Newsletter | November 16, 2023

11.16.23 -- FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities


ISR Reports has been filling the need for higher-quality market research in the pharmaceutical industry for over 15 years. Utilizing a rigorous primary research methodology, ISR offers off-the-shelf reports as well as unparalleled custom research services. Their website also hosts several resources covering topics such as CDMO and CRO selection, clinical development, drug manufacturing, eClinical technology, decentralized trials, the cell and gene market, and more. Learn more.


FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities

The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.


Understanding The Importance Of Powder And Vapor Containment

Have you considered the safety of your work environment’s air? Across industries, employers are determining how to detect inhalation hazards and, if present, how to protect employees from them.

The Advantages Of Reusable Bulk Systems For Commercial Pharma Shipping

Passive bulk shippers offer pharmaceutical companies solutions to the regulatory hurdles, supply chain disruptions, and logistical challenges inherent to global commercial pharmaceutical transport.

Forget Lean Cleanroom Construction, Practice Lean Installation

Lean construction, as a buzzword, gets a lot of play in the cleanroom industry for good reason. It is an idea that got its start with Toyota in the 1950s to maximize efficiency and eliminate waste in production.

A Proven Platform For Solid-Phase Oligonucleotide Synthesis

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

Driving Sustainability In Spray Drying Through Enabling Technologies

By transitioning to alternative solvents or leveraging process aids, the challenges associated with the use of these chemicals can be addressed, helping create a sustainable and greener footprint.

Designing An Environmental Monitoring Solution For cGMP Manufacturing

Environmental monitoring (EM) should be performed using suitable techniques that meet the needs of the risk assessment. Learn about EM requirements, typical instrumentation features, and more.

Lift Your CLC Expectations To A New Level

Using transposon technology, a substantial improvement can be achieved by pseudo-targeting DNA cargos to integration sites where expression of recombinant proteins is likely to be higher in cells.

Making A Case For A Fixed-Dose Combination Drug Strategy

As patient centricity spurs innovation in drug delivery systems, examine the potential of FDCs to provide convenient dosing and how increased patient compliance is alleviating the cost of healthcare.

Formulation Considerations For Pediatric Populations

By partnering with a CDMO with experience in pediatric formulation, pharmaceutical companies can increase acceptability of their drugs among pediatric patients.

A New Approach To Detecting Drug-Excipient Incompatibility

Explore a systematic thermal analysis approach for detecting drug-excipient incompatibility. The proposed method uses the approach of apparent melting and provides a rapid screening protocol.

Testing Cell-Based Immunotherapeutics For Microbial Contaminants

In this study, two different immune cell preparations were evaluated for their compatibility with the Milliflex Rapid System to establish a USP- and EP-compliant method for rapid sterility testing.

Regulatory And Quality Consulting, Operational Readiness Services

See how CAI aided a manufacturing company in merging food regulations with biopharmaceutical technology, allowing for the quick conversion of a small R&D facility into a GMP-compliant facility.

Water Activity Testing Provides Critical Quality Data For Pharma Products

Controlling water content in oral solid dosage (OSD) products is essential to maintain drug efficacy and safety. Learn about water activity determination of OSD products as well as USP <922>.

Nanoparticle Enabled Formulation And Drug Delivery Solutions

Discover how revolutionary and environmentally sustainable nanoparticle technologies coupled with innovative formulation approaches can address drug solubility issues and add value for patients.

Intensification Strategies For Upstream, Downstream Processes

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.


Blow/Fill/Seal Packaging Systems For Large Volume Nebulizers, Humidifiers

Technology Transfer And Commercial Manufacturing Of Tablets, Capsules

Pharmaceutical Pneumatic Or Vacuum Conveyors

Manufacturing Excellence For Life Sciences

Supporting Bench To Production Applications For Multiple Industries

Trusted End-To-End CDMO Partner For Your Journey

Route Scouting For A Cost-Effective Process Development


Have you heard of Life Science Leader?
Check it out today for access to candid interviews with top-tier executives on how they do business.

Connect With Pharmaceutical Online: