Newsletter | January 14, 2021

01.14.21 -- Introduction To ASTM E3263-20 On Qualification Of Visual Inspection For Residues

 
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Pharmaceutical Outsourcing And Planning In A COVID-19 World

Firms need to innovate, change, and have in place quality risk management strategies to develop and implement action plans and knowledge transfer programs to ensure the production of safe and effective medicines in times of staff shortages.

An Executive’s Checklist For CDMO Selection

C-level executives must take an early and active role in vetting potential partners using a deeper understanding of the capabilities and characteristics a CDMO should have to successfully bring a product to market.

Effects Of Deep Cold Storage At -80°C On The Container Closure Integrity Of Sterile Product Vials

Studies have shown that deep cold storage temperatures can introduce risk to the container closure integrity (CCI) of vial-rubber stopper combinations traditionally used to fill sterile pharmaceutical products. The material properties of the primary packaging components at these low temperatures can sometimes result in gaps appearing at the sealing surfaces.

Managing Refrigerated vs. Frozen Drug Product: What’s The Big Deal?

The most common storage is ultra-low-temperature storage, but the fastest growing is cryogenic, in vapor-phase liquid nitrogen. This transition is huge. Chain of temperature and custody data is imperative.

Driving Efficiency And Reducing Waste, New Approaches To Sustainable Chemistry Are Greener By Design

When it was conceived by the Environmental Protection Agency (EPA) more than 30 years ago, “Green Chemistry” was intended to prompt solutions to real-world environmental problems resulting from industrial processes, emissions, and waste. These drivers remain as relevant now as they were then.

Addressing The Evolving Needs Of Variable Drug Delivery Regimens

Pharmaceutical companies continue to advance their clinical development pipelines to develop new and more sophisticated biologics. To be successful, they will need a solution that will enable the delivery and successful commercialization of complex biologics. This article describes a device designed specifically to address the rapidly evolving needs of the pharma industry and meet patient requirements.

The Evolving Role Of The GxP Archivist

Customers and regulators expect the highest level of data integrity, and many organizations rely on an archivist to maintain and protect this most important asset. This white paper will assert that storing GLP data in the cloud is acceptable, provided certain conditions are met.

24-Month Post-Gamma Qualification Of Single-Use pH Sensors In Single-Use Bioreactor, Mixer, And Fermentor Equipment

The purpose of this scientific poster is to determine if Hamilton OneFerm sensors have sufficient gamma stability, low drift, long shelf life, and ease of integration in Thermo Scientific HyPerforma Single-Use Bioreactors (S.U.B.), HyPerforma Single-Use Fermentors (S.U.F.), and HyPerforma and imPULSE Single-Use Mixers (S.U.M.).

Risk Management And The Combination Product Testing Strategy

Understanding combination product risks at the interfaces is critical. Components are often sourced at opposite ends of the globe and are proven to be robust due to investments in research, development, and testing. It is essential to have an equal and complete understanding of all components and how they come together at the interfaces where the risks are hidden.

Single-Use Systems For Storing And Shipping Frozen Drug Materials

The logistics of decoupling drug substance manufacturing from final drug product formulation is now possible using integrated single-use freeze-thaw assemblies that incorporate reliable components.

Aggregation In Pharma: The Future-Proof Solution

This white paper highlights the fact that there are no limits to progress in the pharma industry and provides an insight into the improvement potential of all processes in the supply chain when using aggregation.

Lipid Formulations To Enhance Bioavailability In Early Development

To prevent delays and costly issues during molecular development, it is important to understand potential mechanisms of increased absorption with lipid formulations and the appropriate screening tools.

Navigating Regulatory And Development Milestones

This article addresses how early-stage biotherapeutic companies can avoid common pitfalls as they navigate the funding and regulatory processes to bring novel therapeutics from research to market.

Micelle Characterization By Dynamic Light Scattering: Bringing Viscosity Into The Equation

While performing calculations using the dynamic viscosity of the solvent might be an acceptable strategy for some samples, it introduces a sizeable bias in dynamic light scattering (DLS) results when particles strongly affect the suspension’s viscosity. The following data stress the importance of measuring the dynamic viscosity of samples to obtain accurate particle size results with DLS.

“Smart Devices” vs. “Smart Design” In User-Centric Autoinjector Design

Oval Medical has developed a novel prefilled primary drug container that resolves many drug compatibility and functionality issues associated with the use of traditional glass syringe and rubber plunger technologies.

Recirculation Flow Testing A Biocontainer

A common challenge of using rocker bioreactors in perfusion mode is the transfer of air into the recirculation pathway. Here, a new anchored dip tube designed to prevent the problem is evaluated.

Mixing Selection Considerations For Pharmaceutical Tablet Coating Operations

There are various types of pharmaceutical tablet coatings, including traditional sugar-based coatings, film coatings, and enteric coatings. Whichever type of coating you're manufacturing, a Silverson high-shear mixer will give you a uniform, consistent mix overcoming common processing problems, such as flecking, caused by uneven dispersion of colorant.

Continuous Drug Product Quality By Design (QbD) Modeling

A major pharmaceutical manufacturer needed to improve the quality by design (QbD) modeling process it used in R&D, enabling it to avoid failed batches and deviations in production. A solution allowed them to analyze a continuous pharmaceutical drug product wet granulation step with a design of experiments (DOE) process to determine a multivariate QbD process model. The goal was to apply the multivariate design space to commercial production for process monitoring and identification of deviations.

Ancillary Management: Keep Your Clinical Trial On Track

This e-book analyzes the effect of current trends on the clinical ancillary market. Key industry challenges that clinical trial teams face when managing ancillaries are reviewed and pragmatic solutions are presented.

Improving Manufacturing Outsourcing Relationships

In Q4 2018, ISR asked 100 sponsors who outsource manufacturing about several different scenarios that could potentially improve outsourcing relationships. The data below show how each of the scenarios panned out. A key common element across the most likely scenarios — communication.

Gene To IND In 12 Months Without Increased Risk

Financial pressures, competition, and current global healthcare events are driving the emphasis to move as quickly as possible into the clinic. Learn how to achieve speed while minimizing risk. 

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