Newsletter | July 26, 2024

07.26.24 -- How Eli Lilly's Making Peptides Faster And More Reliably

INDUSTRY INSIGHTS

Every Component Counts In Single-Use Systems For Storing And Shipping

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.

Top 10 Most Cited QSR Clauses In FDA FY2023 Medical Device Inspections

By proactively addressing recurring deficiencies in design controls and risk management, manufacturers can ensure FDA compliance and prioritize patient safety and device effectiveness.

The Path To Self-Administration: Moving From PFS To Auto-Injector

Review advice to pharma companies on three key areas of auto-injector device development: patient-centered design, container and device considerations, and manufacturing partner selection.

Basic Principles Of Freeze-Drying

Here, we provide a lyophilization process overview that dives deeper into freeze-drying and reviews drying pressure, temperatures, cycle optimization, scale-up considerations, and storage.

Tablet Tooling Nutraceutical Products

How can you reduce tooling wear and problems caused by abrasive ingredients during your tablet manufacturing process?

Five Steps To Packaging Quality Assurance For Liquid Pharmaceuticals

Find solutions to five key challenges of quality assurance and information to help you identify which product inspection products can best support your application.

You Had Me At Flow: The Shift From Batch To Continuous

The pharmaceutical industry is undergoing a transformative shift from batch to continuous flow processes, enabling enhanced efficiency and safety as well as improved sustainability.

Prioritize Solvent Recycling And Recovery To Realize Your Green Goals

Building more sustainable practices across the pharmaceutical industry takes a collaborative and transparent effort. One leading CDMO is leveraging its solvent recovery efforts to yield major strides.

A New Approach To Isolator Decontamination

How can you address the decontamination challenges associated with isolated fill-finish operations? New innovations are being implemented to ensure superior sporicidal reduction and operational safety.

Liquids, Soft Foods As Vehicles For Enteric Coated Bead Drug Product

Take a deeper look at the challenges and solutions involved in creating a child-friendly medication delivery system, and learn about the importance of collaboration and meticulous scientific processes.

Key Equipment Sourcing Strategies For CMOs

Using a contract or toll manufacturer in the specialty and custom chemical industry can be viewed as a quality and supply chain risk. Discover what equipment sourcing strategies can mitigate those risks.

How Drug Delivery Is Enabling A Clinical Trial For Glioblastoma

Examine highly promising in-vivo data, enabled by a nanoformed drug product for the treatment of glioblastoma multiforme (GBM).

Biological Indicators - Population Assay

Watch this discussion to learn about resistance testing and using it to control and monitor incoming biological indicators (BI).

Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics

Explore the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.

FEATURED EDITORIAL

How Eli Lilly's Making Peptides Faster And More Reliably

Three company leaders answer questions about the IE2b project, which is receiving an ISPE 2024 Facility of the Year Award for its ingenuity of complexity.

SOLUTIONS

Manipulator System For Robotic Pharmaceutical Filling And Inspection

The First BioPharma Life Cycle Management Platform

Quality Management And Compliance Consulting

UF/DF TFF System For Oligo Purification And Product Concentration

Affinity Chromatography Resin For Purifying Recombinant Proteins

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