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id="ctl06_ctl00_ctl00_divContainer" class="container module default byline-container"> <div id="ctl06_ctl00_ctl00_contentPane" class="content"> <div id="ctl06_ctl00_ctl00_ctl00_divArticleDetail" class="articleModule module"> <div id="ctl06_ctl00_ctl00_ctl00_schemaData" class="schemaData"> </div> <div id="ctl06_ctl00_ctl00_ctl00_divArticleModule" class="articleModule module"><div name="section1835432" class="byline clearfix" id="section1835432"> <div class="ArticleDetailDatePublished"> Sunday, September 1, 2024 </div></div></div> <div id="ctl06_ctl00_ctl00_ctl00_divPaging" class="paging"> </div> <div id="ctl06_ctl00_ctl00_ctl00_divComments"> </div> </div> <div id="ctl06_ctl00_ctl00_ctl01_divContentSharing" class="ContentSharing module"> <div class="contentShareModuleText"> <p></p> </div><span class="tweets"><script type="text/javascript" src="https://platform.twitter.com/widgets.js"> </script><a class="twitter-share-button" href="https://twitter.com/share" 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Streamlining pharmaceutical development is also a key part of this process.</p> <p style="text-align: left;">This article addresses the key motivators of today’s industry and how service providers are adapting their offerings to meet the challenge.</p> <h4 style="text-align: left;"><strong>Speed</strong></h4> <p style="text-align: left;">Time-to-market is a critical factor in the pharmaceutical industry, where delays can lead to substantial revenue losses and missed opportunities within the marketplace.</p> <p style="text-align: left;">To be able to deftly navigate the journey to market, sponsors need established processes, experienced teams, and streamlined workflows. For example, access to high-quality equipment trains, without extended lead times (particularly at a time when access to electronic components and skilled construction resources is a challenge) is not to be underestimated. Additionally, access to regulatory-approved facilities and utilities is vital, ideally without the need for extended design and construction periods.</p> <p style="text-align: left;">Many pharmaceutical companies enter into a build or buy challenge. Both options are costly and hugely impactful for timelines, requiring extensive approvals and qualifications. The additional staffing required to make both solutions fully operational further impacts timelines and budget, making the investment impractical. However, outsourcing facility, equipment, and expertise saves substantial cost and time, helping projects to fully benefit from the availability of a range of technology, GMP floor space, and the knowledge required to make them successful.</p> <p style="text-align: left;">The ability to navigate regulatory pathways and expedite approval processes by adhering to stringent quality standards and regulatory guidelines is crucial. Outsourcing these requirements to an already approved facility with an experienced team can greatly reduce the timeline and provide peace of mind that guidelines are being upheld to the highest regulatory standard.</p> <h4 style="text-align: left;"><strong>Cost</strong></h4> <p style="text-align: left;">Pharmaceutical companies and small biotechs alike are continually looking for potential opportunities to yield cost savings throughout the product lifecycle.</p> <p style="text-align: left;">They want to have the ability to focus on their core competencies: research, development, and innovation. This gives them time to discover ground-breaking therapies, and explore new treatment modalities, and ultimately expand their portfolio.</p> <p style="text-align: left;">Outsourcing manufacturing operations is not only a speedier process, with a significant reduction in capital investments like facilities, equipment, and most importantly skilled technical personnel, but also eliminates the need for expensive (and often higher risk) technical transfers post-development.</p> <p style="text-align: left;">Another challenge facing sponsors is balancing small and large-scale projects. Outsourcing small-scale pharmaceutical commercial manufacturing operations can offer a distinct benefit by avoiding internal competition for resources and focus. Moreover, outsourcing enhances flexibility and cost-efficiency, enabling swift adaptation to market demands.</p> <p style="text-align: left;">Quality and regulatory compliance can also be maintained effectively, as specialized contract partners often excel in niche production (e.g., solubility-enhancing technologies such as spray drying).</p> <p style="text-align: left;">These benefits allow pharmaceutical firms to allocate resources strategically, maintain agility, and uphold quality standards while meeting the diverse needs of both small and large-scale products.</p> <h4 style="text-align: left;"><strong>Flexibility</strong></h4> <p style="text-align: left;">Pharmaceutical development is characterized by dynamic shifts in demand, regulatory requirements, and market trends.</p> <p style="text-align: left;">Outsourcing allows pharmaceutical companies to readily adapt their manufacturing capacities and capabilities to align with specific and evolving needs. This inherent flexibility provides the ability to respond quickly to market demands, scaling production levels, thereby minimizing lead times and optimizing inventory management.</p> <p style="text-align: left;">Engaging with an external development and manufacturing organization, alleviates the need to navigate these factors within their own facility and provides the support of a dedicated experienced team to ensure all factors are considered, met, and completed without having to be managed on-site.</p> <h4 style="text-align: left;"><strong>Risk</strong></h4> <p style="text-align: left;">The pharmaceutical development journey is fraught with various risks, including technical, regulatory, and financial uncertainties, therefore addressing this pain point cannot be omitted.</p> <p style="text-align: left;">Outsourcing manufacturing can play a pivotal role in mitigating some of these risks. These organizations have a deep understanding of regulatory compliance and quality assurance, mitigating the risk of non-compliance and product recalls. They provide the support of dedicated experts in these areas to help guide pharmaceutical companies when challenges arise, avoiding potential delays and ensuring the product being provided to patients is safe and upheld to the highest quality.</p> <p style="text-align: left;">Additionally, their thorough knowledge of manufacturing processes enables them to identify potential bottlenecks or technical issues early in the development cycle, minimizing costly setbacks and allowing sponsors to focus on research, development, and innovation. Engaging with a company that has a high level of manufacturing experience ensures that you benefit from knowledge gained across multiple products. This is often reflected in the ability to foresee potential challenges and provide solutions minimizing the risk before impacting timelines.</p> <p style="text-align: left;">One significant risk area occurs when a product moves from registration scale through late-stage development and onwards, often through scale-up, to commercial supply. Why create an additional risk and transfer a product at this stage? Instead, the benefits of partnering with the right outsourcing partner, with a skilled team who knows the product development history and can technically support a product through its lifecycle are key. Choosing a stable partner who can provide continuity of service for the end-to-end development, manufacture, and commercialization of your product, eliminates risk, and enables seamless technical transfer between teams. This leads to a deeply engrained knowledge of your unique product creating a true partnership and support network to help guide you through all lifecycle stages.</p> <h3 dir="ltr"><span>Author Details </span></h3> <p dir="ltr"><span>Tom Hegarty, Director Operations - Manufacturing - Almac Pharma Services</span></p> <p dir="ltr"><span>Tom Hegarty, Director - Operations – Manufacturing, Almac Pharma Services, has worked in the pharmaceutical industry for over 25 years fulfilling various technical, operational, and managerial roles. During this time, he has worked for large multinational and smaller regional-based companies. His current responsibilities include pharmaceutical formulation development, technical support, and strategic capital investment projects. Throughout his career, he has experience working both as an outsourcing client and as a member of a contract development and manufacturing organization.</span></p> <h3 dir="ltr"><span>Publication Details </span></h3> <address dir="ltr"><span>This article appeared in Pharmaceutical Outsourcing:</span></address><address dir="ltr"><span>Vol. 25, No. 3</span></address><address dir="ltr"><span>July/Aug/Sept 2024</span></address><address dir="ltr"><span>Pages: 32-33</span></address><address dir="ltr"><span><br /></span></address> <div><hr /> <p class="search-out" style="text-align: left;"><a title="Subscribe to our e-Newsletters" href="/PO-Newsletter-Signup/" target="_blank"><strong>Subscribe to our e-Newsletters</strong></a> Stay up to date with the latest news, articles, and events. 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