12.06.22 -- 1 Year Out, Where Do We Stand On DSCSA Implementation?

Find out what steps you can take to reduce the risk of component shortages in medical devices and for the manufacture of drugs and biologics, and their consequences.

Drug manufacturers seeking alternative methods for a safe and reliable approach to drug delivery should consider blow/fill/seal technology, as it offers several benefits over traditional glass packaging.

Facilitating oligonucleotide synthesis with state-of-the-art equipment and process support is critical to maximizing oligo production and achieving consistency at scale.

As we balance the time-to-market and risk for novel therapies, we must anticipate changing needs for combination device development, highlighting the technological paradigm shift.

Explore some of the most relevant engineering activities that are necessary to successfully transfer a product from a vial into a prefilled syringe presentation.

Explore targeted guidance for overcoming challenges with orphan drugs and ensuring that enough high-quality data are generated from the start of your orphan drug program to guide evidence-based decision-making.

A variety of concerns — underscored by supply chain disruptions driven by the COVID-19 pandemic — are pushing companies to redraw global supply chains to resume more domestic manufacturing.

Follow our discussion on non-heat-sensitive aqueous liquid products sterilized and the use of the overkill method and bioburden/BI method.

A recent webinar described the complex effects of combining excipients in a formulation and the importance of determining optimal concentrations and processing conditions for lyophilization of protein formulations.

When replacing your CRO becomes the only feasible option, a partner experienced in such transitions — as well as sensitive to the impact on your timeline and costs — is invaluable.

In a recent webinar, experts from Ajinomoto Bio-Pharma Services explored the necessary components of a tech transfer for LNP-based drugs, including the outsourcing strategies needed to avoid pitfalls.

Microencapsulation, wherein particles are co-formulated with polymers or other excipients to improve palatability, modify release rate, or enhance bioavailability, possesses advantages for many pharmaceutical applications.

This guide explores the regulatory strategy considerations sponsors should bear in mind when working with global regulation agencies, with a focus on the development of drug and biologic products.

Protection against counterfeit products is becoming more important to international pharma companies. Datamatrix stations allow August Faller KG to offer a range of track-and-trace and serialization services.

A range device assembly machine with the ability to implement several auto-injector formats, and allow rapid, tool-free changeover time of less than two hours, provides a solution for PCI Pharma Services.

Get to market quicker with the right sourcing and supply chain strategies for your cGMP chemicals.

Explore how to assess the risks of properly developing therapeutic drug candidates, including employing computer modeling tools, novel cell-based assays, and a full economic viability appraisal.

Launching a large molecule in one format and then switching the delivery format often transpires as a lifecycle management strategy for cost efficiency, supply chain continuity, and patient benefit. 

In this webinar you will learn more about the advantages of the laser balancing technology for microscopy and mass spectrometry and how to achieve the optimal results for your application.

How do you know if an intensification approach will provide advantages? Three process intensification experts show how different intensification approaches affect outputs using different scenarios.

Drug developers must successfully navigate the path to market, under the growing pressures of regulation and competition, and while carefully managing technical and financial risk.

Biopharma products in development continue to increase in complexity, which poses a challenge for pharmaceutical companies looking to improve speed and efficiency of biologic development.