Session Details
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Improve Drug Delivery with Capsule Formulations
In this webinar, formulation scientists and pharmaceutical development specialists will have the opportunity to learn how Lonza’s Capsule Applications Services lab can address drug solubility limitations, develop innovative capsules to tailor drug delivery, and optimize encapsulation processes.
Camille Dumont, Customer Applications Manager, Lonza Capsules & Health Ingredients
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Technology Transfers: Best practices for Optimizing Success and Mitigating Risk
When working with the right partner and network, transferring production between sites allows companies to reap a variety of strategic advantages. Timeline and cost efficiencies can be gained when a trusted CDMO can take a product from development to commercial launch. They can safeguard supply by producing at more than one site, and improve distribution by moving production closer to a critical market. Program costs and risk can be reduced by moving production to sites that are better qualified or better positioned to meet the needs of regulators. But this is not without challenges. Learn how with Thermo Fisher Scientific:
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Uses a network of technical experts and digital innovations for project management to overcome key industry challenges related to tech transfers
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Customizes the approach for the process transfer, stylizing it specific to our customers
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Takes the lead in effectively managing projects through the most complex regulatory strategies by executing consistent, quality manufacturing
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Applies an optimized governance model and an integrated network approach to de-risk and simplify the transition of the program to commercial stage
In this learning lab, we will showcase what differentiates Thermo Fisher Scientific in the technology transfer market and how the power of our network consistently delivers speed through efficiency.
Clarissa van Allen, Global Sr Mgr, Technology Transfer, Oral Solid Dose, Thermo Fisher Scientific
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Polysorbates versus Hydroxypropyl Beta-Cyclodextrin (HPBCD) Stability Comparative Study and their Monoclonal Antibody Stability Benefits
Polysorbates are intensively used in biologics formulation as stabilizers due to their propensity to inhibit aggregation at interfaces but possess low intrinsic stability. In this study, the chemical stability of KLEPTOSE® HPBCDs are compared with polysorbates under various stress conditions. When subjected to heat stress and other chemical stressors – autoclave, light and oxidative stresses – HPBCD remains almost stable while polysorbates show more severe degradation. Further, profiling characterization and degradation analysis reveal that HPBCD chemical structure remains intact while polysorbates undergo significant hydrolytic degradation and oxidation.
Lastly, the physicochemical stability of monoclonal antibody in formulations have been investigated using adalimumab as a model protein. When subjected to light stress, HPBCD-containing formulations show significant decreases in protein aggregation, as well as superior monomer and total protein recovery compared to polysorbate-containing formulations. HPBCD also reduces both agitation and thermal stress-induced protein aggregation and prevents sub-visible particle formation compared to polysorbates
Hailong Zhang, Analytical Research Manager, Applied Science, Roquette
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Bringing Innovative Therapies to Market Through an Enhanced Integrated Approach
In December 2021, Thermo Fisher completed the acquisition of PPD, Inc, a leading global provider of clinical research services to the biopharma and biotech industry. With the addition of PPD, Thermo Fisher will offer a comprehensive suite of world-class services across the clinical development spectrum – from scientific discovery, to accessing safety, efficacy, and health care outcomes, to managing clinical trial logistics, to the development and manufacturing of drug product.
Today a panel of executives from Thermo Fisher will discuss how the addition of PPD’s leading clinical research services differentiates Thermo Fisher and advances our work in bringing life-changing therapies to market, benefiting patients around the world.
Today’s learning lounge will provide insight into how a patient centric mindset influences:
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Drug development and manufacturing decisions
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Clinical trial recruitment, retention and trial management
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End-to-end processes, from early drug development to the patient
Katy Miles, VP, Strategic Accounts, Thermo Fisher Scientific
Daniel Burch, SVP, Global Head of CRG biotech, Thermo Fisher Scientific
Brenda Bruker, Sr Director, Customer Experience Strategy, Thermo Fisher Scientific
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It’s Technology Transfer Gameday, What’s Your Strategy? How are you Getting to Patients Faster while Maintaining Quality?
In this presentation, three of Pfizer CentreOne’s technology transfer MVPs present the playbook for a project accelerated by the pandemic.. The team will discuss the vital moments in the project that enabled success at a pace never seen before, including:
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The value and need for having all parties (SMEs and decision-makers) at the table at every meeting - killing ‘we’ll get back to you’ time!
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Optimizing and streamlining engineering runs
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Better batch strategy
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Orchestration of effort - the need for effective vendor relationships, responsiveness and everyone knowing their role
For each, we’ll answer:
All with the ultimate question in mind: how does this benefit patients?
Jennifer Quint, Senior Manager, Pfizer CentreOne Technical Services
Martin Gonzales, Senior Manager, Pfizer CentreOne Technical Services
Dan Lenz, Manager, Pfizer CentreOne Technical Services
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Today and Tomorrow Challenges – How to Select the Partners in the Situation of Inflation Without any Disruption to Your Services and Production
Healthcare supply chains are under constant pressures, whether its political complexities, the unexpected in everyday operations, and, most recently, a worldwide inflation spiral.
Companies can use these pivotal pressures to build a competitive edge. Now is the time to optimize your supply chain through strategic partnerships, allowing you to refocus your internal resources on business objectives and growth while gaining scale and specialized expertise. Building a strong partnership with your logistics provider can give you access to end-to-end capabilities, an integrated global footprint, and a comprehensive portfolio of healthcare solutions – all of which can help you navigate these challenging times.
Join UPS Healthcare’s Samantha Betancourt, head of Global Strategy and Execution, and Todd Snyder, Vice President, Healthcare Solutions and Operations as they discuss how to select your partners while minimizing disruption to service and production.
Samantha Betancourt, VP of Strategy and Marketing, UPS Healthcare
Todd Snyder, VP, Solutions and Operations, UPS Healthcare, UPS Healthcare
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Impurity Identification and Control Strategy for API Development
A critical component of API process development is achieving a full understanding of the impurity profile while establishing a control strategy. Impurities can be introduced into an API at many stages in the process including through raw materials, product reactions, workup degradation, and isolation conditions.
The ability to identify the origin of the various impurities, understanding their fate, and ultimately how they are purged from the final API are areas in which Grace’s Fine Chemical Manufacturing Services (FCMS) team has extensive expertise. Join our Learning Lab at CPHI Frankfurt to understand how a regimented impurity control strategy guided by research best practices and extensive knowledge of regulatory expectations are critical in API development.
James Springer, R&D Manager, Grace Fine Chemistry Material Services, W. R. Grace
Steve Halpin, Analytical Services Manager, Grace Fine Chemistry Material Services, W. R. Grace
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Excipient Engineering and Design to Improve Processing of Oral Controlled Release Formulations
Hydrophilic polymer matrix systems are widely used in oral controlled drug delivery because of their flexibility to obtain a desirable drug release profile, cost effectiveness, and broad regulatory acceptance. Hydroxypropyl methyl cellulose (HPMC) is the key matrix former used in the majority of formulations. As controlled release formulations continue to evolve, so does the need for more robust and flexible matrix forming polymers. Join this learning lab session to:
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Understand key mechanistic aspects of hypromellose-enabled hydrophilic matrix tablets
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Discover how polymer engineering results in optimized Benecel HPMC grades (new Benecel XR & XRF HPMC grades)
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Learn about the advantages of Benecel DC Hypromellose in flow and loss-in-weight (LIW) feeding for continuous manufacturing compared to regular HPMC grades
Christian Mühlenfeld, Head of Life Sciences R&D, Europe, Middle East and Africa, Ashland
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Reimaging Chemistry to Improve Medicines: High Functional Excipients to increase APIs effectiveness
In today’s world, medical innovations and pharmaceutical technology are essential drivers of human health: they open up the possibility of new treatments and subsequently act as a gateway which allows people around the world to access new medicines, improving their quality of life.
In the production of pharmaceuticals, high-quality ingredients play a crucial role and must meet ever-increasing expectations in quality assurance to guarantee that safe, effective medicines reach the end consumer.
Clariant Health Care is a leading high-quality solution partner for the global pharmaceutical industry, with a strong portfolio of top-performing excipients and active pharmaceutical ingredients (APIs), backed by operational excellence and years of experience in regulatory affairs.
Explore Clariant’s high functional excipients to enable APIs bioavailability enhancement, controlled release, target delivery, stabilization, continuous manufacturing, preservation and viscosity enhancement.
Bhushan Thekedar, Technical Application Manager Health Care, Clariant
Wibke Stelter, Technical Application Manager Health Care, Clariant
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Soft Mist Inhalers (SMIs) Based on Pre Filled Syringes
Resyca, a joint venture between Recipharm and Medspray, is developing a novel type of soft mist inhaler devices, based on an existing primary packaging: glass pre filled syringes. This way we can utilise existing filling lines within Recipharm to do the aseptical filling. The lecture will describe the devices and the typical timelines for clinical and commercial supply. Most pharma and biological companies perform their drug discovery, pre clinical and phase 1 clinical work with nebulisers and liquid formulations. By using a soft mist inhaler device, they can take a shortcut and reach the market sooner and with lower development risks. Resyca's soft mist inhalers have been developed with biologics formulations in mind, being able to deliver milligrams of drug in a single inhalation from a pocket size device.
Bernhard Muellinger, General Manager and COO, Resyca
Wilbur de Kruijf, General Managers, Resyca
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What's the regulatory landscape for OTC products in Europe?
Nutraceuticals and over-the-counter (OTC) products are regulated by EFSA. The European Food Safety Authority (EFSA) states that human intervention studies are ‘central’ to health claim substantiation and are also the ‘top of the hierarchy’ that informs decisions. Just how much data is necessary to deliver a positive health claim opinion and what can we learn from tracking past published opinions of EFSA’s NDA Panel? What are the key deliverables for any human intervention study or package of human studies?
The key takeaways:
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Health claims may not be quite as challenging to achieve as some people may think - as long as you design and deliver a consistent package of good quality human intervention studies.
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Published scientific opinions from EFSA’s NDA Panel covering previous health claim applications offer a great resource to future health claim applicants.
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The principle of GCP (Good Clinical Practice), is vital to delivering a study that will meet the expectations of EFSA reviewers.
Steve Morrison, Regulatory Officer, Atlantia Clinical Trials
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FAMAR Innovates by Launching the First CSCO Business Segment in the Pharmaceutical Industry
FAMAR as a leading European provider of Pharmaceutical Development and Manufacturing Operations announces expansion into the exciting market of full scope service providers, becoming the first Contract Services and Consulting Organization to deliver to the industry a fully integrated service offering, ranging from standard manufacturing operations to every non-core service/activity requiring outsourcing.
Through the commitment of its 1.700 employees, and with a network of 6 production sites, one distribution center and 3 R&D centers in Europe, FAMAR already offers Development and Manufacturing services for more than 1.800 products in 80 international markets, with operational excellence and customer care being at the centre of its long-term business-oriented partnership.
Now, building on its 70 years of industrial CDMO operations, FAMAR innovates again as a CSCO, offering a new, agile approach to the Pharma Consulting and Services business segment, creating solutions and managing firsthand the challenges posed to the modern Pharmaceutical Industry.
Katerina Karapa, Group Quality Assurance Director, FAMAR
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