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Troubleshooting Problems Affecting Tooling During Tablet ManufactureUnderstanding difficulties that can occur during manufacture and resolving them quickly can improve oral solid-dosage drug production.
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Modular Approaches to Pharmaceutical Containers Solve Unique ChallengesAdvanced packaging requirements for parenteral drugs are being met with highly tailored solutions.
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Monitoring of transdermal drug delivery in skin using the Renishaw Biological AnalyserDetecting the presence and depth of penetration of drug compounds in skin can prove challenging, current technologies fail to achieve adequate penetration through layers of dermal tissue. In this study, Raman spectroscopy using the Renishaw Biological Analyser - RA816 confirmed the presence of a topical compound in the epidermis and reticular dermis with high specificity and sensitivity.
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A Systematic Approach to Tech Transfer and Scale-UpOnly careful planning can prevent problems that stem from differences between a sponsor’s and a CDMO’s equipment, practices, and culture. This article highlights best practices and case studies.
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Spray drying for enhancing the solubility of poorly soluble drugsSpray drying continues to gain importance as a preferred manufacturing technology for amorphous solid dispersions (ASD). A fast carrier selection allows for a more targeted development process with reduced time to market. EUDRAGIT® polymers have not only been proven to be superior with respect to ASD formations but can also stabilize the amorphous state of the API over storage.
Latest:
Spray drying for enhancing the solubility of poorly soluble drugsSpray drying continues to gain importance as a preferred manufacturing technology for amorphous solid dispersions (ASD). A fast carrier selection allows for a more targeted development process with reduced time to market. EUDRAGIT® polymers have not only been proven to be superior with respect to ASD formations but can also stabilize the amorphous state of the API over storage.
Latest:
Spray drying for enhancing the solubility of poorly soluble drugsSpray drying continues to gain importance as a preferred manufacturing technology for amorphous solid dispersions (ASD). A fast carrier selection allows for a more targeted development process with reduced time to market. EUDRAGIT® polymers have not only been proven to be superior with respect to ASD formations but can also stabilize the amorphous state of the API over storage.
Latest:
Spray drying for enhancing the solubility of poorly soluble drugsSpray drying continues to gain importance as a preferred manufacturing technology for amorphous solid dispersions (ASD). A fast carrier selection allows for a more targeted development process with reduced time to market. EUDRAGIT® polymers have not only been proven to be superior with respect to ASD formations but can also stabilize the amorphous state of the API over storage.
Latest:
Spray drying for enhancing the solubility of poorly soluble drugsSpray drying continues to gain importance as a preferred manufacturing technology for amorphous solid dispersions (ASD). A fast carrier selection allows for a more targeted development process with reduced time to market. EUDRAGIT® polymers have not only been proven to be superior with respect to ASD formations but can also stabilize the amorphous state of the API over storage.
Latest:
Six API Challenges That Could be Slowing Your DevelopmentThe challenges for new drugs looking to enter the market are numerous. But many are self-inflicted – especially in small molecule development. A dangerous perception persists that aside from highly potent APIs, small molecule medications have simple process requirements. The reality, however, is that most APIs will require numerous steps or significant work upfront to avoid development delays, rework or outright failure.
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Is Your In-House Strategy Ready For The Uncertainties Of Biologic Drug Development?The pharmaceutical industry’s past reliance on blockbuster drugs has evolved to include developing drugs that treat the needs of smaller patient populations. These drugs most often come in the form of biologics, which are an increasingly larger share of new drug approvals in the past decade, from 10 percent to 27 percent.
Latest:
Six API Challenges That Could be Slowing Your DevelopmentThe challenges for new drugs looking to enter the market are numerous. But many are self-inflicted – especially in small molecule development. A dangerous perception persists that aside from highly potent APIs, small molecule medications have simple process requirements. The reality, however, is that most APIs will require numerous steps or significant work upfront to avoid development delays, rework or outright failure.
Latest:
Six API Challenges That Could be Slowing Your DevelopmentThe challenges for new drugs looking to enter the market are numerous. But many are self-inflicted – especially in small molecule development. A dangerous perception persists that aside from highly potent APIs, small molecule medications have simple process requirements. The reality, however, is that most APIs will require numerous steps or significant work upfront to avoid development delays, rework or outright failure.
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Applying Lessons Learned from the Semiconductor IndustryApplying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.
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Applying Lessons Learned from the Semiconductor IndustryApplying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.
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The Emergence of Operational Technology as a ServiceThe pressure to improve operational technology performance combined with the rapid pace of technology change is driving adoption of new automation models in pharmaceutical manufacturing.
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The Emergence of Operational Technology as a ServiceThe pressure to improve operational technology performance combined with the rapid pace of technology change is driving adoption of new automation models in pharmaceutical manufacturing.
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The Cost of BrexitDespite preparative work by the bio/pharma industry, any Brexit scenario will result in regulatory implications and increased costs.
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Review by Exception: Connecting the DotsIn batch production, efficient exception management means reducing the time required to identify, review, and resolve process exceptions. Incorporating review by exception functionality within manufacturing execution system (MES) software can streamline biopharmaceutical product release.
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In-vitro Skin Models: Development of Topical and Transdermal FormulationsIn this seminar, we will talk about two different models that can be used for various in-vitro tests. On demand presentation Register free
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Innovating Continuous Twin-Screw Granulation with Foam DeliveryUsing a specific addition method to wet the powder bed in twin-screw granulation using a foam binder improves robustness for continuous solid-dosage drug product manufacturing.
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Foam GranulationThe authors review developments in wet granulation using a twin-screw extruder.
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Building Strategic Relationships with CROsHow to adopt win-win strategies and understand quality agreements for complying with cGMP when building strategic relationships with pharmaceutical contract research organizations.
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Visualization Enhances Facility DesignVisualization using virtual and mixed reality can aid with biopharma manufacturing facility design and training.
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Understanding the Need for Label TrackingTracking and implementing label changes are crucial to the lifecycle of a marketed drug product.
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Taiwan Pharmaceutical AllianceTaiwan Pharmaceutical Alliance provide license in/out, CMO/CDMO, and beyond, for API & FDF. Taiwan is a PIC/S & ICH member. TPA products are launched in the US, EU, Japan.
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AbbVie's Acquisition of Shire Could Save $8 Billion in TaxesAbbVie's relocation to Ireland following Shire's acquisition could lower its annual tax expense by as much as 7% over the next 15 years.
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Scottish Companies Offer Customized Outsourcing Options for Research and ManufacturingTwo contract services providers in Scotland combine innovative business leadership with biotechnology research and development.
