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Polyethylene glycol (PEG) conjugation is a highly effective technical and commercial strategy to develop macromolecules. The authors explain the benefits and process of PEGylation and how it may be applied to small molecules.

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A reference book omits important information and ignores advanced testing procedures.

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

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Prior to use in a continuous manufacturing system for oral solid dosage forms, loss-in-weight feeders need to be tested and validated to understand the performance capabilities of a given material–feeder combination. In this article, the proper strategy for set-up and optimization of a loss-in-weight feeder is demonstrated for a range of materials. The optimized set-up of the feeders was demonstrated to provide suitable performance for even the most challenging, poorly flowing materials.

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Pelletization, a popular oral drug delivery method in pharmaceuticals and nutraceuticals, offers numerous benefits. This article delves into the critical parameters for formulation development and technological consideration in pelletization, elucidating its significance in advancing pharmaceutical solutions.

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The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.

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Tests evaluated commercial rotary tablet presses to see how effectively they deal with problems such as poor flow, overlubrication, and capping.

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Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. Their digital transformation can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

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Advances in dissolution testing equipment are helping to meet user demands to a certain degree; however, more innovation in the space may be necessary for novel therapies, such as biologics.

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Emerging new technologies and disruptive manufacturing concepts are providing new opportunities for pharmaceutical companies.

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Alec McChesney (BD Director, SCORR Marketing) discusses goal setting and alignment between life sciences marketing and business development teams.

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

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Enterprise process control and management (EPCAM) is a new strategy for healthcare manufacturers based on recent process-control breakthroughs in the electronics industry.

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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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Regulatory, analytical, and process concerns must be taken into account.

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Thursday October 27, 2022 at 11am ET | 10am CT | 8am PT When it comes to freely accessing and sharing lab data, there’s a lot working against you out there. To create infrastructure that truly mobilizes your data and modernizes your lab, you need a new kind of solution.

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Integrating digital technologies into lab environments can ease workflow and enhance data capture for researchers.

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With the increasing need for businesses to reduce costs and demonstrate value, there is a requirement to look at all aspects of bio/pharma drug development and manufacturing to achieve efficiency improvements.

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A new guideline for conducting bioequivalence studies was adopted by the CPMP in January and it becomes fully effective as of August 2010.

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This article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.

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Compliance can be greatly improved by concentrating on the basic elements of CAPA investigations, advises Kate Rice, global quality systems manager, Nelson Laboratories, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.

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This article describes in detail how simulation was used to compare the statistical techniques used to determine out-of-trend (OOT), which is crucial to avoiding out-of-specification (OOS) events for drug substances and products.

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

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With so many outsourcing/insourcing options across drug development workflows, pharmaceutical companies are faced with finding the right partner to fit the needs of their unique molecule. There are criteria to consider when outweighing the benefits and risks associated with buying or building a bioanalytical lab.

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To restrict the use of intentionally added microplastics, the European Chemicals Agency has proposed a restriction dossier that describes various measures aimed at minimizing the use of microplastics in various industrial segments, including pharmaceuticals. In this paper, the authors discuss these restrictions.

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The landscape of cell and gene therapy is rapidly evolving, with increasing approvals for diverse indications. Preserving the integrity and efficacy of cell and gene therapy products is critical. Vial adapters facilitate the transfer of drug product from a vial by securing an efficient connection between the vial and the administration device. Learn more about how sterility and accurate dosing are maintained while preserving stability.

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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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Prior to use in a continuous manufacturing system for oral solid dosage forms, loss-in-weight feeders need to be tested and validated to understand the performance capabilities of a given material–feeder combination. In this article, the proper strategy for set-up and optimization of a loss-in-weight feeder is demonstrated for a range of materials. The optimized set-up of the feeders was demonstrated to provide suitable performance for even the most challenging, poorly flowing materials.

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The move toward using the Digital Application Dataset Integration (DADI) project for the initial implementation of IDMP-based regulatory data submissions offers both opportunities and challenges for pharmaceutical organizations.