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The COVID-19 pandemic helped to showcase RNA molecules and their therapeutic potential. There were also lessons learned in terms of drug delivery, manufacturing, logistics, and storage.

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Quality is one of the most important components of products in pharmaceuticals. Traditionally, the onus was on the manufacturing function to deliver quality. But what if every single member of the organization was completely focused on customer needs? Big Q, or Quality culture, ensures that quality is up to everyone. DuPont expert will discuss more about how its excipient platform is taking customer cues to implement this total quality focus.

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The authors suggest a design strategy for an aseptic process simulation that focuses on the basic repeating unit of the process, establishing alert and action criteria for the unit itself, and using worst-case simulations to establish routine operational parameters for the manufacturing process.

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Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.

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For pediatric and geriatric patients, fast-dissolving drug-delivery systems provide an easier way to take medications and vitamins. Oral thin films have evolved to provide systemic delivery of active pharmaceutical ingredients for over-the-counter and soon, prescription drugs. The authors review the practical benefits of dissolvable films, their manufacture, and their market potential.

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Best practice methods for the tech transfer of CGTs can increase process and analytics robustness while remaining scalable.

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The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.

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This article describes a validated method, using liquid chromatography/mass spectrometry, for detecting the carcinogenic impurity NDMA (N-nitrosodimethylamine) in ranitidine that meets and exceeds FDA’s limit of detection and limit of quantitation requirements.

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Vendors are finding ways to address the increasingly complex analytical challenges in the biopharmaceutical industry to further biotherapeutic development.

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Study results indicate that fatty alcohols may plausibly enhance the skin permeation of clotrimazole.

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The authors describe the critical aspects of an ideal fermentation services provider.

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In this final part of a series of three articles, the results from experiments involving cohesive materials are discussed in terms of mixing performance, agglomerate comminution, and lubrication of powder mixtures.

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This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.

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In the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using two-level factorial design.

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Colbert Packaging specializes in safe, smart, and sustainable paperboard packaging for the pharmaceutical and healthcare industries, differentiating itself through industry-focused investments and a commitment to environmental responsibility.

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A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.

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This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.

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The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.

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See how Supor Prime filters performed against two comparable products in filtering fluids with antibody concentrations of 70 g/L to 220 g/L. And be sure to request a sample!

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ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products.

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*** Live: Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT *** 2020 Bio/Pharma Virtual Congress: Join Pharmaceutical Technology® and BioPharm International® for this online event that will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry. ***On demand available after final airing until 11/11/2021

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In this paper, the authors introduce a method that combines ion exchange chromatography with an easier-to-perform, simpler one-step post-column derivatization that is selective to nitrite and visible spectrophotometric detection to allow high sample loading volumes without affecting resolution.

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Utilizing integrated active radio frequency identification (RFID) and real-time asset management systems can yield commercial and compliance benefits.

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Though the pharma industry has improved its change management processes, there are still opportunities for improvement.

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The choice of delivery platform for inhaled drug products is contingent on API-related factors, as well as the development stage of the product.

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FDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.

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Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.