Authors

Latest:

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.

Latest:

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.

Latest:

Christian Cobaugh, Eswar Iyer, and Vincenzo Antignani go behind the headlines to discuss a mixture of investment trends, policy realignments, trade and stock recalibrations, and an apparent crusade against vaccines both new and old.

Latest:

Latest:

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.

Latest:

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.

Latest:

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.

Latest:

Change management is central to the evolution of quality control laboratories, but what factors can maximize patient outcomes?

Latest:

Biopharmaceutical manufacturers must consider a surprisingly wide range of factors when deciding where to turn for assistance with cell line development.

Latest:

Accelerate process development with a customizable, liner-based, BIOne single-use solution.

Latest:

A multilayered processing approach ensures safe handling and content uniformity of highly potent APIs.

Latest:

This article explores the evolution of FDA’s approach to inspections of drug and biologics manufacturing facilities during the COVID-19 pandemic.

Latest:

Daniel Galbraith, Chief Scientific Officer (CSO) of Solvias provided a comprehensive picture to Pharmaceutical Technology of the current landscape of cell and gene therapy advancements. The discussion covers important regulatory guidance, technological landmarks, and how Solvias is impacting the current market.

Latest:

Developers might invest in small-scale equipment to produce packaging for stability studies in-house, or they might outsource production. Manufacturers should consider the benefits and risks to both approaches.

Latest:

Challenges that can prevent sponsors realizing the full potential of managed access programs can be overcome by embracing a just-in-time manufacturing strategy.

Latest:

Increased use of nested and ready-to-use primary packaging has resulted in a need for more validation data on container-closure integrity. This article describes efforts to develop these data for new and traditional containers and closures.

Latest:

The authors describe the Piers' catalysts and detail latest progress in olefin-metathesis catalyst technology.

Latest:

Webinar Date/Time: Thursday, September 21, 2023 at 11am ET | 10am CT | 8am PT | 4 pm BST

Latest:

Thursday, September 15, 2022 at 4pm ET | 3pm CT | 1pm PT Partnering with an experienced CDMO can support drug developers’ manufacturing needs and allow them to focus on the core of their developments.

Latest:

The combination of modular facilities and closed processing offers significant advantages in the production of biopharmaceuticals and is becoming a compelling option for manufacturing.

Latest:

Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.

Latest:

***Live: Tuesday, November 17, 2020 at 11am EDT| 8am PDT| 4pm GMT| 5pm CET***Oncology drugs dominate today’s industry pipeline, increasing the pressure on pharmaceutical scientists to get medications to patients as quickly as possible. But does the focus on speed mean sacrifices are made elsewhere in the development plan? Drug developers need to be mindful of the development challenges that come with oncology drug products in order to accelerate to proof-of-concept and onwards towards a successful commercial launch. *** On demand available after final airing until Nov. 17, 2021.***

Latest:

Thursday, September 2, 2021 at 10am EDT | 7am PDT | 3pm BST | 4pm CEST

Latest:

This note describes a rapid method for the evaluation of sediment redispersibility in less than 30 minutes using the Turbiscan technology.

Latest:

Increased use of nested and ready-to-use primary packaging has resulted in a need for more validation data on container-closure integrity. This article describes efforts to develop these data for new and traditional containers and closures.

Latest:

The authors describe the background and applications of fully formulated aqueous shellac for film-coating systems.

Latest:

An ambitious survey of characterization techniques presents current information.

Latest:

The low-volume pharmaceutical industry must adapt Lean Manufacturing tools invented for high-volume, single product industries.