Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

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" /> </a> </div> <a href="/doc/do-patient-needs-define-biologic-product-specifications-0001" class="feature-link">Do Patient Needs Define Biologic Product Specifications? </a> <div class="summary ellipsis"><p>Enhanced product understanding acknowledges the technology advancements of the last 25 years and substantially more complex drug modalities.</p> </div> </div> <ul class="secondary list-unstyled clearfix"> <li> <div class="img-canvas"> <a href="/doc/fractional-hiring-at-your-cdmo-okay-with-you-0001"> <img alt="Part-time job, time management, deadline-GettyImages-2165490808" class="lazyload vm-image img-responsive mobile-hide" data-src="https://vertassets.blob.core.windows.net/image/a5d35b00/a5d35b00-067a-4b7c-b700-afc4e946e5f8/245_163-part_time_job_gettyimages_2165490808.jpg" title="'Fractional Hiring' At Your CDMO. Okay With You?" /> </a> <a href="/doc/fractional-hiring-at-your-cdmo-okay-with-you-0001" class="feature-link">'Fractional Hiring' At Your CDMO. Okay With You?</a> </div> </li> <li> <div class="img-canvas"> <a href="/doc/are-cdmo-partnerships-the-answer-to-manufacturing-capacity-issues-0001"> <img alt="Solution-GettyImages-1060711170" class="lazyload vm-image img-responsive mobile-hide" data-src="https://vertassets.blob.core.windows.net/image/b7befdfe/b7befdfe-36a2-4ddd-8272-074e11649bab/245_163-solution_gettyimages_1060711170.jpg" title="Are CDMO Partnerships The Answer To Manufacturing Capacity Issues?" /> </a> <a href="/doc/are-cdmo-partnerships-the-answer-to-manufacturing-capacity-issues-0001" class="feature-link">Are CDMO Partnerships The Answer To Manufacturing Capacity Issues?</a> </div> </li> </ul> </div> <div class="right mobile-hide"> <ul class="list-unstyled"> <li> <a href="/doc/a-snapshot-of-what-pfizer-s-doing-with-teleoperated-robots-0001" class="feature-link">A Snapshot Of What Pfizer's Doing With Teleoperated Robots</a> </li> <li> <a href="/doc/mhra-issues-new-regulation-on-modular-and-point-of-care-manufacture-of-atmps-0001" class="feature-link">MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs</a> </li> <li> <a href="/doc/generic-drug-approvals-in-canada-use-of-a-foreign-sourced-reference-product-as-a-canadian-reference-product-0001" class="feature-link">Generic Drug Approvals In Canada: Use Of A Foreign-Sourced Reference Product As A Canadian Reference Product</a> </li> <li> <a href="/doc/intensifying-downstream-processing-with-magnetic-separation-0001" class="feature-link">Intensifying Downstream Processing With Magnetic Separation</a> </li> <li> <a href="/doc/trends-in-fda-fy-2024-inspection-based-warning-letters-0001" class="feature-link">Trends In FDA FY 2024 Inspection-Based Warning Letters</a> </li> <li> <a href="/doc/ai-performance-management-in-biologic-and-drug-development-0001" class="feature-link">AI Performance Management In Biologic And Drug Development</a> </li> <li> <a href="/doc/february-cdmo-opportunities-and-threats-report-0005" class="feature-link">February 2025 — CDMO Opportunities And Threats Report</a> </li> </ul> </div> </div> </div> <div class="vm-content-item vm-ad "> <div class="row justify-content-center"> <div class="col-auto">  <script> googletag.cmd.push(function () { googletag .defineSlot('/52748101/outsourcedpharma/outph-small-leaderboard', [650,80], 'Ad_outph-small-leaderboard_1_2') .addService(googletag.pubads()); googletag.pubads().enableLazyLoad({ fetchMarginPercent: 50, renderMarginPercent: 0, mobileScaling: 2.0, }); googletag.pubads().enableSingleRequest(); googletag.enableServices(); }); </script> <div id="Ad_outph-small-leaderboard_1_2" class="ad ad-leaderboard "> <script> document.addEventListener("DOMContentLoaded", function () { vertLib.site.Common.setupObserverIntersection("#Ad_outph-small-leaderboard_1_2", () => { googletag.cmd.push(function () { googletag.display("Ad_outph-small-leaderboard_1_2"); }); }); }); </script> </div> </div> </div> </div> <div class="vm-content-item vm-bucket vm-skipcontent"> <h2 class="vm-section-header">GUEST COLUMNISTS</h2> <h6></h6> <ul class="separated-items list-unstyled"> <li class="image-title-summary-container row no-gutters align-items-start"> <div class="col-auto pt-3 pr-3 mobile-hide"> <div class="img-canvas"> <a href="/doc/mhra-issues-new-regulation-on-modular-and-point-of-care-manufacture-of-atmps-0001"> <img alt="UK flag icon with a DNA sign-GettyImages-478760944" class="lazyload vm-image" data-src="https://vertassets.blob.core.windows.net/image/f655ea7e/f655ea7e-0b1d-439e-b4ed-488c7bde8694/150_100-uk_flag_icon_with_a_dna_sign_gettyimages_478760944.jpg" title="MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs" /> </a> </div> </div> <div class="col pt-3"> <div class="summary ellipsis"> <a href="/doc/mhra-issues-new-regulation-on-modular-and-point-of-care-manufacture-of-atmps-0001" title="MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs" class="title-link"> MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs </a> <p>The U.K.'s MHRA has issued a new regulation to allow for decentralized manufacturing of cell and gene therapies (advanced therapeutic medicinal products), describing modular and point of care manufacturing. It becomes effective July 23, 2025.</p> </div> </div> </li> <li class="image-title-summary-container row no-gutters align-items-start"> <div class="col-auto pt-3 pr-3 mobile-hide"> <div class="img-canvas"> <a href="/doc/generic-drug-approvals-in-canada-use-of-a-foreign-sourced-reference-product-as-a-canadian-reference-product-0001"> <img alt="Pills, capsules, canadian flag-GettyImages-481939162" class="lazyload vm-image" data-src="https://vertassets.blob.core.windows.net/image/1fce2ac4/1fce2ac4-79be-40cc-a629-32b657de98d8/150_100-pills__capsules__canandian_flag_gettyimages_481939162.jpg" title="Generic Drug Approvals In Canada: Use Of A Foreign-Sourced Reference Product As A Canadian Reference Product" /> </a> </div> </div> <div class="col pt-3"> <div class="summary ellipsis"> <a href="/doc/generic-drug-approvals-in-canada-use-of-a-foreign-sourced-reference-product-as-a-canadian-reference-product-0001" title="Generic Drug Approvals In Canada: Use Of A Foreign-Sourced Reference Product As A Canadian Reference Product" class="title-link"> Generic Drug Approvals In Canada: Use Of A Foreign-Sourced Reference Product As A Canadian Reference Product </a> <p>Brush up on guidance on how to demonstrate that a foreign-sourced reference drug is acceptable to the Minister of Health as a Canadian reference product for an Abbreviated New Drug Submission and Abbreviated Extraordinary Use New Drug Submission.</p> </div> </div> </li> <li class="image-title-summary-container row no-gutters align-items-start"> <div class="col-auto pt-3 pr-3 mobile-hide"> <div class="img-canvas"> <a href="/doc/intensifying-downstream-processing-with-magnetic-separation-0001"> <img alt="Leads generation, acquisition-GettyImages-1434337901" class="lazyload vm-image" data-src="https://vertassets.blob.core.windows.net/image/eca111b6/eca111b6-e167-478f-9668-13bd763b47ef/150_100-leads_generation__acquisition_gettyimages_1434337901.jpg" title="Intensifying Downstream Processing With Magnetic Separation" /> </a> </div> </div> <div class="col pt-3"> <div class="summary ellipsis"> <a href="/doc/intensifying-downstream-processing-with-magnetic-separation-0001" title="Intensifying Downstream Processing With Magnetic Separation" class="title-link"> Intensifying Downstream Processing With Magnetic Separation </a> <p>A technique used widely in other industries like steel production and wastewater treatment has emerged as rising star within bioprocessing over the last 10 to 15 years.</p> </div> </div> </li> <li class="image-title-summary-container row no-gutters align-items-start"> <div class="col-auto pt-3 pr-3 mobile-hide"> <div class="img-canvas"> <a href="/doc/trends-in-fda-fy-2024-inspection-based-warning-letters-0001"> <img alt="2024 trends-GettyImages-1455849510" class="lazyload vm-image" data-src="https://vertassets.blob.core.windows.net/image/5972ecc5/5972ecc5-227f-49b9-859d-f06d90ceee1f/150_100-2024_trends_gettyimages_1455849510.jpg" title="Trends In FDA FY 2024 Inspection-Based Warning Letters" /> </a> </div> </div> <div class="col pt-3"> <div class="summary ellipsis"> <a href="/doc/trends-in-fda-fy-2024-inspection-based-warning-letters-0001" title="Trends In FDA FY 2024 Inspection-Based Warning Letters" class="title-link"> Trends In FDA FY 2024 Inspection-Based Warning Letters </a> <p>Of the 190 warning letters that the FDA issued to drug and biopharma manufacturers in fiscal year 2024, this article provides a deep dive on trends pertinent to the 111 inspection-based letters. You may be surprised at some of them.</p> </div> </div> </li> <li class="image-title-summary-container row no-gutters align-items-start"> <div class="col-auto pt-3 pr-3 mobile-hide"> <div class="img-canvas"> <a href="/doc/ai-performance-management-in-biologic-and-drug-development-0001"> <img alt="Administration, data center maintenance service-GettyImages-1492649451" class="lazyload vm-image" data-src="https://vertassets.blob.core.windows.net/image/26d80b71/26d80b71-4f9d-4f88-bc19-f3f3049d20ba/150_100-administration__data_center_maintenance_service_gettyimages_1492649451.jpg" title="AI Performance Management In Biologic And Drug Development" /> </a> </div> </div> <div class="col pt-3"> <div class="summary ellipsis"> <a href="/doc/ai-performance-management-in-biologic-and-drug-development-0001" title="AI Performance Management In Biologic And Drug Development" class="title-link"> AI Performance Management In Biologic And Drug Development </a> <p>Life cycle maintenance is essential in AI-driven drug development. Regulators recommend continuous updates to AI models to monitor and adjust for data pattern changes.</p> </div> </div> </li> <li class="image-title-summary-container row no-gutters align-items-start"> <div class="col-auto pt-3 pr-3 mobile-hide"> <div class="img-canvas"> <a href="/doc/february-cdmo-opportunities-and-threats-report-0005"> <img alt="plus and minus sign-GettyImages-1041731818" class="lazyload vm-image" data-src="https://vertassets.blob.core.windows.net/image/485205e4/485205e4-c606-446e-ab42-c5e2fabbf2b6/150_100-plus_and_minus_sign_gettyimages_1041731818.jpg" title="February 2025 — CDMO Opportunities And Threats Report" /> </a> </div> </div> <div class="col pt-3"> <div class="summary ellipsis"> <a href="/doc/february-cdmo-opportunities-and-threats-report-0005" title="February 2025 — CDMO Opportunities And Threats Report" class="title-link"> February 2025 — CDMO Opportunities And Threats Report </a> <p>Each month, Outsourced Pharma works in conjunction with <a href="https://www.globaldata.com/industries-we-cover/pharmaceutical/" target="_blank">PharmSource</a>, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.</p> </div> </div> </li> <li class="image-title-summary-container row no-gutters align-items-start"> <div class="col-auto pt-3 pr-3 mobile-hide"> <div class="img-canvas"> <a href="/doc/challenges-in-manufacturing-til-for-clinical-trials-0001"> <img alt="lymphocytes and biological immune system-GettyImages-2159125883" class="lazyload vm-image" data-src="https://vertassets.blob.core.windows.net/image/86506cda/86506cda-a37f-45d1-b64c-7c5a0ebb0d3d/150_100-lymphocytes_and_biological_immune_system_gettyimages_2159125883.jpg" title="Challenges In Manufacturing TIL For Clinical Trials" /> </a> </div> </div> <div class="col pt-3"> <div class="summary ellipsis"> <a href="/doc/challenges-in-manufacturing-til-for-clinical-trials-0001" title="Challenges In Manufacturing TIL For Clinical Trials" class="title-link"> Challenges In Manufacturing TIL For Clinical Trials </a> <p>Tumor-infiltrating lymphocyte cell therapy shows promise for treating solid tumors, but its complex manufacturing profile brings a unique set of issues. 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(Check all that apply.)</div> {{@each(it.personas) => pers, index}} {{@if (index%2 === 0)}} <div class="row pl-3 vm-checkbox-container"> {{/if}} <div class="col-md-6 text-capitalize form-check"> {{@if (pers.isSelected)}} <input type="checkbox" name="personas" checked="checked" value="{{pers.id}}" class="form-check-input"/> <label class="form-check-label">{{pers.text}}</label> {{#else}} <input type="checkbox" name="personas" value="{{pers.id}}" class="form-check-input"/> <label class="form-check-label">{{pers.text}}</label> {{/if}} </div> {{@if (index%2 !== 0 && index > 0)}} </div> {{/if}} {{/each}} {{@if (it.personas.length%2 === 0)}} </div> {{/if}} </div> </div> {{#elif (it.subscriptions.length)}} <div class="pt-3">You may also be interested in these industry newsletters:</div> <div class="p-4 input-container"> {{@each(it.subscriptions) => sub, index}} {{@if (index > 0)}} {{@if (index%2 !== 0)}} <div class="row pl-3 vm-checkbox-container"> {{/if}} <div class="col-md-6 text-capitalize form-check"> {{@if (sub.isSelected)}} <input type="checkbox" name="subscriptions" checked="checked" value="{{sub.id}}" class="form-check-input"/> <label class="form-check-label">{{sub.text}}</label> {{#else}} <input type="checkbox" name="subscriptions" value="{{sub.id}}" class="form-check-input"/> <label class="form-check-label">{{sub.text}}</label> {{/if}} </div> {{@if (index%2 === 0)}} </div> {{/if}} {{/if}} {{/each}} {{@if (it.subscriptions.length%2 === 0)}} </div> {{/if}} <button id="selectAll" type="button" class="btn btn-link pl-0 pt-2">Select All</button> </div> {{/if}} <div class="row justify-content-end"> <div class="col-12"> <button type="submit" class="btn vm-alt-button mt-4"> <span class="vm-button-text">Finish</span> </button> </div> </div> <input type="hidden" name="OnlineId" id="OnlineId" value="{{it.onlineId}}" /> </form> </script> <script id="loginTemplate" type="text/x-template"> {{@if (it.message)}} {{@if (it.hasError)}} <div class="alert alert-danger d-flex flex-row p-2 m-0"> {{ #else }} <div class="alert alert-warning d-flex flex-row p-2 m-0"> {{/if}} <i class="fa fa-info mr-2 mt-1"></i> <div>{{it.message | safe}}</div> </div> {{/if}} <form method="post" action="/user-subscription/login" id="loginForm" class="vm-form-alt"> <div class="row"> <div class="form-group col"> <label for="Email">Email</label> <input type="text" class="form-control form-control" id="Email" name="Email" maxlength="100" value="{{it.email}}" /> </div> </div> <div class="row"> <div class="form-group col"> <label for="Password">Password</label> <input type="password" class="form-control form-control" id="Password" name="Password" /> </div> </div> <div class="row"> <div class="form-group col"> <small> <a href="/password/forgotpassword">Forgot your password?</a> </small> </div> </div> <div class="vm-oauth-providers"> <span class="small mb-4">... or you can:</span> <a class="btn btn-lg rounded-circle" role="button" href="/user-oauth/login?oAuthType=Google&source=user-sub"> <i class="fa fa-google" aria-hidden="true"></i> </a> <a class="btn btn-lg rounded-circle" role="button" href="/user-oauth/login?oAuthType=Facebook&source=user-sub"> <i class="fa fa-facebook" aria-hidden="true"></i> </a> <a class="btn btn-lg rounded-circle" role="button" href="/user-oauth/login?oAuthType=LinkedIn&source=user-sub"> <i class="fa fa-linkedin" aria-hidden="true"></i> </a> </div> <div class="row justify-content-end"> <div class="col-12"> <button type="submit" class="btn vm-alt-button mt-4"> <span class="vm-button-text">Sign In</span> </button> </div> </div> <input type="hidden" name="JobTitle" id="JobTitle" value="{{it.jobTitle}}" /> <input type="hidden" name="Company" id="Company" value="{{it.company}}" /> <input type="hidden" name="OnlineId" id="OnlineId" value="{{it.onlineId}}" /> <input type="hidden" name="Privacy" id="OnlineId" value="{{it.privacy}}" /> </form> </script> <script> window.userSubSettings = undefined; </script> </div> </div> </div> </div> <script id="modalTemplate" type="text/x-template"> <div class="modal fade" id="{{ it.id }}" role="dialog" tabindex="-1" data-keyboard="false" data-backdrop="{{ (it.backdrop || 'true') }}"> <div class="modal-dialog vm-modal"> <div class="modal-content"> {{ @if(it.title) }} <div class="modal-header no-gutters justify-content-between"> <div class="col"> <h2>{{ it.title | safe }}</h2> </div> <div class="col-auto"> <div class="vm-ajax-loader"><span></span></div> <button type="button" class="close" data-dismiss="modal" aria-hidden="true">×</button> </div> </div> {{ /if }} <div class="modal-body">{{ it.body | safe }}</div> {{ @if (it.hideFooter !== true) }} <div class="modal-footer"> <div class="row justify-content-end"> <div class="col-12"> <button type="button" data-dismiss="modal" class="btn vm-button">Close</button> </div> </div> </div> {{ /if }} </div> </div> </div> </script> </body> </html>

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