Newsletter | September 14, 2023

09.14.23 -- Patent Claims Involving AI After Amgen v. Sanofi


Several advances have already contributed to improvements in viral vector yields. Yet, the CGT sector is still in need of innovations in all aspects of the process to impact product quality. Register today for our next Cell & Gene Live happening September 26 for an interactive panel discussion on how to accelerate scale for viral vector production. Supported by Thermo Fisher Scientific. Register now


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.

Understanding Donor Characteristics To Improve Allogeneic Cell Therapy Outcomes

Here, we discuss efficiencies in donor selection reduce uncertainties about human leukocyte antigen (HLA) and improve patient outcomes.


It's About Time! Automate Biomolecule LC-MS Spectral Deconvolution

We detail the approach we’ve taken to not only speed up the processing of macromolecule electrospray MS data but to build smarter deconvolution workflows.

Innovations In Gene Editing Provide Hope For Patients In Need

Explore how recent CGT breakthroughs hold the potential to create meaningful change for patients living with genetic diseases and the obstacles developers are navigating on the path to commercialization.

5 Tips For Operationalizing Gene Therapy Studies

Discover tips on operationalizing gene therapy studies in order to optimize site selection and patient recruitment and engagement.

Process Platforms Vs. Custom Process Development For Gene Therapies

To address cost, timelines, and manufacturing complexity, many developers utilize turnkey platforms. Can these platforms provide the right solution for successful CMC development?

Overcoming Challenges In Cell And Gene Therapy Containment

Review the hurdles that can slow your time to market, including the challenges in packaging high-value therapies and solutions to help you mitigate risk and simplify the journey.

Find The Right Construction Method For Your Drug Manufacturing Cleanroom

Compare and contrast the different methods available for designing and constructing a cleanroom, including stick-built construction, modular panels, prefabricated modules, and mobile cleanrooms.

Lentiviral Vector Platform: Right The First Time

Leveraging the right LVV manufacturing platform can accelerate timelines, manage costs, and transform product development and potential for clinical success so that therapies reach patients in need.

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.

Lentiviral Vectors: Overcoming Development And Manufacturing Challenges

This executive summary covers a closer look at cell and gene therapy pipelines, choosing a viral vector, including adeno-associated virus, gamma retrovirus, or lentivirus, and current lentiviral trends.

The Right System For High-Throughput, Highly Reproducible RNA Analysis

Review the results gathered from a driver and software system when used to perform data processing on RNA samples separated by capillary electrophoresis (CE).

Effective Enrichment Of Human TILs

Research is being done to study a new method for isolating TILs from human colon tumor xenografts that could be more efficient and effective than traditional methods.

Understand Total Cost Of Ownership For Cleanroom Modality Decisions

Are you seeking guidance to evaluate cleanroom design/built parameters? Learning the total cost of ownership (TCO) and cost-benefit basics is a good place to start.

COGs Process Economics For Autologous Cell Therapy

Analyze the cost distribution over time for autologous CAR T therapy manufacturing using process economics and insights from scientists and R&D. Discover how manufacturers can combat these costs.

Adeno-Associated Virus: Enabling Genomic Medicine

Since the first rAAV-based therapy was approved by the FDA, application of gene therapies utilizing rAAV vectors has exploded and active clinical programs are being fast-tracked for clinical approval.

Transforming T Cell Manufacturing Via Elutriation

Review a T cell manufacturing platform's ability to reduce manufacturing variability by elutriating lymphocytes from apheresis, providing a more consistent cell product for downstream manufacturing.

Inline Monitoring Of hiPSC Growth And Differentiation

Explore a study demonstrating the use of dielectric spectroscopy tools for monitoring expansion and differentiation of hiPSC aggregates in stirred-tank bioreactors.

Gene Therapy: Helping To Bring New Innovations To Light

Explore key considerations for process development, analytical methods, and manufacturing factors to help advance viral vector gene therapies, as well as factors that can help improve CMC outcomes.

Streamline Process Characterization For Successful Validation Campaigns

Explore how a stepwise approach for process characterization can help target the right experimental design and be tailored for different programs based on prior knowledge and experience.


The Cell & Gene Meeting on the Mesa is the sector’s foremost annual conference, bringing together senior executives and top decision makers in the industry to advance cutting-edge research into cures. This year’s program will feature expert-led panels, extensive partnering capabilities, exclusive networking opportunities, and 100+ dedicated presentations by the leading publicly traded and privately held companies in the space. Register today.


Pharmaceutical Automation & Information Technology Services

Non-Viral In Vivo Transfection - Cationic Lipids For LNP Formulation

Efficient Production Of MSCs And Exosomes

Custom And High Throughput Media Development

Xeno-Free, Serum-Free Media For The Cultivation Of Lymphocytes

mRNA Synthesis Reagents And Manufacturing

Tools For Investigating Immune Checkpoint Targets

Propelling Your CGTx Innovation To The Next Stage


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