Press Room

Press Release / Jun 16, 2005

Allos Therapeutics and Hovione Enter Into Manufacturing Agreement for EFAPROXYN(TM) Bulk Drug Substance

Allos Therapeutics, Inc. and Hovione announced today that they have entered into a long-term manufacturing agreement for the supply of EFAPROXYN bulk drug substance, efaproxiral sodium.

Allos Therapeutics, Inc. (Nasdaq: ALTH) and Hovione announced today that they have entered into a long-term manufacturing agreement for the supply of EFAPROXYN bulk drug substance, efaproxiral sodium. Under the agreement, Hovione is committed to manufacture and supply Allos with sufficient quantities of efaproxiral sodium to support Allos' anticipated requirements for both the pre-and post-commercialization phases of production.

EFAPROXYN is currently the subject of a confirmatory Phase 3 trial, called ENRICH, designed to compare the effect of whole brain radiation therapy with supplemental oxygen with or without EFAPROXYN in women with brain metastases originating from breast cancer. This randomized, open-label study will seek to enroll 360 patients at up to 125 leading cancer centers across North America, Europe and South America. The trial began in February 2004 and is expected to complete enrollment during the second half of 2006.

The manufacturing agreement is the most recent step in a relationship between the two companies that began in 1997. Under a prior agreement between the parties, Hovione manufactured a majority of the bulk drug substance used by Allos in its clinical trials of EFAPROXYN. Hovione has already manufactured four batches of efaproxiral sodium at commercial scale using a process that they successfully validated in 2001. Hovione is in good standing with the FDA, having passed recent inspections.

"This manufacturing agreement is an important step in our preparation for the potential commercialization of EFAPROXYN," said Michael E. Hart, President and Chief Executive Officer of Allos. "We have benefited from Hovione's commitment to working with companies like Allos and feel that Hovione's expertise in production of APIs for injectable products makes them an ideal partner for us."

About EFAPROXYN

EFAPROXYN is the first synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, areas of tumors during radiation therapy by facilitating the release of oxygen from hemoglobin, the oxygen-carrying protein contained within red blood cells, and increasing the level of oxygen in tumors. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy. By increasing tumor oxygenation, Allos believes that EFAPROXYN has the potential to enhance the efficacy of standard radiation therapy.

About Allos Therapeutics, Inc.

Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos' lead product candidate, EFAPROXYN, is a synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, tumor tissue during radiation therapy. EFAPROXYN is currently being evaluated as an adjunct to whole brain radiation therapy in a pivotal Phase 3 trial in women with brain metastases originating from breast cancer. Allos' other product candidates are: PDX (pralatrexate), a small molecule chemotherapeutic agent (DHFR inhibitor) currently under investigation as both a single agent and in combination therapy regimens in patients with non-small cell lung cancer and Non-Hodgkin's lymphoma; and RH1, a small molecule chemotherapeutic agent bioactivated by the enzyme DT-diaphorase currently under evaluation in patients with advanced solid tumors. For more information, visit the company's website at www.allos.com

About Hovione

Hovione, based in Portugal, is an international group dedicated to the process development and synthesis of active pharmaceutical ingredients serving exclusively the pharmaceutical industry. With FDA inspected plants in Europe and the Far East and a Technology Transfer Centre in New Jersey, USA, Hovione is committed to the highest levels of service, technical expertise and cGMP quality standards. Hovione focuses on finding scientific and industrial solutions for APIs of increased complexity and for Enhanced APIs(TM) having developed, among other, special process capabilities in the areas of injectable grade APIs, particle design and inhalation drug delivery. For more information, visit the company's website at www.hovione.com

Safe Harbor Statement

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements concerning Allos' projected timelines for completing enrollment in the ENRICH study, the potential safety and efficacy of EFAPROXYN, and other statements which are other than statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others: that Allos may experience difficulties or delays in its clinical trials, whether caused by adverse events, investigative site initiation rates, patient enrollment rates, regulatory issues or other factors; and that clinical trials may not demonstrate the safety and efficacy of Allos' product candidates in their target indications. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of Allos' Annual Report on Form 10-K for the year ended December 31, 2004 and in Allos' other periodic reports and filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2005. Allos cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Allos on the date hereof, and Allos undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this presentation, except as required by law.

Note: EFAPROXYNTM and the Allos logo are trademarks of Allos Therapeutics, Inc.

SOURCE: Allos Therapeutics, Inc.; Hovione

Jennifer Neiman, Manager, Corporate Communications of Allos Therapeutics, +1-720-540-5227; or Isabel Pina, Corporate Communication Manager of Hovione, +351-21-982-9362

 

Allos Therapeutics and Hovione Enter Into Manufacturing Agreement for EFAPROXYN(TM) Bulk Drug Substance

16/06/2005

Allos Therapeutics, Inc. (Nasdaq: ALTH) and Hovione announced today that they have entered into a long-term manufacturing agreement for the supply of EFAPROXYN bulk drug substance, efaproxiral sodium. Under the agreement, Hovione is committed to manufacture and supply Allos with sufficient quantities of efaproxiral sodium to support Allos' anticipated requirements for both the pre-and post-commercialization phases of production.

EFAPROXYN is currently the subject of a confirmatory Phase 3 trial, called ENRICH, designed to compare the effect of whole brain radiation therapy with supplemental oxygen with or without EFAPROXYN in women with brain metastases originating from breast cancer. This randomized, open-label study will seek to enroll 360 patients at up to 125 leading cancer centers across North America, Europe and South America. The trial began in February 2004 and is expected to complete enrollment during the second half of 2006.

The manufacturing agreement is the most recent step in a relationship between the two companies that began in 1997. Under a prior agreement between the parties, Hovione manufactured a majority of the bulk drug substance used by Allos in its clinical trials of EFAPROXYN. Hovione has already manufactured four batches of efaproxiral sodium at commercial scale using a process that they successfully validated in 2001. Hovione is in good standing with the FDA, having passed recent inspections.

"This manufacturing agreement is an important step in our preparation for the potential commercialization of EFAPROXYN," said Michael E. Hart, President and Chief Executive Officer of Allos. "We have benefited from Hovione's commitment to working with companies like Allos and feel that Hovione's expertise in production of APIs for injectable products makes them an ideal partner for us."

 

About EFAPROXYN
EFAPROXYN is the first synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, areas of tumors during radiation therapy by facilitating the release of oxygen from hemoglobin, the oxygen-carrying protein contained within red blood cells, and increasing the level of oxygen in tumors. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy. By increasing tumor oxygenation, Allos believes that EFAPROXYN has the potential to enhance the efficacy of standard radiation therapy.

About Allos Therapeutics, Inc.

Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos' lead product candidate, EFAPROXYN, is a synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, tumor tissue during radiation therapy. EFAPROXYN is currently being evaluated as an adjunct to whole brain radiation therapy in a pivotal Phase 3 trial in women with brain metastases originating from breast cancer. Allos' other product candidates are: PDX (pralatrexate), a small molecule chemotherapeutic agent (DHFR inhibitor) currently under investigation as both a single agent and in combination therapy regimens in patients with non-small cell lung cancer and Non-Hodgkin's lymphoma; and RH1, a small molecule chemotherapeutic agent bioactivated by the enzyme DT-diaphorase currently under evaluation in patients with advanced solid tumors. For more information, visit the company's web site at www.allos.com.

About Hovione
Hovione, based in Portugal, is an international group dedicated to the process development and synthesis of active pharmaceutical ingredients serving exclusively the pharmaceutical industry. With FDA inspected plants in Europe and the Far East and a Technology Transfer Centre in New Jersey, USA, Hovione is committed to the highest levels of service, technical expertise and cGMP quality standards. Hovione focuses on finding scientific and industrial solutions for APIs of increased complexity and for Enhanced APIs(TM) having developed, among other, special process capabilities in the areas of injectable grade APIs, particle design and inhalation drug delivery. For more information, visit the company's web site at www.hovione.com.

 

Safe Harbor Statement
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements concerning Allos' projected timelines for completing enrollment in the ENRICH study, the potential safety and efficacy of EFAPROXYN, and other statements which are other than statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others: that Allos may experience difficulties or delays in its clinical trials, whether caused by adverse events, investigative site initiation rates, patient enrollment rates, regulatory issues or other factors; and that clinical trials may not demonstrate the safety and efficacy of Allos' product candidates in their target indications. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of Allos' Annual Report on Form 10-K for the year ended December 31, 2004 and in Allos' other periodic reports and filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2005. Allos cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Allos on the date hereof, and Allos undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this presentation, except as required by law.

Note: EFAPROXYNTM and the Allos logo are trademarks of Allos Therapeutics, Inc.

SOURCE: Allos Therapeutics, Inc.; Hovione

Jennifer Neiman, Manager, Corporate Communications of Allos Therapeutics, +1-720-540-5227, jneiman@allos.com ; or Isabel Pina, Corporate Communication Manager of Hovione, +351-21-982-9362, e-mail: )

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The CDMO is preparing for its New Jersey facility to become fully operational this year. Hovione’s multimillion-dollar investment in expanding its East Windsor, NJ manufacturing site is quickly coming to fruition. Contract Pharma will be visiting the site later in April 2026 to provide a unique overview of what’s new. As a preview, the Contract Pharma team met with Hovione at the Drug, Chemical & Associated Technologies Association (DCAT) Week. David Basile, Vice President of Technical Operations—Americas, spoke at the opening Member Company Announcement Forum on March 23, 2026. In this interview, Basile expands on his remarks at the Announcement Forum. As he explains, Hovione is concentrating not only on New Jersey, but also on facilities in Ireland and Portugal. Contract Pharma: Good manufacturing practice (GMP) operations will soon be fully operational at the New Jersey facility. How has Hovione progressed through this process since the initial investment cycle was announced last fall—or even prior? David Basile: It’s been a really great journey and evolution over the last two to three years, conceiving the plan to grow our U.S. footprint. It was one of the reasons I came aboard with Hovione, to grow that footprint and build our commercial manufacturing prowess in the States. In New Jersey, we had originated [the site] as a tech transfer center. [But] we wanted to grow the organization to be more equivalent with our Portugal and Ireland sites, to do more large-scale manufacturing. So, this is part of that journey. And that’s not just bricks-and-mortar and machinery. It’s been people, talent, partnerships with clients, supporting functions such as QC [quality control] and analytical development. We’re growing our R&D teams as well. It’s a comprehensive approach to systems, people, and processes. CP: At the Member Company Announcement Forum, you ran through some of the major technical specifications of the NJ expansion. Can you talk about a few of the highlights and their capabilities? Basile: This year we’ll be starting up two PSD-3 scale spray dryers. This is a useful scale of machinery for our clients. It plays nicely between the PSD-2 and PSD-4 scales that we have elsewhere in the network. I’d say it’s medium-to-large scale capacity; we could do 30 metric tons annually out of this type of a unit. Product to product, that differs, but we do have products that put that kind of volume out in a PSD-3, so it’s not small-scale. Customers want to hear this because [they want to gain] efficiency with their batch size, and turnaround time. And when we campaign, we can really see significant throughput with this line up of new machinery and assets. The first machine that we will start up is a Hastelloy unit, which is unique. We took a pause [in the construction timeline] to make that upgrade, as we had a client that needed this configuration. There are additional clients that are interested in it too, because you can do acidic solutions and more aggressive kinds of formulations as well as solvent-based formulations. So that’s a unique element of that first machine. The second machine is being qualified later this year. Kind of a twin, but this one is standard 316 stainless steel.  CP: When a company brings a new or expanded facility online, new personnel often accompanies the new tech. What is the workforce addition that you expect, and what are the challenges of retaining top talent? Basile: In preparation for commissioning and startup of this new equipment, we’ve already ramped our headcount up, to be ready for GMP launch. We’ve added roughly 20 employees in preparation for this first machine to go [live]. Over the next 18-plus months, we could see something on a similar scale, getting us up to that 40–50 headcount range for that facility once it’s fully operational—and more later on in 2028, when we bring in the CDC [continuous direct compression] Flex unit. That’s what’s really going to be transformative about this new facility: that integrated offering coming to life. CP: Even if the NJ facility is top of mind right now, let’s also touch on some of your plans in Europe. What is your vision for expanding in Europe in the next two to three years? Basile: Ideally, Hovione’s aim is to build an equivalent manufacturing network, where clients can go to any site across the globe and get a similar breadth and scale of offering. We’re doing that now in Ireland, expanding our PSD-4 scale spray drying. One unit was recently installed. Late last year, it went live. Then there’s at least one other new PSD-4 in motion, which is really exciting, because [spray dryers] at this site were historically [exclusive to] larger chemistry manufacturing for API [active pharmaceutical ingredient] synthesis. So now, they’re further building their muscle with additional large scale spray drying capacity. On the Portugal side, there’s a lot of great things going on. Our Tejo campus, in Seixal, Portugal, is a massive, 4.5-million-square-foot plot of land, and there’s a new, modular facility going up there. It’s incredibly exciting. The design of the facility has been well-thought through with material flows [and] gravity-fed processes. Here, we minimize handling and [maximize] speed of processing. It’s scalable. We call each one of these building segments a finger. You can copy and paste these fingers, and they are built to house both spray drying and drug product assets within each unit. So, why is that relevant? Because we can easily scale the number of fingers. When customers say, “we need more capacity,” we have the design on the table ready to go. We know how to execute, we know how to build and implement our technology platforms in a short timeframe. Deployment timeframes are truly becoming more and more relevant to our clients. CP: From last year’s DCAT Week to this year’s, what conversations are you having with industry colleagues about ever-changing geopolitics? Basile: We’re seeing that local, regional manufacturing capacity is vital. The concept of U.S. for U.S. and China for China seems to be a common theme that our clients are talking about. We happen to have an edge, as we [have already] started our journey of expanding our domestic U.S. capacity. So I think that’s a crucial piece to the puzzle, having dual-sided Atlantic manufacturing operations. The traditional global supply chain model is being challenged. Having soup-to-nuts sites that are fully autonomous in development, scale-up, tech transfer, all the way to commercial scale operation, is vital to Hovione, and how we’re protecting our supply chain. [Concerning] starting raw materials and Tier 2 suppliers, our procurement teams are out in the market making sure that there’s no single point of failure for critical materials [like] polymers and solvents that we utilize. We’re managing and mitigating risk by looking at those secondary suppliers across different geographies. CP: Encapsulating your planned expansions on both sides of the Atlantic, how would you sum up the value to the customer? Basile: It’s about speed-to-market. It’s one partner from early-phase development, clinical scale, all the way through commercial. They gain comfort, trust, and not just capacity and equipment time; it’s also about competency and depth of scientific expertise. We’re not just a traditional CDMO. There’s unique expertise in particle science and spray dried dispersions that we offer our clients that they don’t have. [With] traditional CDMOs, customers typically pay for time in [a particular] unit, for example, they’d say: “I need a machine, and I need [it for] three weeks.” Hovione is truly a partner to our clients. They’re leveraging our platforms, our know-how in spray drying, and our know-how in equipment design. Read the article at ContractPharma.com  

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Contract Pharma, 6 April 2026

Hovione Eyeing Manufacturing Expansion on Both Sides of Atlantic

Apr 06, 2026

Continuous manufacturing has long promised faster development, improved process understanding and, in the absence of scale-up, smoother commercialization. For many pharmaceutical R&D teams, those benefits are well understood. What still holds them back, however, is not scepticism about the concept; it’s the perceived effort required to implement it To increase the adoption of continuous manufacturing, particularly for tablet compression applications, GEA and Hovione have been working together to overcome these hurdles and demonstrate how solutions such as SimpleCT can accelerate development, provide greater flexibility and simplify production. Manufacturing Chemist spoke to Anthony Tantuccio (pictured), Fellow Scientist, Continuous Tableting/Technology Intensification at Hovione, to find out more.  Simplifying continuous operations: lowering the barrier to faster development Continuous manufacturing (CM) solutions can accelerate product development, reduce costs, improve operational economics and make production more agile with less downtime. With advanced controls and tightly linked process data to product output, it enables more consistent tablet quality. “It’s a more efficient and flexible mode of manufacturing,” notes Tantuccio, “offering consistent and reliable tablet production with fewer operators and less waste of precious active pharmaceutical ingredients (APIs) and raw materials.” “Yet,” he adds, “running a continuous direct compression (CDC) line during development can often be a daunting task.” Any inherent complexity stems from managing parallel, integrated operations that all occur at the same time (as opposed to a single unit operation). “Even relatively straightforward duties — such as collecting samples, changing process conditions or running Residence Time Distribution (RTD) tests — can become multi-person activities with a high potential for error.” SimpleCT focuses on simplifying these development-critical tasks, not by removing flexibility but by embedding automation, structure and guidance directly into the equipment and control systems. The result is a toolset designed for how R&D teams develop continuous tableting — mapping a design space and generating calibration samples within a single run — while reducing manual co-ordination and increasing confidence in the data generated. “Rather than treating continuous development as a scaled-down version of commercial manufacturing,” explains Tantuccio, “SimpleCT recognises that development has different priorities: rapid learning, efficient experimentation and robust process insight.” Accelerating development cycles and time to market One of the most immediate benefits of SimpleCT for R&D teams is speed. Development programmes on continuous lines can be significantly shortened when routine yet complex tasks are automated and synchronised across the system. “During many development scenarios,” says Tantuccio, “Design of Experiments (DoE) execution remains largely manual and labour-intensive — introducing inefficiencies, safety risks and data variability at a time when consistency and speed are paramount.” Tools such as assisted DoE (ADoE) allow development steps to be predefined and executed automatically. Instead of manually adjusting dozens of parameters under time pressure, operators can progress through experimental conditions in a controlled and repeatable way. This reduces the setup time between experiments and minimises the risk of incorrect parameter entries or missed steps. “Shorter development cycles translate directly into faster decision-making and earlier progression to clinical or commercial stages,” adds Tantuccio: “Even a modest reduction in development time — measured in weeks or months — can have a meaningful impact on time-to-market and overall project value. Furthermore, unrealised capacity can become available.” Speed alone is not enough, though; R&D teams also need confidence in their understanding of the process. SimpleCT enhances operational insight by improving how information is presented and captured during development. More detailed screens, clearer alarm messages and time-aligned datasets help operators to understand not just that something has happened … but why it happened. At the core of SimpleCT is the ability to define and execute multivariate experiments within clearly defined operating ranges by a single person. Reducing reliance on specialised personnel Traditional continuous development often assumes the availability of highly experienced operators or process engineers who can manage simultaneous set-point changes, sampling schedules, data alignment and troubleshooting in real-time. In practice, this creates a bottleneck: development becomes dependent on a small number of experts. “SimpleCT is designed to lower that dependency,” suggests Tantuccio. “Automated sampling systems, guided workflows and more informative operator interfaces allow development activities to be done by fewer people with less reliance on niche expertise. For example, automated tablet sampling systems can collect, bag, label and link samples to their respective process conditions at high frequency without manual coordination and management.” Similarly, automated residence mass collection enables system measurement of how much material is present in the blender during steady operation — a standard requirement for understanding mixing behaviour — and time-aligned data capture at the touch of a button. Tasks that previously required multiple operators working closely together can now be performed safely and consistently by a single trained user. “This reduction in headcount pressure is particularly valuable in R&D environments when resources are limited and teams are balancing multiple programmes simultaneously,” Tantuccio adds. Improving process insight during development Manual “spiking” operations have historically posed safety and operational concerns. Spiking involves adding a tracer powder to the process and monitoring its passage through the system, enabling mapping of residence time and identification of key process dynamic behaviour. These activities frequently require operators to work in proximity to moving equipment and APIs, sometimes under time pressure. Clear communication between the operators responsible for spiking, sample collection and human–machine interface (HMI) adjustments is essential, yet even minor misalignments can compromise data integrity or create safety risks. “As the number of experimental runs increases, so too does the likelihood of human error, mislabelling or incomplete data capture,” comments Tantuccio. Automated RTD tools, such as contained automatic spiking (CAS) systems, ensure accurate timing, consistent spike introduction and full time-alignment between process data and experimental events. This removes a common source of uncertainty in RTD studies and allows teams to focus on interpreting results rather than questioning data quality. “By reducing manual steps and human error, SimpleCT supports smoother experimentation and faster learning — enabling teams to identify operating windows, sensitivities and transfer risks earlier in development.” A pragmatic path to continuous adoption “Importantly,” enthuses Tantuccio, “SimpleCT is not positioned as a radical departure from existing development practices. It is a pragmatic, application-based enabler for teams that already see the value of CM but have hesitated because of its perceived operational complexity.” The SimpleCT toolset integrates across GEA’s continuous ecosystem — including CDC and related technologies. This lowers the psychological and operational barrier to entry, making continuous development feel manageable rather than overwhelming. “For many pharmaceutical organisations, this derisking effect is just as important as speed or efficiency. By simplifying day-to-day development activities, SimpleCT allows teams to build confidence in continuous tableting early, thereby creating a stronger foundation for later development stages and commercialisation,” Tantuccio adds. From complexity to confidence The take-home message from Tantuccio is that continuous manufacturing doesn’t need to be complicated to be powerful. “For R&D teams, the real challenge has never been understanding the theory; it’s been managing the practical realities of development on integrated, all-at-once and always-on systems.” By removing manual handling and co-ordination from critical development steps, SimpleCT from GEA and Hovione delivers tangible benefits in three key areas: reliability, ease of operation and data assurance. Automation minimises the risk of human error for standardised workflows, whereas push-button execution allows complex multivariate experiments to be done efficiently and safely. The quality and consistency of the data generated provide a strong foundation for process understanding, supporting faster decision-making and more robust commercialization activities. By automating complex tasks, reducing headcount requirements and improving process insights, SimpleCT enables faster, more confident development on continuous lines. “For teams ready to move beyond batch — but looking for a simpler way forward — continuous has just become easier,” concludes Tantuccio. “With SimpleCT, you can take the complexity out of continuous development and get to market even faster.”  SimpleCT: accelerating time-to-market In an increasingly competitive landscape, the ability to develop and optimise tablet formulations quickly can provide a decisive advantage. Part of GEA’s ConsiGma® portfolio, SimpleCT supports the faster development of direct compression products, reduces material consumption during experimentation and shortens overall time-to-market. At the same time, improved operator safety and reduced exposure to APIs align with the industry’s ongoing focus on sustainable and responsible manufacturing practices. Read the full article at ManufacturingChemist.com  

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With key expansions coming to fruition on either side of the pond, specialist CDMO Hovione is making sure that drugmakers can access its particle engineering expertise across multiple geographies.  That flexibility will be key for the Portugal-based company in the coming years as the pharmaceutical industry continues to embrace more regional supply chains. In a recent interview, Hovione's David Basile, VP of technical operations for the Americas, discussed this trend and the manufacturer's expansion project, which is set to come online in New Jersey next month.  In the coming weeks, Hovione plans to debut a new spray drying expansion at its campus in East Windsor, New Jersey. The company has invested $100 million to expand its campus, including new construction and the acquisition of an additional facility and greenfield land.  Specifically, one of two pharmaceutical spray drying-3 units, or PSD-3 units, will come online in the coming weeks to tackle amorphous active pharmaceutical ingredients (APIs) and amorphous solid dispersions, according to the company. With some 80% of new small molecules in development insoluble in water, Hovione’s particle engineering and amorphous solid dispersion platform helps medicine developers improve the solubility, bioavailability, and, in some cases, the stability of their drug candidates, Basile said.  The company boasts spray dryers from the lab scale to PSD3 at its original facility in East Windsor, in addition to the pair of large-scale machines about to be activated at the campus' new facility.  “We’re going for a single, unified site with capabilities across the campus to do drug substance through finished drug product under one governance and quality system,” - Basile told Fierce.   Read the full article at FiercePharma.com

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