Integrated Development Solutions

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class="et_pb_module et_pb_dcsbcm_divi_breadcrumbs_module et_pb_dcsbcm_divi_breadcrumbs_module_0"> <div class="et_pb_module_inner"> <ol class="dcsbcm_divi_breadcrumbs" vocab="http://schema.org/" typeof="BreadcrumbList"><li class="dcsbcm_divi_breadcrumb" property="itemListElement" typeof="ListItem"><a property="item" typeof="WebPage" href="https://www.catalent.com/"><span property="name">Home</span></a><meta property="position" content="1"></li><span class="dcsbcm_separator"> » </span><li class="dcsbcm_divi_breadcrumb" property="itemListElement" typeof="ListItem"><a property="item" typeof="WebPage" href="https://www.catalent.com/oral-dose/"><span property="name">Oral Dose</span></a><meta property="position" content="3"></li><span class="dcsbcm_separator"> » </span><li class="dcsbcm_divi_breadcrumb" property="itemListElement" typeof="ListItem"><a property="item" typeof="WebPage" href="https://www.catalent.com/oral-dose/development-bioavailability/"><span property="name">Development & Bioavailability</span></a><meta property="position" content="2"></li><span class="dcsbcm_separator"> » </span><span class="dcsbcm_divi_breadcrumb dcsbcm_divi_breadcrumb-active">Integrated Development Solutions</span></ol> </div> </div> </div> </div> </div><div class="et_pb_section et_pb_section_1 et_section_regular" > <div class="et_pb_row et_pb_row_1"> <div class="et_pb_column et_pb_column_3_4 et_pb_column_1 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module mugo_catalent_title mugo_catalent_title_0"> <div class="et_pb_module_inner"> <div class="ctl-title"> <div class="title-image image-large"> <img fetchpriority="high" decoding="async" src="https://www.catalent.com/wp-content/uploads/2018/12/OptiGel-R-Mini-Softgel-Capsules.png" alt="OptiGel Mini Softgel Capsule icon" /> </div> <div class="title-content" style="color:#332a86 !important;"> <h1>Integrated Development Solutions</h1> </div> </div> </div> </div> </div><div class="et_pb_column et_pb_column_1_4 et_pb_column_2 et_pb_css_mix_blend_mode_passthrough et-last-child et_pb_column_empty"> </div> </div> </div><div class="et_pb_section et_pb_section_2 et_section_specialty" > <div class="et_pb_row"> <div class="et_pb_column et_pb_column_3_4 et_pb_column_3 et_pb_specialty_column et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_row_inner et_pb_row_inner_0"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_inner et_pb_column_inner_0 et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_0 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h4>OVERVIEW</h4> <h5><a style="color: #000000;text-decoration: underline" href="#optiform-solution-suite">OptiForm® Solution Suite</a>      <a style="color: #000000;text-decoration: underline" href="#xpress-pharmaceutics">Xpress Pharmaceutics®</a>      <a style="color: #000000;text-decoration: underline" href="#optiform-total-supply">Optiform Total Supply</a></h5></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_0 et_pb_divider_position_ et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_1 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner">You’re faced with many challenges when developing a new therapy: technical, timing, resources, funding, and patient needs. The path to your first in human clinical studies needs to be as fast and efficient as possible, but improper candidate selection, poor formulations, and gaps in clinical dose strategy can lead to unsatisfactory preclinical and clinical data and ultimately to extended timelines and increased costs. </p> <p>A program which includes and seamlessly integrates everything you need to select the right candidate, assess its optimal form, enhance its bioavailability, and deliver cGLP and cGMP materials for testing can save you time and money. Catalent helps its partners turn promising molecules into better treatments with its “Follow the Molecule®” approach that provides accelerated integrated solutions from development to commercial supply.</p> <p>Our integrated solutions include <a href="https://www.catalent.com/oral-dose/development-bioavailability/bioavailability-enhancement/optiform-solution-suite/">Optiform® Solution Suite</a> and <a href="https://clinical.catalent.com/solutions/optiform-total-supply/">Optiform Total Supply</a></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_1 et_pb_divider_position_ et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_2 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a name="optiForm-solution-suite"></a><a class="back-to-top" href="#top">Back to top</a></p> <h4>OPTIFORM® SOLUTION SUITE</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_3 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p>A data-driven parallel screening approach to quickly and efficiently solving complex bioavailability and formulation challenges for poorly soluble compounds. We’ve designed OptiForm® Solution Suite with best practices based on our years of successful development experience to help you get it right the first time. At each step in OptiForm® Solution Suite we have developed ways to accelerate your progress, reduce risks, and get you to key decision points quickly.</p> <p><strong>OptiForm® Solution Suite includes:</strong></p> <ol> <li>Solubility tools and predictive DMPK to move more molecules into development during <a href="https://www.catalent.com/oral-dose/development-bioavailability/preclinical-development/optiform-solution-suite/#candidate-selection">Candidate Selection</a>.</li> <li>Comprehensive <a href="https://www.catalent.com/oral-dose/development-bioavailability/preclinical-development/optiform-solution-suite/#preformulation">Preformulation to characterize</a> the properties and challenges specific to your molecule.</li> <li>Formulation Selection including parallel screening of proven <a href="https://www.catalent.com/oral-dose/development-bioavailability/preclinical-development/optiform-solution-suite/#bioavailability-enhancement-screening">bioavailability enhancement</a> technologies for challenging molecules.</li> <li><a href="https://www.catalent.com/oral-dose/development-bioavailability/preclinical-development/optiform-solution-suite/#formulations-for-glp-studies">Formulation development for GLP toxicity studies</a> to ensure safety and appropriate exposure.</li> <li><a href="https://www.catalent.com/oral-dose/development-bioavailability/preclinical-development/optiform-solution-suite/#phase-i-dose-form-development-amp&-gmp-manufacturing">Formulation & cGMP Manufacturing for Phase I</a> with expert dose development and design services for conventional or enhanced dose forms.</li> </ol></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_2 et_pb_divider_position_ et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_4 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a name="xpress-pharmaceutic"></a><a class="back-to-top" href="#top">Back to top</a></p> <h4>NEW CATALENT XPRESS PHARMACEUTICS™</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_5 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p>A more advanced development offering that integrates formulation development with clinical manufacturing, regulatory support and clinical testing, to help achieve flexible and efficient First-in-Human studies and fast development. At the center of this program is the ability to adjust both formulation and dose based on real-time clinical data, using on-demand manufacturing approaches and adaptive clinical design protocols. This offering helps optimize and accelerate overall development process by reducing stability requirements, which can lead to significant reductions in costs, time and the amount of API necessary.</p> <p><strong>Xpress Pharmaceutics® includes:</strong></p> <ul> <li><a href="https://www.catalent.com/oral-dose/development-bioavailability/xpress-pharmaceutics/#how-it-works">Formulation Development</a></li> <li><a href="https://www.catalent.com/oral-dose/development-bioavailability/xpress-pharmaceutics/#how-it-works">Stability of Generated Products at the Limits of Dosing Range</a></li> <li><a href="https://www.catalent.com/oral-dose/development-bioavailability/xpress-pharmaceutics/#how-it-works">GMP Manufacturing of Bulk, Scalable Intermediate</a></li> <li><a href="https://www.catalent.com/oral-dose/development-bioavailability/xpress-pharmaceutics/#how-it-works">‘On-Demand’ Manufacturing at the Clinical Site</a></li> <li><a href="https://www.catalent.com/oral-dose/development-bioavailability/xpress-pharmaceutics/#how-it-works">Iterative Dosing, Review of Clinical Data, and Decision Making</a></li> <li><a href="https://www.catalent.com/oral-dose/development-bioavailability/xpress-pharmaceutics/#how-it-works">Regulatory Support</a></li> </ul></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_3 et_pb_divider_position_ et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_6 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a name="optiform-total-supply"></a><a class="back-to-top" href="#top">Back to top</a></p> <h4>OPTIFORM TOTAL SUPPLY</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_7 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p>Using an integrated approach and performing activities in parallel, we reduce your overall project risk and timeline to get your promising medications from development to clinic faster. OptiForm<sup>®</sup> Total Supply helps clinical sponsors simplify development, accelerate their timeline and reduce risk through the integration of:</p> <ul> <li><a href="https://www.catalent.com/oral-dose/development-bioavailability/formulation/oral-formulations/">Development formulation</a></li> <li><a href="https://clinical.catalent.com/services/blinding-clinical-manufacturing/">Clinical manufacturing</a></li> <li><a href="https://clinical.catalent.com/services/forecasting-planning/">Demand forecasting and clinical supply management</a></li> <li><a href="https://clinical.catalent.com/services/primary-packaging/">Clinical packaging, labeling, storage and distribution (Phase 1-3)</a></li> </ul></div> </div> </div> </div><div class="et_pb_row_inner et_pb_row_inner_1"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_inner et_pb_column_inner_1 et-last-child"> <div class="et_pb_module et_pb_divider et_pb_divider_4 et_pb_divider_position_ et_pb_space"><div class="et_pb_divider_internal"></div></div> </div> </div> </div><div class="et_pb_column et_pb_column_1_4 et_pb_column_4 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_text et_pb_text_8 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h4>Related Topics</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_9 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a href="https://www.catalent.com/oral-dose/development-bioavailability/bioavailability-enhancement/optiform-solution-suite/">Optiform® Solution Suite</a></p> <p><a href="https://www.catalent.com/oral-dose/development-bioavailability/xpress-pharmaceutics/">Xpress Pharmaceutics®</a></p> <p><a href="https://clinical.catalent.com/solutions/optiform-total-supply/">Optiform Total Supply</a></p> <p><a href="https://www.catalent.com/oral-dose/oral-manufacturing/onexpress/">OneXpress® Solution</a></p></div> </div><div class="et_pb_module et_pb_text et_pb_text_10 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h4>Expert Content</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_11 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a href="https://www.catalent.com/expert-content/development-bioavailability/introducing-catalent-xpress-pharmaceutics-facilitate-adaptive-trials-and-accelerate-phase-1/">Introducing Catalent Xpress Pharmaceutics® – Facilitate Adaptive Trials and Accelerate Phase 1</a></p></div> </div><div class="et_pb_button_module_wrapper et_pb_button_0_wrapper et_pb_button_alignment_center et_pb_module "> <a class="et_pb_button et_pb_button_0 et_pb_bg_layout_light" href="https://www.catalent.com/contact-us/" data-icon="5">Contact Us</a> </div> </div> </div> </div> </div> </div> </div> </article> </div> <footer id="catalent-footer" class="catalent-footer"> <div class="container"> <div class="row sec-main-menu"> <nav class="main-menu" aria-label="Footer menu"> <a href="https://www.catalent.com/expert-content/" title="Expert Content" >Expert Content</a> <a href="https://www.catalent.com/email-subscribe/" title="Subscribe" >Subscribe</a> <a href="https://investor.catalent.com/" title="Investors" >Investors</a> <a href="https://www.catalent.com/careers/" title="Careers" >Careers</a> <a href="https://www.catalent.com/contact-us/" title="Contact Us" >Contact Us</a> <a href="https://www.catalent.com/site-map/" title="Site Map" >Site Map</a> </nav> <nav class="social-menu" aria-label="Social Media menu"> <div class="sec-title">Follow Us. 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