Newsletter | October 29, 2020

10.29.20 -- How Do FDA, MHRA, & Russia's Ministry Of Health Evaluate & Escalate Inspection Findings?

 
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Continuous Or Batch: Deciding On The Best Solution For Your Oral Solid Dose Product

Gaining a better understanding of continuous manufacturing and its fitness for your oral solid dose (OSD) product could secure more control over the quality and safety of your product and, ultimately, the future of its success.

Is Your Biologics At Risk For Protein Aggregation? Part 3

The main culprit of a failing biologics drug is usually a flawed formulation. In this article, we cover formulation components and how they may affect protein aggregation. Part three of a three-part series.

Six API Challenges And How To Avoid Them

Having a solid understanding of the most common API challenges can help to avoid development delays, rework, or outright failure.

CCI For Combination Products: Assembling The Package Integrity Profile For Autoinjectors

Due to their complexity, combination products, specifically auto-injection systems, present unique challenges in implementing a container closure integrity (CCI) testing strategy. This is further complicated by a pervasive, though diminishing, tendency for companies to consider CCI only at the final product/package life cycle stage, an approach where combination products will highlight the pitfalls.

Aseptic Blow-Fill-Seal: A Sustainable Process For Packaging Pharma Liquids

Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and processes that provide critical advantages for sustainable initiatives.

Mixing Technologies In The Pharmaceutical And Medical Industries

Mixing equipment employed in the production of pharmaceuticals and medical devices deal with a higher level of complexity because their use is more specialized. Not one design fits all.

Three Options To Viral Vector Manufacturing Capacity

A recent virtual think tank focused on the challenges and trends influencing design considerations for viral vector manufacturing facilities and how they can impact companies developing cell and gene therapies.

A Proven, Cost-Effective, Single-Use Powder Transfer Solution

Powder handling processes haven’t kept pace with advances in single-use transfer technologies. This application note posits a better way to bring powders to the hydration process for upstream manufacturing.

Custom Manufacturing: Translating Research Into Product

Custom manufacturing is not “one size fits all” and can be simple or complex, from producing a single component to a final finished product. Learn what capabilities any potential custom manufacturing partner should have to help you make an informed decision.

Paving The Way For Tomorrow’s Medicines

There is a great need for innovative technologies that can improve the success rate for new drug candidates and pave the way for novel therapies to reach the market. Recent advances in nanoparticle engineering technology promise to accomplish precisely this.

The Definitive Guide To Porosity Characterization

This paper takes an introductory look at the techniques used to investigate porosity, the data generated, and their strengths and limitations for specific materials, covering more complex approaches such as the Reverberi method and the application of nonlocal density functional theory (NLDFT) to illustrate the necessity for, and potential benefits of, more advanced analysis.

Analysis Of Laboratory Nitrile Gloves: From Pores To The Surface

The humble rubber glove is usually the first line of protection for any person working with toxic, hazardous, and contagious materials or environments. While everyone agrees on their universal use, very little attention is paid to the type of material, surface topography, or pore size distribution of the glove itself. Here we describe an approach where the use of multiple techniques has enabled a complete physical characterization of the rubber glove material.

Ensuring Everything Is A-OK At AKBA

With IBD and virus filtration making up a significant portion of AKBA’s business, it is critical their equipment and systems meet the strict operational needs of the manufacturing systems used by their clients.

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.

From Molecule To Medicine. Delivered.

To be able to meet the growing needs of patients around the world, a company must have a strategy that can shepherd new biologics therapies throughout the development timeline.

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