Hovione

Do you have problems with insoluble drugs or nutraceutical candidates? This new webinar highlights the use of beta-lactoglobulin as a novel excipient in Dispersome® formulations, a new solubility-enhancing technology that can improve performance and increase bioavailability.

https://www.pharmtech.com/pt_w/solving-the-insoluble

Poor drug solubility remains a big headache for biotech and pharma companies, resulting in severe delays or even drug development failure. Increasing drug solubility by applying the Dispersome® technology results in enhanced oral bioavailability, lower drug dosing, and better formulations. The Dispersome® technology is a new solubility-enhancing technology and is a compelling alternative to other solubility-enhancing technologies, simply because Dispersome® provide better performance with respect to solubility and bioavailability increase, even of practically insoluble drugs. The technology is based on the use of pharma-grade beta-lactoglobulin (BLG) as a novel pharmaceutical excipient, which stabilizes the drug into an amorphous and highly soluble form. This webinar will give a comprehensive overview on the science behind the Dispersome® technology and showcase different case studies for several programs in the pharmaceutical and neutraceutical space.



Gain insights on the science behind solubility enhancement using the Dispersome® technology.

Learn how the technology can be applied for developing more new drugs into commercial products and allows for improvement of existing drugs.

Understand how the technology can be applied in the nutraceutical space.

Pharmaceutical researchers and scientists

CMC experts on oral drug delivery and formulation

Business development, portfolio management, and technology licensing experts

Chief Scientific Officer
Zerion Pharma A/S



Webcasts

Webinar Date/Time: Tue, Nov 12, 2024 9:00 AM EST


Solving the Insoluble: Webinar on the Science and Application of the Dispersome® Technology

 explores new and emerging technologies, such as mass photometry, machine learning, and AI, and their role in the analytical space for biologic modalities.

https://www.pharmtech.com/pt_w/lifecycle-flexibility



This comprehensive webinar series, focused on continuous manufacturing of oral solid dosage forms, also known as continuous tableting (CT), aims to highlight key opportunities, successes and challenges with continuous tableting. Content of the webinars will cover the role of CM along a wide breadth of the CMC journey, starting with lean and model-based development and concluding with commercial implementation of continuous tableting processes. Each webinar in the series will be presented as a joint talk with participants from innovators, like Merck and Vertex Pharmaceuticals, and Hovione highlighting experiences from each organization and the many advantages of a partnership-based approach. Featured experts will be available to answer audience questions during a live Q&A that will follow each talk.

The webinar series will conclude with a final presentation, shared as a joint talk between GEA and Hovione announcing exciting joint innovations in the CT equipment space along with the latest advances in technology simplification.





One of the main practical challenges for the uptake of continuous manufacturing in the pharmaceutical industry has been managing the complexity of introducing new technology into the daily working culture and practices. Considering oral solid dosages, otherwise defined as continuous tableting (CT), there has been an evolution of the equipment offered by vendors from product-specific needs towards a more generalized platform approach mostly driven by the incorporation of learnings from successful industrialization programs and regulatory approvals. However, pharmaceutical manufacturing continues today to be functionalized for batch-based manufacturing paradigm around the areas of equipment, development workflows, quality system, and regulatory/CMC mindset. The introduction of continuous tableting has been disruptive to a degree, resulting in many aspects of CT being perceived as complex relative to the batch paradigm and this leads to a natural perception of risk and hesitance for widespread adoption.

This third webinar in the series, presented as a joint talk between Hovione and GEA, will highlight some of the key areas Hovione and GEA have identified for CT where complexity is seen as a bottleneck for increased adoption and exchanging it for flexibility. Namely, the key features of the latest version for the Consigma continuous direct compression Flex will be discussed in the context of accelerated development and routine manufacture. In addition, the collaborative efforts from the Hovione-GEA partnership that have yielded opportunities to simultaneously simplify process development in the lab and on the manufacturing shop floor will be shared. This inherent simplification is driven by keeping the complexity “under the hood” and rooted in the latest trends around digitalization and aspects of artificial intelligence.



Learn about a lean approach to process development that leverages the use of process models to inform development of continuous tableting processes. Learn how limited but carefully considered experiments inform powerful models that facilitate development of robust processes.

Learn about important considerations in commercial implementation of continuous tableting. This includes lessons learnt over the course of the lifecycle of such programs starting from installation of the equipment, through qualification, tech transfer and finally during commercial manufacturing.

Hear about experiences with scaling commercial operation including cleaning operations by means of carefully curated case studies.

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

Individuals and organizations who wish to hear peer experience about the implementation of continuous tableting technology – from R&D to commercial manufacturing.

Current and aspiring practitioners of the technology who are curious about process development approaches, and how the use of process models can inform lean development.

Operational excellence specialists who would like to hear about the application of simulation modeling approaches to optimize resource allocation and cycle times.


Fellow Scientist, Technology Intensification
Hovione

Anthony Tantuccio joined Hovione L.L.C. as a Fellow of Continuous Tableting (CT) in the beginning of 2022. He has worked in the drug product development and commercialization area for 15 years with a technical, tactical, and strategic focus on implementing continuous manufacturing for oral solid dosage forms. He has previously worked for Merck (USA) and Bristol Myers Squibb on products supporting early phase clinical manufacturing through process qualification and launch in both batch and continuous paradigms. At Hovione, he is an influencer at the interfaces of the key functional areas which are responsible for implementing and industrializing CT. Finally, he has a passion for data management and analysis, process control and integration, and process analytic technology, all of which are critical considerations when implementing continuous manufacturing.




Senior Director, Technology Management
GEA Group

Dr Jim Holman is the Senior Director for Technology Management for the Pharmaceutical Solid Dosage business within GEA’s Food and Healthcare Division. Jim is responsible for all new product innovations and developments across the continuous, batch, compression and material handling solid dosage business as well as leading industrial and academic collaborations to advanced process understanding in these areas.

Along with his PhD in continuous Twin Screw Granulation and master’s degree in chemical engineering, Jim has over 17 years’ experience focusing upon the development and application of novel and new technologies supporting the manufacture of solid dose products, as well as sustainability projects within the pharmaceutical field. Jim has been involved in multiple industrial collaborations with pharmaceutical companies during his time at GEA and has authored / co-authored over 12 academic publications on the topic of continuous manufacturing.



Webinar Date/Time: Wednesday, July 10, 2024 - 11am EDT | 4pm GMT | 5pm CEST


Simplification of Continuous Tableting for Accelerated Product Development and Lifecycle Flexibility

Hear Key Learnings From Commercial Implementation of Continuous Tableting Processes

https://www.pharmtech.com/pt_w/commercial-implementation

July 10, 2024: “Simplification of Continuous Tableting for Accelerated Product Development and Lifecycle Flexibility”First Session Overiview:



This webinar, jointly presented by speakers from Hovione and Vertex Pharmaceuticals, focuses on key learnings from commercial implementation of continuous tableting processes. Hovione and Vertex have been long-time collaborators in continuous tableting and the talk will draw on the experience of this partnership. The authors’ experience of scaling the team and the operation informed by rigorous time-study data coupled with on-field experience will be shared. A case study on how such time studies can be used to develop scheduling models to inform resource allocation and for a change of line (COL) exercise will also be shared. The use of bespoke tools and aids to improve overall manufacturing cycle times, such as investigation templates, will be discussed. Lastly, both organizations will present perspectives on key learnings from the implementation and commercialization of the technology.



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.


Fellow Scientist, Technology Intensification
Hovione

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.




Scientist, Oral Formulation Sciences
Hovione

Filipe Ataide is a senior scientist in the Technology Intensification group at Hovione, specializing in improving both Spray Drying and Continuous Tableting standards. Prior to his current role, Filipe held several positions in R&amp;amp;D position related to Knowledge Management group and process modeling, simulation and scale-up of chemical processes, developing data integration/visualization tools and mathematical models to monitor and forecast key metrics for the organization. He was also the team lead of the Continuous Manufacturing group in Drug Substance. Filipe Ataíde holds a PhD since 2016 in Chemical Engineering with strong background in modeling, simulation and optimization of chemical processes.




Manager, Technical Operations Drug Product
Vertex Pharmaceuticals

Alexandre Bonnassieux is a Manager in the Technical Operations Drug Product group at Vertex Pharmaceuticals based in Boston, MA. Upon joining Vertex, Alexandre supported the development and technical transfer of new drug products from early clinical to commercial stages as an R&D scientist in the Continuous Manufacturing (CM) group. In his current role as a lead process engineer, he supports all aspects of the commercial production of oral solid dose products which utilize CM equipment trains across the Vertex manufacturing network. Prior to joining Vertex in 2020, Alexandre worked at Pfizer, Inc. as an R&D scientist supporting development and commercialization of drug products, as well as contributing to multiple CM equipment installations at global sites. Alexandre received his Bachelor of Science in Mechanical Engineering from Boston University.


Webinar Date/Time: Thursday, June 20, 2024 - 11am EDT | 4pm GMT | 5pm CEST


Insights from Commercial Implementation of Continuous Tableting: Successes and Challenges of a Partnership-Oriented Approach

Join us for this webinar focused on the development of continuous tableting processes.

https://www.pharmtech.com/pt_w/continuous-tableting

June 20th: “Insights from Commercial Implementation of Continuous Tableting: Successes and Challenges of a Partnership-Oriented Approach”

July 10th: “Simplification of Continuous Tableting for Accelerated Product Development and Lifecycle Flexibility”First Session Overiview:



The first webinar of the series focuses on the development of continuous tableting processes. The webinar, presented as a collaborative talk, shares institutional experience on lean development methodologies, specifically, how a hybrid approach results in development of robust processes while minimizing the use of the active pharmaceutical ingredient (API) and time on the integrated process. The webinar will discuss in detail how carefully curated experiments inform process models, which in turn inform process performance. Success and challenges associated with this approach will be shared via means of case studies focused on loss-in-weight feeders. This webinar will be co-presented by speakers from Hovione and Merck Sharpe and Dohme.




R&D Director, Oral Drug Product Development
Hovione

João Henriques, MSc, is the director of oral drug product development at Hovione R&D, specializing in formulation, particle engineering, and process development of pharmaceutical drug products for oral delivery. With a degree in Biological Engineering from the U. Lisbon, Portugal, João started his professional career in biopharma before joining Hovione in 2008. There, he has worked within Operational Excellence and Process Analytical Technologies groups before starting as a scientist in the Drug Product Development group at R&D, where he gained extensive experience in spray drying and drug product formulations and processes.





Scientist, Oral Formulation Sciences
Merck Sharpe & Dohme

James Tarabokija is a scientist in Oral Formulation Sciences at Merck Sharpe & Dohme, specializing in continuous manufacturing formulation and process development. He is responsible for material sparing lab tests and pilot scale assessments to determine the feasibility of continuous manufacturing for new pipeline assets. James holds a bachelor’s degree in chemical engineering and a master’s degree in pharmaceutical engineering from the New Jersey Institute of Technology.


Webinar Date/Time: Wednesday, May 29th 11am EDT | 4pm GMT | 5pm CEST


Lean Process Development for Continuous Tableting: Foundations of a Hybrid Approach

Join Hovione experts to gain insights on novel formulation development strategies for DPIs and learn how to improve your drug delivery efficiency even at high drug loads

https://www.pharmtech.com/pte_w/dpi-delivery

This webinar will address the most relevant solutions for dry powder inhaler (DPI) development covering both formulation and device development, as well as process optimization and analytical characterization, under an integrated development approach. DPIs are the dosage form of choice for delivering high payloads of inhaled drugs and achieving maximum delivery efficiency to patients. This presentation will focus on new formulation platforms, aiming to address the pharmacokinetics requirements of the target drug and indication, coupled with a new device platform, the Sunriser® DPI. This integrated approach is designed to maximize drug delivery efficiency while maintaining safety, being able to address a diversified array of diseases.



Gain insights on novel formulation development strategies for DPIs, to be able to improve drug delivery efficiency even at high drug loads;

Understand the potential of wet milling and dry milling capabilities for boosting the fine particle dose of DPI formulations;

Discover analytical characterization techniques, for differentiated formulations, to further understand product properties that impact drug delivery and aerodynamic performance;

Understand features associated with a novel high efficiency device platform, the Sunriser® capsule-based Dry Powder Inhaler;

Network with industry peers and experts during the live Q&A session.

Business development, portfolio management and technology licensing experts

Inhalation product development professionals


R&D Manager, Inhalation and Advanced Drug Delivery
Hovione

Susana Saldanha is the manager of formulation and device development team, in the Inhalation and Advanced Drug Delivery Group at Hovione R&D. Susana has over 10 years of experience in formulation development and has supported the development of oral, transdermal, and injectable dosage forms, spanning from early drug product development through product registration to launch.
Susana joined Hovione in 2018 where she focused not only on drug delivery to the lungs but also nasal and ophthalmic drug delivery. She has worked on drug product development projects from early to later stages, ranging from generics to innovative products. Susana holds a PharmD from Faculty of Pharmacy, University of Coimbra.




R&D Manager, Analytical development
Hovione

Sofia Silva is a senior manager in the Analytical development group at Hovione R&D. Sofia has over 15 years’ experience in analytical chemistry development specializing in inhalation drug products, from early to late phase development and drug product launch.
Sofia joined Hovione in 2009 and holds master’s degree in Pharmaceutical Sciences and Pharmaceutical Engineering.

Webinar Date/Time: Wed, Oct 4, 2023 - 11:00 am EDT | 4:00 pm GMT | 5:00 pm CEST | 8:00 am PDT

High Performance Solutions for Dpi Delivery: New Formulation and Device Platforms

Join Hovione expert to understand the advantages of working with a CDMO when implementing continuous tableting (CT) and learn more about the technology-driven advantages of a CT-based program.

https://www.pharmtech.com/pte_w/continuous-tableting

The webinar, focused on continuous manufacturing of oral solid dosage forms, also known as continuous tableting (CT), will introduce the concept of working with a CDMO to develop and launch a CT-based program. The discussion will focus on the business case for continuous tableting in the context of working with a CDMO. Intrinsic technology-driven advantages such as higher product quality, greater supply chain flexibility, opportunity to accelerate time-to-market and ability to implement advanced process control as well as those that manifest from working with an experienced CDMO will be shared.

Learn about important considerations when implementing Continuous Tableting – advantages and challenges.

Understand the advantages of working with a CDMO for a Continuous Tableting based program. This includes new products as well as batch to continuous conversions.

Case studies will be presented showing how big data sets generated in Continuous Tableting enable the implementation of process improvements.

Individuals and organizations who are curious to learn about technology, its fundamental benefits and challenges.

Current and aspiring practitioners of the technology who are interested about the implementation of Continuous Tableting at a CDMO.


Production Senior Manager, Drug Product Continuous Manufacturing
Hovione

 is a Senior Manager at Hovione where he heads the technical services group for Hovione’s continuous drug product manufacturing installation (CT501) in East Windsor, New Jersey, overseeing three technical functions, namely PAT, Process Development and Investigations. In his prior role at Hovione, Dr. Oka was responsible for manufacturing operations in addition to the aforementioned functions, where he successfully led the validation and tech transfer of a commercial program from one of Hovione’s partners to CT501. The program received approval from the US FDA and Dr. Oka was the technical lead for the area during the associated PAI(s). Dr. Oka started his career at Hovione as a process development engineer where he supported the installation and qualification of CT501. Dr. Oka received his PhD in Chemical Engineering from Rutgers University. His thesis focused on continuous powder mixing and granulation and examined the role of continuous manufacturing in enabling direct compression of otherwise directly incompressible formulations. He was part of the team at Rutgers University and NSF ERC-SOPS that helped develop Prezista®, the first FDA approval for a batch-to-continuous conversion of a drug product. Dr. Oka holds a BS in chemical engineering from Mumbai University.

Webinar Date/Time: Wed, Oct 11, 2023 - 11:00 am EDT | 4:00 pm GMT | 5:00 pm CEST | 8:00 am PDT

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