Press Room

Event

Webinar: Commercial Reality and Lifecycle Management of ASDs

Start
Thursday, April 20, 2023 - 16:00
Location: online

This is the third session of a three-part webinar series on Amorphous Solid Dispersions by Spray Drying: From Early Formulation to Commercial Lifecycle Management.

 

Thursday, April 20th

4:00pm GMT  |  11:00 am EDT  |  5:00 pm CEST

Registrations to the webinar are subject to approval.

 

Watch On-demand. 

Gated content. Registration is required.

 

Featured Hovione experts in this webinar
Webinar Series Spray Drying Speakers - Ines Salsinha | Hovione
Webinar Series Spray Drying Speakers - Tiago Profirio | Hovione
Inês Salsinha, M.Sc.

Quality Assurance Specialist

Site QA		 Tiago Porfirio, Ph.D.

R&D Manager, Particle Engineering

Corporate Technical Services 

 

After presenting Hovione’s formulation screening and scale-up methodologies for amorphous solid dispersions (ASDs) by spray drying, the webinar series will conclude by discussing the link between development, process validation and lifecycle management.

​​​​Inês Salsinha and Tiago Porfirio will explain how to perform a critical and extensive evaluation of potential failure modes, how to carry out risk assessment and how to define criticality to enable a successful Process Performance Qualification (PPQ).

Commercialization of ASDs requires statistical tools and methodologies to enable the continued process verification (CPV) application and ensure that the process remains under control. In this session, participants will gain insights into the importance of continuous improvement supported by continuous data analysis. The speakers will also outline the importance of commercial experience when using spray drying to produce ASDs. Case studies, namely regarding post approval changes, will be presented, and discussed.

 

Your Key Learning Objectives: 

  • Learn how to apply Quality Risk Management tools to get a successful Process Validation while ensuring a robust commercial stage.
  • Learn how statistical tools support the commercial lifecycle enhancing process control and product quality.
  • Discover how Continued Process Verification (CPV) and Product Quality Review (PQR) are key for a continuous improvement strategy.

 

Who Should Attend: 

This webinar is suitable for anyone working in formulation and process development of amorphous solid dispersions, procurement, and outsourcing teams or project managers, who are interested in understanding the end-to-end process for validation and commercialization of an ASD by Spray Drying.

 

Watch On-demand. 

Gated content. Registration is required.

 

 

Are you looking for a clear path from formulation screening to commercialization?

As an experienced manufacturer of ASDs by Spray Drying, Hovione will support your project by combining modeling capabilities, extensive process knowledge, and manufacturing capacity with an unmatched approval track record.

Get in touch today

 

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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 

Press Clipping
Pharma Manufacturing, 6 October 2026

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

Oct 06, 2026

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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Pharma Press Global, 6 October 2026

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

Oct 06, 2026

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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PharmTech, 5 October 2026

Can Continuous Tableting End Scale-Up for Complex Oral Drugs?

Oct 05, 2026

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