Newsletter | September 12, 2023

09.12.23 -- Targeting SORT1 To Unlock The Potential Of Peptide–Drug Conjugates In Oncology

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FEATURED EDITORIAL

Targeting SORT1 To Unlock The Potential Of Peptide-Drug Conjugates In Oncology

Peptide-drug conjugates — therapies that generally employ a cleavable or non-cleavable linker to attach a receptor-targeting peptide to a drug payload — have emerged as a potentially viable modality for targeted cancer treatment. How do they work? And how is the glycoprotein SORT1 one of the most promising targets?

Patenting Functionally Claimed Biological Compounds After Amgen V. Sanofi

Snell & Wilmer attorneys discuss the recent SCOTUS decision to uphold the Federal Circuit's holding that Amgen’s patent claims for functionally claimed antibodies were invalid for failing to meet the enablement requirement. The attorneys share what this means for the industry going forward.

INDUSTRY INSIGHTS

Two Steps Forward, One Step Back: IND Submission In Early Development

Product development experts examine the blind spots that can plague early development, as well as which considerations must be accounted for when navigating the path toward an IND submission.

How Buffer pH And NaCl Affect Size Exclusion Chromatography

Using a design of experiments approach, this study describes the effect of buffer pH and NaCl concentration on proteins purified by size exclusion chromatography.

Implement Solvent Recycling To Reduce Waste And CO2 Emissions

Creating a greener manufacturing platform that accommodates solvent recovery and recycling requires the careful consideration of resources, procedures, and partnerships to achieve cost-effective goals.

Diagnose Absorption Risks To Improve Preclinical And Clinical Outcomes

PBPK modeling is a powerful tool for clinical trial design that can be leveraged alongside early development experiments to reduce costs and accelerate timelines to market.

The Flux Performance Of Nanoformed And Untreated PRX Solid Suspensions

Explore the application of in vitro flux assays to nanoparticles, with data on how the apparatus can be utilized to characterize the flux performance of an API formulated as a nanosuspension.

Particle Size Control Through Micronization: Challenges And Solutions

What technical issues need to be addressed if an API is to be successfully micronized? Explore a robust process development strategy that ensures all attributes critical for quality are maintained.

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Intelligent OMICS Ltd In AI Driven Research Collaboration With Janssen

IUPUI Awarded Over $5.5M To Address Chemistry Challenges In Drug Development

Twist Bioscience And Ono Pharmaceutical Partner To Find Novel Antibodies For Autoimmune Disease Treatments

FDA Clearance Of IND Application For AMT-260 Gene Therapy For Refractory MTLE

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ODD Granted To KB408 For Treatment Of Alpha-1 Antitrypsin Deficiency

Amneal Receives U.S. FDA Approval For Lisdexamfetamine Dimesylate

Newly Engineered Bacterial Enzyme Versions Could Make Antibiotics More Potent

SOLUTIONS

DPI Formulation Development And Manufacturing

Serum-Free, Xeno-Free Systems For Culture And Differentiation Of hMSCs

Drug Product Manufacturing