04.06.21 -- Marketo Split-Test Test 3

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.

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 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.

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.

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.

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.  

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.