Whitepapers

Kidney transporter models are essential for identifying renal toxicity. Learn how immortalized primary renal tubule epithelial models stably expressing OAT1, OCT2 or OAT3 protein were tested for functionality.

This paper outlines the basics of cleaning validation and discusses the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.

In this white paper we look at reverse engineering existing drug products using Raman imaging.

Download the White Paper and learn how detailed characterization can guide successful development of gene therapy products.

Discussion of the transfer of analytical HPLC methods from a Waters Acquity UPLC system to the Vanquish platform and highlights the impact of column thermostatting.

This application note demonstrates how sensitive UV detection provides quantitation of a genotoxic impurity at low ng/mL level.

The Cubis® II balance series was designed for customizable modularity, which means the user can choose from many hardware and software options for thousands of different configurations. Meet the requirements of the pharmaceutical industry with a combination of the MCA high-end 7” display and specific QApp pharma package, providing all features needed for a full pharma-compliant lab balance system.

• How alternating tangential filtration differs from other perfusion methods • The benefits of alternating tangential filtration

Soft gel capsules are dosage forms that have an oblong and smooth casing that encapsulates a liquid. The soft gel casing (or gel-mass) is formulated by mixing together gelatin (or alternative material) with water, plasticizer and other ingredients. Historically, soft gel casings have been prepared in a batch mixing operation that takes many hours to complete.

ORC International’s report Implications of Inaccurate Forecasting on Biologics Drug Substance Manufacturing explores causes, consequences, and potential solutions to forecasting challenges related to biopharmaceutical drug substance manufacturing. It provides insight and perspective on key themes that emerge from the report, offering additional solutions to prepare for inevitable forecast inaccuracies.

Teams from the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, or JPEO-CBRND, provide continuing support to the Ebola virus outbreak response in the Democratic Republic of the Congo, or DRC, and neighboring countries.

Simplify the scaling of different dosages. Develop on lower dosage tablets to save money. Decrease the need to have multiple tooling sizes in R&D.

The purpose of this document is to serve as a case study where a containment device was designed to facilitate “interim containment”, or containment during the portion of a process where the product isn’t inside the enclosure.

Learn how you can bypass lengthy customizations by deploying a purpose-built LIMS. Pre-configured, pre-validated lab information management systems save time and money, reduce risk, keep you focused, and future-proof your lab.

The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of effectiveness, minimal surface residue, and easier cleaning validation.

Disinfection is not just about the disinfectant. The details, tools and protocols implemented in a facility determine if a disinfection program is successful. This paper reviews the details that are often overlooked but can make a big difference.

Identifying counterfeit drugs has become an area of increasing focus for regulatory authorities and also for pharmaceutical companies. Raman spectroscopy is highly specific and can differentiate between materials with similar chemical structures.

Cancer researchers are challenged by the lack of precise disease models. Genome editing was used to create an isogenic lung cancer cell line that was tested for drug sensitivity.

• Advantages of using an integrated-service provider • Case study: HPAPI monoplant

The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of effectiveness, minimal surface residue, and easier cleaning validation.

• WorkBeads™ 40 TREN is an excellent tool as a guard column upstream protein A resins • WorkBeads 40 TREN removes ~99% of HCD, reduces HCP ~3-fold & removes >93% of endotoxins WorkBeads affimAb in a single step gives a 10-fold more pure mAb eluate than MaSelect SuRe™

This report examines the results of a Pharmaceutical Technology survey on 2018 quality goals and obstacles. The report findings offer insight into how quality teams can impact company-wide performance in 2018.

Use of thermal analysis techniques to characterize pharmaceutical products.

This Rotronic Technical Note covers the basics of how to choose the correct number of sensors and where to place them for a proper cGMP mapping study.

With the product lifecycle moving so fast, many organizations may ask the question, "how can we effectively measure quality?"