Welcoming The “Era Of ADCs”

In an episode of The Business of Biotech podcast, Dr. Loretta Itri sat down to explore antibody-drug conjugates as transformative treatments for a range of intractable diseases.

Trends In Next-Generation Delivery Technologies

Learn how lipid nanoparticles are enabling a new generation of engineered cell therapies with a push toward more complex cell engineering and gene editing for allogeneic therapies.

Genome Editing Using mRNA-Lipid Nanoparticles For CAR T Cell Therapy

Gene delivery platforms must support a diversity of genetic engineering strategies for genomic medicine development. Learn how lipid nanoparticles can accelerate development from discovery to scale-up.

Legal And IP Protection For New Biotechs

Want to ensure you've got your biotech legal, IP, and patent bases covered? Join Business of Biotech host Matt Pillar and BlueSphere Bio CEO and biotech legal expert Keir LoIacono on 11/13 for the live, interactive, and FREE digital event Legal And IP Protection For New Biotechs. 

How To Develop A Scalable AAV Process, From Start To Finish

We present highlights from a process that has been developed – and continues to be refined – by Cytiva scientists. These insights are framed around common challenges in AAV development and production.

Improving The Characterization Of Gene Therapy Products

The analysis of over 10 variant callers and other bioinformatics tools for viral variant detection are discussed to better understand how the outcomes can improve gene therapy product characterization.

Preformulation Of Excipients In Biologics Development

Most of the instability problems of a drug product come from excipients, in particular, they come from impurities in excipients. Those issues are best cleaned up in the preformulation period to determine excipient compatability.

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 cell therapy manufacturers can combat these costs.

What The ICH Q5A Virus Safety Guidelines Mean For Your Cell & Gene Therapy Product

Explore Cell & Gene therapy (CGT) products now within scope of the ICH Q5A guidance, technologies that can replace traditional testing strategies, viral clearance studies expected for vector products, and more.

Oligonucleotide Manufacturing: How To Get A Strong Start

If you’re developing an antisense oligonucleotide, siRNA, or other oligonucleotide therapeutic, you’re aware of their potential. Explore 5 keys to success for oligo synthesis, scale-up, and manufacturing.

Determining RNA Integrity And Purity By Capillary Gel Electrophoresis

To ensure mRNA product quality, it's important to confirm the integrity of the RNA. Examine the results of a study challenging the performance of the CGE method in assessing mRNA integrity and purity.

Lipid Nanoparticle Compositional Analysis By UHPLC-CAD

Explore results generated from an internal study using a proprietary mRNA-LNP formulation and UHPLC-CAD, a powerful technique for the analysis of compounds that do not contain chromophores.

Establishing Analytical Methods For mRNA-Based Therapies

Here, we provide a detailed description of assays for sequence identification and LNP composition, two CQAs of mRNA-LNP products, that support the development of safe and effective mRNA therapies.

The Global Market For Generic Sterile Injectables To Double In Value By 2032

According to new analysis at insightSLICE, the global generic sterile injectable market size was estimated to be $79.95 billion in 2022 and is expected to grow to reach $159 billion by 2032. What are the key factors and trends driving this growth? This author shares the key data-led insights.

AAV Full/Empty Capsid Separation Using Mechanistic Modeling

In this study, we used mechanistic modeling to investigate how AAV-resin interactions are affected when MgCl₂ is used as an elution additive.

5 Characteristics Of The Automated Microbiology Lab Of The Future

The modern microbiology laboratory is starting to look very different from the laboratory of 10 years ago, and it will continue to evolve in the next few years. There are a number of innovations being implemented now or are in progress that can signal the path that many microbiology laboratories will follow.

The Global Market For Generics & Biosimilars Through 2032

According to new market research from insightSLICE, the global market size for generic drugs (including biosimilars) was estimated to be $566.85 billion in 2022 and is expected grow at a CAGR of 5.7% from 2023 to reach a value of $990 billion by 2032. This article shares key insights from the market research.

Dispelling 4 Common Myths Of Data Quality Governance

Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.

Biotech’s Market Outlook In 2023 & Beyond

This article discusses three key themes in 2023 that are likely to have an outsized impact on biotech companies as well as the notable longer-term trends to watch over the next few years.

Streamlining The Integrity Testing Process – From Test To Report

Discover a digital transformation solution that provides first of its kind data analytics for filter integrity testing. The software helps operators and supervisors reduce time lost through review processes.

After Decades Of Biomanufacturing Workforce Development, What’s Next?

We have seen exponential growth of the biotech industry in recent decades. Companies have struggled to find qualified workers. To close that workforce gap, we need to leverage the lessons from successful biomanufacturing training programs and consider new approaches.

Establishing A Robust Workflow To Identify High-Performing Clones

Cell line development is a complex, labor intensive, and multistep process. Learn about a platform and host cell line that minimize the risk and timeline to develop high-performing clones.

FDA Adopts ICH Final Guidance On Bioanalytical Method Validation

The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.

Taking Charge Of Your Stability Program

Conducting stability studies is a critical aspect of the drug development process. Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.

Optimizing Lipid Formulations For Targeted RNA-LNP Applications

Learn about the considerations and challenges of using ionizable lipids, including the 5 types of lipids used for RNA delivery.

Process Development Considerations For RNA-LNP Therapeutics

Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).

Key Stages In mRNA-Based Therapeutic Development

Learn how planning a product development strategy early on with a technology partner who has deep expertise and technical knowledge of genomic medicines can address uncertainties from the outset.

Natural Killer Cells Manufacturing

Follow the feasibility of xeno‑free NK cell expansion, closure of key unit operations, and how future work could focus on fine‑tuning each step to generate a robust, scalable process.

Outstanding Sensitivity For Confident SPR Interaction Analysis

Explore how surface plasmon resonance (SPR)-based analyses with a high sensitivity instrument can provide greater data precision and better confidence in your results interpretation.

Explore Protein Interactions Beyond Affinity To Boost Your Academic Research

Explore how you can simplify research on protein-protein interactions using our SPR systems.