{"id":13175,"date":"2020-03-03T16:35:36","date_gmt":"2020-03-03T16:35:36","guid":{"rendered":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/?p=13175"},"modified":"2020-03-10T18:49:23","modified_gmt":"2020-03-10T18:49:23","slug":"can-cloud-computing-help-overcome-some-critical-problems-facing-pharma","status":"publish","type":"post","link":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/can-cloud-computing-help-overcome-some-critical-problems-facing-pharma\/","title":{"rendered":"Can Cloud Computing Help Overcome Some Critical Problems Facing Pharma?"},"content":{"rendered":"

\"CanIn addition to growing regulatory pressures, and 100% raw material identity verification requirements, pharmaceutical and biopharmaceutical manufacturing sites are seeing an increase in new materials for which they must build new, thoroughly validated methods.<\/p>\n

Biopharmaceutical and pharmaceutical manufacturers must follow good manufacturing practices (GMP) and adhere to the U.S. FDA 21 CFR Part 11 requirements<\/a>. These requirements \u201cset forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.\u201d<\/p>\n

As part of their GMP and FDA requirements, biopharmaceutical and pharmaceutical manufacturers must identify and authenticate their raw materials.\u00a0 Compliance and efficiency are top concerns for raw materials managers, but thoroughly analyzing all incoming materials takes time and resources, and methods for validations must be established.<\/p>\n

Method development and validation teams, senior scientists and compliance and quality managers bear the burden of shipping samples around the world for method validation, a challenging, time-consuming and expensive process. However, there are now virtual applications that help enable globalized method validation using cloud computing to overcome many of these critical problems facing pharmaceutical manufacturers.<\/p>\n

As an example, some manufacturers use material identification verification instruments<\/a> utilizing Raman technology. In Raman spectroscopy<\/a>, an unknown sample of material is illuminated with monochromatic (single wavelength or single frequency) laser light, which can be absorbed, transmitted, reflected, or scattered by the sample. Light scattered from the sample is due to either elastic collisions of the light with the sample’s molecules (Rayleigh scatter) or inelastic collisions (Raman scatter). Whereas Rayleigh scattered light has the same frequency (wavelength) of the incident laser light, Raman scattered light returns from the sample at different frequencies corresponding to the vibrational frequencies of the bonds of the molecules in the sample.<\/p>\n

Although this sounds very complicated, a non-expert operator can use a handheld Raman analyzer to accurately verify materials quickly.<\/p>\n

In pharmaceutical manufacturing, Raman spectroscopy is suitable for incoming raw material identity verification, dispensing of materials during API manufacture, and counterfeit identification. Raman analyzer QA\/QC applications include enhanced raw material ID for similar compounds, multiple component ID, and identification and quantification of intermediate and finished products. In PAT, applications include at-line endpoint determination for distillations, reaction monitoring, and powder blending operations.<\/p>\n

The Pharmaceutical Inspection Co-operation Scheme (PIC\/S), Annex 8. PIC\/S Annex 8 requires that individual samples be taken from all incoming containers and an identity test be performed on each sample. This is a major change from the traditional practice of allowing composite sampling of a statistical subset of the batch and identity testing of the single composited sample before releasing the batch to manufacturing. Individual container identity testing puts drastically higher demands on expert analysts\u2019 time. The efficient use of portable Raman analyzers streamlines material verification and makes 100% material inspection cost-effective while maintaining high quality standards.<\/p>\n

When cloud computing is paired with certain Raman analyzers, methods can be validated in the cloud without the need for physical samples, and materials can be tested against a full library with one click. Methods, signatures, and runs that are generated by a pharmaceutical material analyzer can be uploaded to an account, then accessed and reported upon.\u00a0 This allows for standardization of method validation processes across your organization. As a result, pharmaceutical companies can efficiently develop, validate, and manage compliant methods for the manufacturing of safe, quality products.<\/p>\n

With a virtual pharmaceutical material identification application<\/a>, wait times and costs associated with shipping physical materials are reduced, quarantined materials are released into production faster, and methods may be validated centrally allowing sites to focus on production. Users have access to any method or signature uploaded to their account rather than only those stored on an isolated instrument extending materials coverage with minimal invested time.<\/p>\n

Having workflows across your scientific\u00a0organization, streamlining analysis and providing a single source of truth are some of reasons cloud computing can help overcome some of the critical problems facing pharmaceutical manufacturers.<\/p>\n

Cloud computing is a cornerstone of the digital transformation of any lab. It helps drive scientific acceleration by freeing the scientist from manual touchpoints and allowing mobile accessibility to instruments and the data analysis. Thermo Fisher Scientific offers an extensive portfolio of digital capabilities to aid you in your journey of digital transformation. Visit thermofisher.com\/connecteverything<\/a> to learn more.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

In addition to growing regulatory pressures, and 100% raw material identity verification requirements, pharmaceutical and biopharmaceutical manufacturing sites are seeing an increase in new materials for which they must build new, thoroughly validated methods. Biopharmaceutical and pharmaceutical manufacturers must follow good manufacturing practices (GMP) and adhere to the U.S. FDA 21 CFR Part 11 requirements.<\/p>\n","protected":false},"author":38,"featured_media":13412,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_monsterinsights_skip_tracking":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[101],"tags":[1086],"division":[],"class_list":{"0":"post-13175","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-product-news","8":"tag-digital-transformation","9":"entry"},"_selected_authors":"","_selected_reviewers":"","acf":[],"yoast_head":"\nCan 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Analytical testing plays a critical role in verifying product identity, composition, and consistency. Among modern analytical techniques, Raman spectroscopy stands out as a powerful\u2026","rel":"","context":"In "General"","block_context":{"text":"General","link":"https:\/\/admin.acceleratingscience.com\/behindthebench\/general\/"},"img":{"alt_text":"Syringes, injection bottles and tablets lying on the table. Close-up, indoors, view from above. Day light, studio photo. 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Processes that perform consistently at lab scale can shift unexpectedly at production scale. This is\u00a0often because the\u00a0governing physical logic was misunderstood. In geometry-dependent systems, equipment size directly alters heat transfer, mixing, dwell time,\u2026","rel":"","context":"In "Pharma & Biotech Manufacturing"","block_context":{"text":"Pharma & Biotech Manufacturing","link":"https:\/\/admin.acceleratingscience.com\/behindthebench\/pharmamfg\/"},"img":{"alt_text":"Macro Shot of Pink Pills During Production and Packing Process on Modern Pharmaceutical Factory. Medical Drug Manufacturing.","src":"https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/03\/iStock-1465073057_pillmfg.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/03\/iStock-1465073057_pillmfg.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/03\/iStock-1465073057_pillmfg.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/03\/iStock-1465073057_pillmfg.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/03\/iStock-1465073057_pillmfg.jpg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/03\/iStock-1465073057_pillmfg.jpg?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":19658,"url":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/is-raman-spectroscopy-a-better-verification-method-in-pharmaceutical-manufacturing\/","url_meta":{"origin":13175,"position":2},"title":"Is Raman Spectroscopy a Better Verification Method in Pharmaceutical Manufacturing?","author":"Marlene Gasdia-Cochrane","date":"May 5, 2026","format":false,"excerpt":"Article Summary Verification testing is a critical step in pharmaceutical manufacturing, helping to ensure that every product released meets strict safety, quality, and regulatory standards. Verification helps ensure that products contain the correct active ingredients, meet concentration specifications, are free from contamination, and maintain structural and chemical integrity. This process\u2026","rel":"","context":"In "Pharma & Biotech Manufacturing"","block_context":{"text":"Pharma & Biotech Manufacturing","link":"https:\/\/admin.acceleratingscience.com\/behindthebench\/pharmamfg\/"},"img":{"alt_text":"Yellow pill and red check mark sitting on brown wood surface in front of abstract defocused background. Horizontal composition with selective focus and copy space. Front view. Drug approval concept.","src":"https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/04\/iStock-1223991858.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/04\/iStock-1223991858.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/04\/iStock-1223991858.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/04\/iStock-1223991858.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/04\/iStock-1223991858.jpg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/04\/iStock-1223991858.jpg?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":19783,"url":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/what-does-scale-up-look-like-when-volume-is-not-the-goal\/","url_meta":{"origin":13175,"position":3},"title":"What Does Scale-Up Look Like When Volume is Not the Goal?","author":"Marlene Gasdia-Cochrane","date":"June 9, 2026","format":false,"excerpt":"Overview Pharmaceutical scale-up should not always be judged based on increased production volume. While traditional manufacturing focuses on larger equipment and higher throughput, many specialized pharmaceutical programs utilize continuous manufacturing and face different constraints. In these cases, successful scale-up is measured by maintaining process consistency, reproducibility, and control rather than\u2026","rel":"","context":"In "Pharma & Biotech Manufacturing"","block_context":{"text":"Pharma & Biotech Manufacturing","link":"https:\/\/admin.acceleratingscience.com\/behindthebench\/pharmamfg\/"},"img":{"alt_text":"A pill on blue background","src":"https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/06\/iStock-1218800138.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/06\/iStock-1218800138.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/06\/iStock-1218800138.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/06\/iStock-1218800138.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/06\/iStock-1218800138.jpg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/06\/iStock-1218800138.jpg?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":19353,"url":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/manufacturing-strategy-in-pharma-scale-up-vs-scale-out-for-continuous-processes\/","url_meta":{"origin":13175,"position":4},"title":"Scale-Up vs. Scale-Out Strategies for Continuous Pharma Manufacturing","author":"Marlene Gasdia-Cochrane","date":"February 3, 2026","format":false,"excerpt":"As pharmaceutical pipelines evolve, manufacturing strategies are being tested in new ways. Drug candidates are more complex, development timelines are tighter, and expectations for quality and consistency continue to rise. Against this backdrop, one question comes up repeatedly for formulation and manufacturing teams:\u00a0should we scale up, or should we scale\u2026","rel":"","context":"In "General"","block_context":{"text":"General","link":"https:\/\/admin.acceleratingscience.com\/behindthebench\/general\/"},"img":{"alt_text":"Sorting pharmaceutical capsules by a sorting machine on a production line","src":"https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/01\/iStock-1499814881.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/01\/iStock-1499814881.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/01\/iStock-1499814881.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/01\/iStock-1499814881.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/01\/iStock-1499814881.jpg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/01\/iStock-1499814881.jpg?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":19792,"url":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/reducing-discontinuities-in-pharmaceutical-scale-up\/","url_meta":{"origin":13175,"position":5},"title":"Reducing Discontinuities in Pharmaceutical Scale-Up","author":"Marlene Gasdia-Cochrane","date":"June 23, 2026","format":false,"excerpt":"Overview Successful pharmaceutical scale-up depends on more than increased production capacity. Continuity across processing parameters or the geometry of equipment is essential. Scale-up challenges often arise when multiple geometric and operational changes are introduced simultaneously, making it difficult to identify the sources of variability. If the material\u2019s processing environment changes,\u2026","rel":"","context":"In "Pharma & Biotech Manufacturing"","block_context":{"text":"Pharma & Biotech Manufacturing","link":"https:\/\/admin.acceleratingscience.com\/behindthebench\/pharmamfg\/"},"img":{"alt_text":"Multicolored pills on white background","src":"https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/06\/iStock-889516078_pills.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/06\/iStock-889516078_pills.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/06\/iStock-889516078_pills.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/06\/iStock-889516078_pills.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/06\/iStock-889516078_pills.jpg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2026\/06\/iStock-889516078_pills.jpg?resize=1400%2C800&ssl=1 4x"},"classes":[]}],"jetpack_sharing_enabled":true,"jetpack_featured_media_url":"https:\/\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2020\/03\/istock-1153461651_cloudcomputing.jpg","_links":{"self":[{"href":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/wp-json\/wp\/v2\/posts\/13175","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/wp-json\/wp\/v2\/users\/38"}],"replies":[{"embeddable":true,"href":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/wp-json\/wp\/v2\/comments?post=13175"}],"version-history":[{"count":0,"href":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/wp-json\/wp\/v2\/posts\/13175\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/wp-json\/wp\/v2\/media\/13412"}],"wp:attachment":[{"href":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/wp-json\/wp\/v2\/media?parent=13175"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/wp-json\/wp\/v2\/categories?post=13175"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/wp-json\/wp\/v2\/tags?post=13175"},{"taxonomy":"division","embeddable":true,"href":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/wp-json\/wp\/v2\/division?post=13175"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}