Newsletter | May 12, 2022

05.12.22 -- Your New EU IDMP Implementation Strategy

 
New Podcast Episode
Featured Editorial
Industry Insights
New Era In Measuring Flow And Shear Properties Of Pharma Powders

Advancements in ring shear cell testing equipment have shortened the process of ensuring the usability of pharmaceutical powders and offer the ability to test more quickly and accurately.

Overcoming Cell Therapy Supply Chain Challenges

For the industry to realize the potential of cell and gene therapies (CGTs), we must develop improved solutions that reliably support the control and transport of critical CGT raw materials and products.

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.

The Benefits Of Aqueous Critical Cleaning In Pharmaceutical Manufacturing

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

Ensuring Safe Handling Of High Potency Products

Due to the high potency of APIs, machine operators must be protected. Yet, humans are a high source of product contamination. In pharma manufacturing facilities, isolators are becoming increasingly important.

Is Your Biologic At Risk For Protein Aggregation? Part 2

The manufacture of sterile injectables is fraught with risk, especially when it comes to protein aggregation in biologic drugs. We offer steps you can take to help prevent aggregation.

The Challenges Of Moving A Bioconjugate From Clinic To Market

Working with a partner that provides a one-stop shop for bioconjugate development and manufacturing helps prevent missteps that threaten delivery of lifesaving drugs to patients who need them.

Bringing Next-Generation Wearable Drug Delivery Solutions To Market

A collaboration has been founded on the principal of bringing to market wearable injection solutions for the simple and efficient subcutaneous administration of large-volume and high-viscosity medications.

Risk Mitigation Of Parenteral Packaging With Container Closure Integrity

Parenteral delivery systems are the highest risk packaging application concerning container closure integrity. Leaks that register in the single micron range can introduce a threat of bacterial ingress.

Five Tests For Pharmaceutical Containment

Here we will analyze and explain the different methods, their reasons, and which would be most beneficial for your first (or next) containment device to ensure personnel protection.

Talent Crossover: Extend Your Workforce Through Supplier Partners

Experts at Sartorius discuss the challenges complex molecules present to drug manufacturers today and the vital role suppliers play in fulfilling talent gaps for their customers.

Leveraging A Biomanufacturing Legacy To Support New Business

Seven diverse experts discuss how Grifols Recombinant Protein CDMO's legacy and recent investments support its future in providing recombinant protein CDMO services.

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.

Ensuring Resilience: How Life Science Is Reshaping Supply Chains In Response To COVID-19

Understand how the supply chain experience, severely affected by COVID-19, involving global workforce disruption, surging demand, and drug shortage notices, is shaping attitudes toward resilience.

Optimizing LC-MS For Biopharmaceutical Analysis

In this e-book scientific experts discuss newer, faster, and more efficacious strategies for peptide mapping and analysis of biotherapeutic products.

Key Considerations When Scaling Up Media Manufacturing

A discussion of the importance of consistent raw materials when transitioning from non-GMP pilot-scale to GMP large-scale media manufacturing and the impact of supply chain instability on a process.

Biologic Drug Product: Formulation, Tech Transfer, Delivery Strategies

Review key considerations for formulation screening of therapeutic proteins and how consistency, planning, and communication are essential for a successful biologic drug product tech transfer.

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