Press Room

Event

ConsiGma® Connect

Start

Tuesday, October 22, 2024 - 08:00

End

Thursday, October 24, 2024 - 18:00

Location: Mumbai and Hyderabad, India

ConsiGma® Connect India is a premier event that brings together experts, innovators, and decision-makers from the pharmaceutical industry to explore the latest advancements in continuous manufacturing technology. Organized by our long-term partner GEA, this event is dedicated to showcasing cutting-edge solutions that aim to revolutionize pharmaceutical manufacturing by improving efficiency, reducing costs, and accelerating the time to market for critical therapies.

The focus of the event is to highlight the growing role of continuous manufacturing, which represents a significant paradigm shift in drug production. Attendees will gain valuable insights into the latest technological developments, operational benefits, and real-world case studies from industry leaders who have successfully implemented continuous manufacturing processes.

As a leading CDMO company in continuous tableting, Hovione is proud to contribute to this transformative event. Our expert, Dr. Sarang Oka, will be presenting on the real-world applications and challenges of implementing continuous tableting technology at a commercial scale.

On October 22 and 24, don't miss the session "Challenges and Opportunities in Implementing Continuous Tableting: A CDMO Perspective"

Abstract: Continuous manufacturing of tableted drug products or continuous tableting (CT) represents a paradigm shift in pharmaceutical manufacturing, promising increased efficiency, reduced costs, and accelerated pathways for drug approval. These opportunities represent an increasing incentive for technological adoption in light of an ever evolving, competitive industry environment. However, on the road to fully realizing these opportunities are also challenges, both tangible and perceived, that must be addressed in order to facilitate widespread adoption. Some well documented challenges, from an end user perspective include, higher degree of complexity in the operation, non-harmonious regulatory expectations, a more intensive cleaning operation compared to batch processing and challenges with implementation of online and real time process monitoring (PAT) technology.

The objective of this talk is to present a CDMO perspective on the aforementioned challenges and subsequent mechanisms to tackle them. This is done with the help of case studies including an example of commercial implementation of CT at Hovione. Hovione’s collaborative work with GEA on creation of tools that simplify manufacturing operations and increase equipment flexibility will also be shared. Concluding comments will constitute key learnings from the implementation of the technology at Hovione.

Key Learnings:

Learn about important considerations in commercial implementation of continuous tableting. This includes lessons learnt over the course of the lifecycle of implementation starting from installation of the equipment, through qualification, tech transfer and finally during commercial manufacturing.
Learn about the latest development from the Hovione-GEA partnership on continuous tableting, specifically, on a flexible approach to direct compression along with the latest advances in technology simplification.

Who Should Attend:

Individuals and organizations who wish to hear peer experience about the implementation of continuous tableting technology.
Current and aspiring practitioners of technology who are curious about operational challenges, and opportunities to tackle them.

Featured Hovione experts in this session
	Sarang Oka Production Senior Manager Drug Product Continuous Manufacturing Speaker Bio: Dr. Sarang Oka is a Scientific Fellow at Hovione where he is tasked with intensifying the implementation of continuous tableting within the organization. In his prior roles at Hovione, Dr. Oka was responsible was various functions at Hovione’s continuous drug product manufacturing installation (CT501) in East Windsor, New Jersey, including PAT, technical services and manufacturing operations where he successfully led the validation and tech transfer of a commercial program from one of Hovione’s partners to CT501. Dr. Oka received his PhD in Chemical Engineering from Rutgers University. Dr. Oka holds a BS in chemical engineering from Mumbai University

Featured Hovione experts in this session

Sarang Oka

Production Senior Manager

Drug Product Continuous Manufacturing

Speaker Bio:

Dr. Sarang Oka is a Scientific Fellow at Hovione where he is tasked with intensifying the implementation of continuous tableting within the organization. In his prior roles at Hovione, Dr. Oka was responsible was various functions at Hovione’s continuous drug product manufacturing installation (CT501) in East Windsor, New Jersey, including PAT, technical services and manufacturing operations where he successfully led the validation and tech transfer of a commercial program from one of Hovione’s partners to CT501. Dr. Oka received his PhD in Chemical Engineering from Rutgers University. Dr. Oka holds a BS in chemical engineering from Mumbai University

Learn more about the ConsiGma® Connect in India.

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The Future is Continuous

Meet our experts and find out if Continuous Tableting is right for your product.

Webinar - Register today for the most comprehensive three-part webinar series about Continuous Tableting (CT) for drug product. Hovione will be joining experts from Merck, Vertex Pharmaceuticals and GEA Group to present the "Opportunities, Challenges and Success in Implementing Continuous Tableting – From R&D to Commercial Manufacturing".
Scientific Article - Read our latest scientific article about Continuous Tableting - “Continuous Tableting and the Road to Global Adoption

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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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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