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An understanding-during early development-of the solid form landscape of an API can enhance product quality and manufacturing processes.

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Sourcing hard-to-find ingredients and establishing a reliable supply chain can stretch the resources of a small- to mid-size pharma company.

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Sourcing hard-to-find ingredients and establishing a reliable supply chain can stretch the resources of a small- to mid-size pharma company.

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Sourcing hard-to-find ingredients and establishing a reliable supply chain can stretch the resources of a small- to mid-size pharma company.

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Changing regulatory guidance on generic topical products is expected to lead to an increase in the number of market approvals in the near future.

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Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.

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BENEO is a division of the Südzucker Group, that employs more than 1000 people and has production units in Belgium, Chile, Germany and Italy.

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483s and Warning Letters Point to Inadequate Quality Oversight

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Production and process controls, organization and personnel were the top problems found, while packaging and labelling citations increased in 2017 and 2018.

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A data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.

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Research into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.

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Research into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.

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Research into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.

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DWK Life Sciences, represented by SciLabware (a wholly owned company of DWK Life Sciences), manufacture and supply a complete portfolio of standard and bespoke primary packaging solutions and services that meet and exceed the rigorous requirements and expectations of our customers. From tubular glass vials, stoppers and caps for lyophilisation and diagnostic kits, glass tubes and caps for control reagents, dropper bottles, with dropper assemblies or tips and closures for blood grouping reagents and rare antisera, to additional services including depyrogenation, particulate cleaning and barcoding, we can offer our customers a full primary packaging solution, received ready to use.

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Join this discussion with experts about implementing active air microbial monitoring in sterile cleanrooms. Learn about changes that can save time and money and reduce the risk of product contamination. Live: Wednesday, Nov.13, 2019 at 10am EST | 9am CST | 3pm GMT | 4pm CET On demand available after airing until Nov. 13, 2020 Register free

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At Rite-Hite, we have many solutions for the pharmaceutical industry along with the knowledge and experience to help you address the issues you face with your clean areas. We keep up-to-date on best practices, new design and technology, and the latest trends in the industry.

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Understanding difficulties that can occur during manufacture and resolving them quickly can improve oral solid-dosage drug production.

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Advanced packaging requirements for parenteral drugs are being met with highly tailored solutions.

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Detecting 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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Only 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 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.

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Spray 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.

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Spray 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.

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Spray 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 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.

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The 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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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.

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The 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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The 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.