Newsletter | September 14, 2023

09.14.23 -- Navigating The Murky Waters Of Patent Claims Involving AI After Amgen v. Sanofi



Navigating The Murky Waters Of Patent Claims Involving AI After Amgen v. Sanofi

In May 2023, the Supreme Court issued a ruling on the Section 112 enablement requirement for patents in Amgen v. Sanofi. What does this mean for patent claims involving artificial intelligence (AI) going forward? These Haynes Boone attorneys explain.


The Importance Of Chain Of Custody For Commercial Pharma Distribution

As more new biologics achieve market acceptance, the need for reliable, demonstrable temperature control during shipping has underscored the importance of a robust, reliable chain of custody.

8 Benefits Of Vision Inspection In Manufacturing

Manufacturing requires a high level of precision and accuracy to ensure product safety and efficacy. Here, we explore eight benefits that vision inspection brings to the world of manufacturing.

Intro To USP <1062>: What It Is And Why You Should Use It

Knowing how to use USP <1062> helps manufacturers manage the wide variety of factors that can exacerbate production costs, or result in no product at all.

Prioritize Safety And Mitigate Risk In HPAPI Manufacturing

As highly potent active pharmaceutical ingredients become increasingly common across the industry, it is critical to work with partners who use a risk-based approach to ensure safety and quality.

Highly Potent Active Pharmaceutical Ingredients Containment

Review a full life cycle safety structure that ensures the highest standards of operator protection from single-use flexible film containment systems.

High-Throughput Developability Assessment Enables Efficient Formulation

The biopharmaceutical industry is focused on maximizing the effectiveness of early-stage candidate assessments to predict a molecule’s chances of success before investing heavily in that molecule.

Combat Major Cell And Gene Therapy Manufacturing Regulatory Obstacles

As cell and gene therapies proliferate across the pharmaceutical industry, drug sponsors must determine how to successfully navigate evolving regulations, study design considerations, and a lack of animal models.

Transforming The Pharma Supply Chain

Examine how leveraging a logistics partner with global end-to-end solutions can help avoid costly delays, ensure high product quality, and accelerate impactful solutions for patients worldwide.

A New Approach To Characterizing Crystalline Structure

Learn how the accuracy (melting temperature and heat of fusion) and utility of differential scanning calorimetry data is greatly diminished for materials that undergo apparent melting, and much more.

Computational Fluid Dynamics For Evaluating Cubical Mixer Performance

To evaluate mixing performances across new equipment and consumables to ensure consistency, CFD is invaluable in determining the performance of single-use mixers during process development.

Metered Dry Powder Addition For Continuous And Batch Coating Processes

Twin screw feeders can provide consistent and metered delivery of dry powders directly into coating equipment.

Reaching First-In-Human Trials Faster: Connect With The Right Partner

Assessing partners’ credentials in people, technology, supply chains, and integration makes all the difference as sponsors aim to mitigate risk and streamline processes on the path to commercialization.

Diagnose Absorption Risks To Improve Preclinical And Clinical Outcomes

Physiologically based pharmacokinetic (PBPK) modeling is a powerful tool for clinical trial design that can be leveraged alongside early development experiments to reduce costs and time-to-market.

Flexible Expression Technologies For Mammalian, Microbial Proteins

Drs. Joachim Klein and Rebecca Michael from Lonza Pharma & Biotech answer attendee questions from a recent webinar about Lonza’s options for expressing and manufacturing complex biologic drugs.


Webinar: The Technology Debate — Single-Use vs. Stainless Steel

The shift to single-use technologies has been ongoing for over a decade. Many are still anchored to stainless steel from their capital equipment investments, but is it holding them back? Join us October 4th as we will discuss the multipoint case for adopting single-use technologies throughout the workflow via an economic, operational, and environmental sustainability lens. Click here to learn more.


Bionanoparticle Technology

API And Intermediates

Highly Flexible And Customizable On-Body Delivery System Platform

Automated CCI Testing With MicroCurrent HVLD Technology

Polymer Processing Capabilities

Build A Bioanalytical Strategy That Will Ensure Speed And Agility

Next-Generation Superior Cellulose Membrane

Tablet Manufacturing Training For Manufacturers

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