dispersions Hovione developed a wealth of knowledge and capabilities that have helped numerous companies developing new medicines that today help millions of patients worldwide that otherwise would not have been possible. Hovione today leads the development and manufacturing of amorphous solid dispersions by spray drying and has developed a wide range of new technologies like spray congealing and a combination of technologies that control particle size distribution, morphology, provide taste masking and controlled release properties that are of paramount importance for today’s pharmaceutical development and manufacturing.

Specifically, what services and expertise does Hovione currently offer to assist pharmaceutical clients to bring new drugs to market? Can you talk about your Integrated Science offering, capacity expansion, and your continuous manufacturing technologies?

Hovione constantly seeks new technologies, develops scientific knowledge and sees how we evolve our organization to solve issues for the pharmaceutical industry. Hovione today offers a comprehensive range of services from API to final drug product that include process development, clinical batch and commercial manufacturing involving experts in chemistry, process engineering, analytical sciences, particle engineering and formulation scientists. The development of a new medicine involves a wide range of expertise and technologies that Hovione has brought together ultimately (spray drying, microfluidization, spray congealing, co-precipitation) to provide better drugs and faster development so patients in need can have access to life changing medicines quicker.
Hovione offers an integrated approach from API to drug product as mentioned above. This integration not only speeds up product development but also allows our organization, scientists and engineers to share product/process knowledge. Our strategy has been also to develop this integrated approach at the same location to facilitate all the complex process associated with developing a drug and outsourcing. 
Therefore, Hovione started an investment program to add capacity at multiple locations (Europe and US) in API, spray drying and drug product formulation namely in tableting. Hovione believes that continuous manufacturing (in chemistry and drug product) brings a new way of developing and manufacturing medicines adding more quality and flexibility into the manufacture of medicines while allowing a faster development path by reducing the effort necessary in scaling up processes. Hovione has embraced these technologies and has invested in continuous tableting because we believe that this will be a transformational technology to the industry.

Looking ahead, are there any drug development and manufacturing technologies being developed now that will help pharma companies bring innovative products to the market? How will Hovione meet this challenge for its current and future clients?

Continuous processing is still a relatively new technology in the pharmaceutical industry. Its adoption will certainly help pharma companies to bring innovative products to the market faster. Hovione is very much interested in providing this option to pharma companies and having a contract manufacturing organization capable of providing this solution is of paramount importance for biotech companies and for the overall drug development industry.
There are other technologies being developed to address the challenge of poorly soluble drugs and other particle engineering manipulation solutions that Hovione is evaluating with the goal to bring these technologies to market to provide companies with options and better results. Being an innovative company with a strong pool of scientists Hovione is very well prepared to take some of these technologies into an industrial reality and providing a real solution to develop innovative products.

 

Read the article at APR's website.

 

 

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The investment includes both continuous and batch tableting capabilities, as well as connect spray drying with tablet production at its East Windsor campus. Hovione, a Portugal-based contract development and manufacturing organization (CDMO), plans to install a continuous tableting line at its East Windsor, New Jersey campus, adding drug product manufacturing capacity and an integrated pathway from amorphous solid dispersion production through commercial tablet manufacturing. The $35 million investment will bring the first ConsiGma CDC Flex system to Hovione’s recently opened 89 Twin Rivers facility. The line is expected to be commissioned in late 2027 and will support both continuous and batch operation at throughputs ranging from 1 to 200 kilograms per hour, according to the announcement. The system will allow customers to use the same equipment for development, clinical, and commercial production, with formulation development possible using as little as 1.5 kilograms of material. Hovione said the line will also be equipped for containment to 1 microgram per cubic meter to support the handling of highly potent compounds. The new capability will also connect Hovione’s spray-drying operations with tablet manufacturing at the East Windsor campus. The company recently opened a 31,000-square-foot facility at the campus with two commercial-scale spray dryers for manufacturing amorphous solid dispersions (ASDs), completing a $100 million investment in its New Jersey operations. Hovione said the integrated setup will allow customers to move from formulation and particle engineering through tablet production under one quality system, reducing technology transfer requirements and eliminating traditional scale-up between development and commercial production. The ConsiGma CDC Flex platform was jointly developed with GEA as part of a collaboration that began in 2022, the company said. The system incorporates automated process controls and process analytical technology for real-time monitoring during production. Hovione already operates continuous tableting technology at its Loures, Portugal site. In August, the company completed a more than €40 million expansion of its tablet development and manufacturing center there, adding a second commercial-scale tableting line and increasing the center's manufacturing area by 25%. The East Windsor installation will extend Hovione’s continuous tableting capabilities to the U.S. and expand its integrated drug development and manufacturing services for oral solid dosage products. Read the full article at Pharma Manufacturing 

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Hovione to add $35M continuous tableting line at New Jersey site

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Hovione, a globally integrated pharmaceutical contract development and manufacturing organisation (CDMO), will commission the world’s first ConsiGma CDC flex – a next generation continuous tableting line – at its East Windsor, New Jersey (USA) campus in late 2027. The line will be installed at 89 Twin Rivers, Hovione’s recently opened facility, expanding the company’s drug product capabilities and strengthening its integrated pharmaceutical development and manufacturing hub in the US. CDC ConsiGma flex system The project represents an investment of $35 million. Once installed it will create an integrated pathway from amorphous solid dispersion manufacturing via spray drying through commercial tablet production. The new flex will operate in continuous or batch modes across a very broad throughput range (from one to 200 kg/h). Customers will be able to develop a formulation using small quantities of material, down to 1.5 kg, and then run from very small clinical batches to large commercial batches using the same equipment. This is enabled by specialised design within the flex to effectively switch between continuous blenders of various sizes. Additionally, the line will be installed for containment to 1 µg/m³, supporting highly potent compounds. Continuous tableting is reshaping manufacturing of oral solid dosage medicines and is well suited to programmes in which speed, supply resilience and efficient use of high-value active pharmaceutical ingredients (APIs) are priorities. Inline process analytical technology (PAT) and automated controls also provide real-time quality monitoring. In parallel, the 2022 adoption of ICH Q13 regulatory framework, guidance specifically for continuous manufacturing of drug substances and drug products, provides harmonisation across the US, Europe and Japan. As of 2024, 17 products manufactured under the international guidance have been approved by the US Food and Drug Administration (FDA) alone.  Developed jointly with GEA, the ConsiGma CDC flex platform also incorporates SimpleCT, a suite of automation and control tools with smart interfaces that supports a single process from development to commercial supply. Designed for versatility and ease of use, these innovative developments simplify operation, improve efficiency and containment, and enhance operator safety. Read the full article at Pharma Press UK 

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Hovione to commission world’s first ConsiGma CDC flex, bringing next-generation continuous tableting to the US

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Key Takeaways Commissioning a US-based ConsiGma CDC Flex line enables end-to-end spray drying-to-tablet manufacture within a single site and quality system, reducing comparability and technology-transfer burdens. Elimination of conventional scale-up is enabled by using the same equipment from early development through commercial supply, minimizing engineering runs and conserving scarce API. Operational flexibility spans batch or continuous modes and 1–200 kg/h throughput, with scale adjustment achieved by switching continuous blenders rather than replatforming processes. High-containment design to 1 µg/m³ expands suitability for highly potent oral solid-dose programs while maintaining integrated development-to-commercial workflows. Regulatory momentum for continuous manufacturing is supported by ICH Q13 harmonization, increasing FDA approvals, and platforms leveraging inline PAT and automated control suites for real-time quality assurance. Hovione announced on Oct. 5, 2026, that it will commission the ConsiGma CDC Flex, a next-generation continuous direct compression tableting platform jointly developed with GEA. The investment is designed to link amorphous solid dispersion manufacturing via spray drying with commercial tablet production at a single US site operating under one quality system. The line will run in either continuous or batch mode at throughputs from 1 to 200 kg/h. Formulation development can begin with as little as 1.5 kg of material, and the same equipment can then support everything from very small clinical batches to large commercial runs, enabled by a design that allows the system to switch between continuous blenders of different sizes. The installation will also be contained to 1 µg/m³ to accommodate highly potent compounds. "Hovione will be the first company in the world to offer the ConsiGma® CDC Flex, bringing this next-generation technology with unprecedented flexibility, simplicity and cost-efficiency in continuous tableting," said Marco Gil and António Almeida, co-CEOs, Hovione, said in a press release. "This investment also advances our strategy of building integrated capabilities close to customers in key markets. By adding this new line at East Windsor, we are broadening access to this technology in the U.S. and giving customers a more direct and accelerated path for developing and commercializing complex oral medicines." What Does a Single Development-To-Commercial Line Change? For formulators and process engineers, the most consequential claim is the removal of traditional scale-up. Moving a process from development equipment to commercial equipment typically requires engineering runs, bridging work, and consumption of scarce API, all of which weigh heavily on early programs with limited material. "Installing the CDC Flex at 89 Twin Rivers makes continuous tableting part of an integrated US development and manufacturing workflow," said David Basile, Vice President of Technical Operations, Hovione, in the press release. "Customers can move from formulation and particle engineering to commercial tablets with one Hovione team and one quality system, eliminating traditional scale-up while gaining greater production flexibility, process control and supply continuity." Co-locating spray drying and tableting is also significant because amorphous solid dispersions remain a primary solubility-enhancement route for poorly soluble molecules, and transferring intermediates between sites or vendors adds technology transfer and comparability burdens. The new line builds on the company's earlier US expansion; Hovione recently completed a $100 million investment to bolster US capacity in particle design, amorphous solid dispersions via spray drying, and batch and continuous tableting. How Is the Regulatory Environment Shaping Continuous Tableting Adoption? The company points to the 2022 adoption of ICH Q13, which provides harmonized guidance for continuous manufacturing of drug substances and drug products across the US, Europe, and Japan. Hovione reports that, as of 2024, FDA alone had approved 17 products manufactured under the guidance. Speaking on ICH Q13, FDA's Kelley Burridge, PhD, "Perceived barriers to continuous manufacturing have been falling one by one," and noted an FDA publication showing faster approval times for products with continuous manufacturing elements than for comparable batch products. The platform incorporates inline process analytical technology and automated controls for real-time quality monitoring, along with SimpleCT, an automation and control suite intended to support a single process from development through commercial supply. For sponsors weighing supply resilience and regional sourcing, the East Windsor installation extends a capability that Hovione says only it currently offers as a contract development and manufacturing organization.   Read the full article at PharmTech.com  

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