Newsletter | April 7, 2021

04.07.21 -- 11 Critical Steps To Manage Solvents During API Manufacturing

 
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Science Of Scale For Spray-Dried Intermediates

Significant interest has been focused on the science of scale for spray drying. This paper identifies critical steps that can smooth the development pathway, eliminating scale-up headaches down the road.

How Can Working With An Embedded CMO Benefit Your Drug Product?

The right CMO can expedite market launch, and an embedded CMO offers many advantages over other CMO models, including access to the extensive capabilities and know-how of the parent organization.

A Guide To The Cell Line Development Journey

A principal concern of cell line determination is producing the desired protein in a considerable quantity. Understand the technical and regulatory considerations for microbial, mammalian, and yeast platforms.

Establishing A Remote Audit Process As A CDMO

Compliance audits are not immune to the effects of the pandemic. We have been required to adapt quickly to the changing environment to maintain high service levels while protecting employee and client safety.

Empowering Customer Success Through Assurance Of Single-Use Supply

As you consider the future of your product, make sure your supplier is equipped with a single-use technology (SUT) supply strategy that empowers you by securing the single-use products you need.

Meeting Diverse Biologics Pipeline Process Development Challenges

The biopharma manufacturing industry has been evolving at an unmatched pace. Understanding and managing diverse molecule challenges is key to ensuring they reach patients safely and efficiently.  

Dye Ingress For CCIT: A Poor Bet In A High Stakes Game

The dye ingress test method continues to be a widely used test method for container closure integrity. This paper explains why the dye ingress test method is not a suitable approach.

Lung Cancer Treatment By Inhaled Formulations

Explore formulation and manufacturing considerations for the development of dry powder therapeutics, including a case study where topotecan is formulated for dry powder inhalation (DPI) administration to the lung.

5 Common Clinical Supply Chain Speedbumps

Clinical trials are so complex, you need to connect planning and oversight from sourcing to shipping and master such requirements as cold chain, border slowdowns, and data privacy.

Cold-Chain Bioprocessing: Mitigate Risk, Protect Biopharma Products
Many monoclonal antibodies (mAbs), vaccines, and other biotherapeutics must be reliably stored and transported at subzero temperatures, requiring a robust cold chain that continues throughout downstream processing.
Alternatives To In Vivo Assays For Biosafety Testing Of Biologics
Even as alternative methods such as polymerase chain reaction (PCR) and next-generation sequencing (NGS) have emerged, in vivo tests have stubbornly remained a central part of testing. Here we examine current in vivo methods and explore modern alternatives.
Producing Publication-Quality Data With Automated Western Blots

How Simple Western overcomes the challenges and pitfalls associated with traditional Western blots to produce publication-ready data that meet the highest standards of data integrity and rigor.

Bringing The Freezing Of Biopharmaceuticals In From The Cold

In this paper, we review end-to-end freezing solutions that integrate bulk filling, storage, shipping, thawing, and fill/finish operations to minimize risk and preserve product quality.

Fc-fusion Purification Performance: Amsphere A3 vs. Other Protein A Resins

The dynamic binding capacity (DBC) and purification of Fc-fusion and bispecific Ab proteins are compared on A3 and other commercial Protein A resins, with a discussion of the molecular basis for A3’s high affinity for target molecules.

Regulatory Consideration For Biotech Startups

The whirlwind of activity emerging biopharma leaders are seeing for the first time isn’t entirely uncharted territory. Several startup veterans share insight and inspiration on clinical-stage regulatory considerations.

Capture OTC Market Share For Geriatric And Pediatric Patients

This webinar discusses how the unique properties of gelatin have been used to develop chewable softgel formulations for the pediatric and geriatric patient populations. 

AEX Mixed-Mode Chromatography Resin For High Selectivity And Recovery

Dr. Xuemei He introduces the features of the Nuvia aPrime 4A resin, optimized to facilitate selective and reversible binding of molecules for high purity and recovery over traditional chromatography resins.

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