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Article / Mar 01, 2025

SPECIAL FEATURE - Bioavailability & Solubility: The Promise of Novel Ingredients

Drug Development & Delivery, 01 March 2025

There is somewhat of a consensus in life sciences that there have been significant advancements in improving bioavailability. Solubility, however, continues to elude formulators. Excipients are often lauded as a solution to tackling these challenges, but still do fall short. In a 2020 US Pharmacopeia (USP) survey of drug formulators, 84% said that the current roster of excipients present in approved drug products has imposed limitations on drug development, and as many as 28% experienced a discontinuation of drug development as a result of excipient limitations.

Novel excipients may be the answer. In September 2023, the Office of New Drugs and the Center for Drug Evaluation and Research (CDER) launched a voluntary Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME). This program is intended to allow biopharmaceutical manufacturers to obtain FDA review of novel excipients. The development of novel excipients is gaining momentum as pharmaceutical companies seek improved performance and versatility in drug formulations. Novel substances support nanoparticle drug delivery for oncological medications to provide better stability and adoption of medicines.

“The invention of novel excipients bearing the amphiphilic and solubilization characteristics in the recent past has helped excipient and drug manufacturers alike to overcome the regulatory barriers for expediting the new drug candidates to market,” says Shaukat Ali, PhD, Senior Director of Scientific Affairs and Technical Marketing at Ascendia Pharmaceutical Solutions.

According to a May 2024 USP white paper: “While the FDA PRIME program represents a step in a new regulatory direction for excipients, drug developers are currently reluctant to use novel excipients as there is no independent FDA regulatory pathway outside of its drug application and approval process to review and evaluate the safety and toxicity of an excipient for introduction into a new drug, abbreviated new drug, or non-prescription drug. FDA may determine that novel excipients are not fully supported by the submitted safety data such as for the proposed level of exposure, route of administration, duration of exposure, and patient population. An entire drug application using a novel excipient could be rejected due to uncertainty surrounding acceptance of the excipient by FDA. Considering the barriers to using novel excipients that exist in the normal application process for drug products, USP supports the development of a transparent, independent approval pathway for novel excipients.”

This exclusive Drug Development & Delivery annual report explores the use of novel excipients as well as other methods and technologies for tackling bioavailability and solubility once and for all.

[...]

Hovione: Early-Stage ASDs by Spray Drying Result in Viable Oral Dosage Form

Amorphous solids dispersions (ASDs) remain the most used enabling platform for solubility enhancement. There are a variety of molecule structures in the pipeline that require tailored bioenhance­ment, including the common greaseballs as well as chameleonic and brick-dust APIs. “ASDs by spray drying are a versatile platform to formulate across the board,” says Inês Ramos, R&D Manager (Formula­tion Development, Oral Drug Product) at Hovione.

For BCS II and IV compounds, bioavailability enhancement is driven by absorption enhancement needs, target product profile, and drug molecular fea­tures. “To maintain a strong focus on man­ufacturability since early-stage, the delivery of a viable ASD oral dosage form follows an integrated approach involving ASD for­mulation screening, particle engineering, drug product formulation and process de­velopment using data-driven tools to ex­pedite development,” says Dr. Ramos.

Hovione’s approach relies on a streamlined workflow supported by com­putational tools that starts with a “technol­ogy fitting” to assess the suitability of using ASDs by spray drying. ASD development includes a comprehensive high-through­put formulation screening (ASD-HIPROS™ proprietary platform that includes com­mon polymers and alternative excipients such as the Dispersome® technology), de­signed to fast-track first-in-human (FiH) formulations that are scalable and provide adequate performance. The ASD-HIPROS platform requires a few grams of API and less than eight weeks to narrow down thousands of possible formulations to the most viable candidates. The drug product intermediate is then formulated into a tablet, capsule, or pellets/granules for oral delivery. “This methodology was designed to expedite the delivery of an enabling for­mulation and an industrially viable manu­facturing process,” says Dr. Ramos. “The goal is to maintain performance and en­sure patience compliance.”

 

Read the full article on Drug-Dev.com

 

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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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