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

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.

2022 Outsourcing Trends In Biopharmaceutical Manufacturing

The continued focus on productivity and efficiency is moving manufacturers to increasingly consider outsourcing activities. Biomanufacturers are spending more, demanding better technologies, and expressing greater optimism. This article shares the trends in outsourced activities, percentages of activities outsourced, outsourcing destinations, and offshoring.

De-Risking Biosimilar Development With A Clinically Validated And Commercially Proven Disposable Autoinjector

Discover how a biopharmaceutical company can de-risk the launch process by choosing a suitable autoinjector technology and partner.

New ICH Q14 Guidance Applies QbD To Analytical Procedures

ICH's new draft guidance (Q14) for Analytical Procedure Development describes an enhanced approach for method development, validation, and life cycle management employing elements of quality by design (QbD) and risk management tools. This article also explains the differences between this enhanced approach and the traditional approach.

Biosimilar Interchangeability: Regulatory & Practical Considerations

Biosimilar interchangeability refers to the possibility of exchanging the reference biological product with its biosimilar (or vice versa) or exchanging biosimilars of the same reference product. This article provides an up-to-date overview of regulatory and practical considerations regarding biosimilar interchangeability with an emphasis on the European perspective.

ICH And USP <1220>: Implementing A Quality By Design Analytical Framework

The International Council for Harmonization (ICH) and the United States Pharmacopoeia (USP) are finalizing draft guidelines that describe a new paradigm for analytical development based on the quality by design (QbD) approach used for pharmaceutical development. The new chapter will become official on May 1, 2022.

Imaging Large Volume Subcutaneous Injections In Swine and Human Models Informs Effective Clinical Design

New higher volume, higher viscosity pharmaceutical formulations for subcutaneous injection, alternatives to traditional intravenous treatment, enable chronic disease therapy in alternate settings.

Training Devices And Patient Education Play A Crucial Role In The Self-Injection Drug Delivery Market

Understand the role training devices and patient education play with regard to self-injection therapies. Review the evolution of injection devices and prefilled syringes, the benefits of training devices combined with patient education, and an empirical look at patient training.

Capture Of Histidine-Tagged Molecules Using Biacore His Capture Kit

Find recommendations for immobilization of histidine-tagged molecules (ligands) by capture to an anti-histidine antibody covalently coupled to a sensor chip surface.

3 Tips For Purifying His-Tagged Proteins

Tags simplify purification and enable scientists to use standard protocols while also improving the yield, purity, and solubility of the protein of interest.

Combining Ambr 15 Cell Culture With Octet Titer Measurements

This platform is an analytical instrument that can easily be implemented in cell line development labs to facilitate rapid determination of product yield.

Increase Drug Discovery Productivity, Optimize SPR Data Interpretation

The need to increase efficiency and productivity has led scientists to develop a machine learning solution that can optimize the way that developers analyze and characterize their early drug candidates.

3 Successful Strategies For Protecting Your New Biopharma’s IP

Intellectual property is the lifeblood of new biopharma entities. Patent protection is necessary to secure investment, to build a solid foundation with opportunity for future growth, and to establish viability within a highly competitive landscape. This article addresses key patent-related considerations for startups and small or early-stage players in the life sciences arena.

B. Cepacia: A Case Study For Determining Objectionableness In Drug Manufacturing

After introducing the subject of colonization and opportunistic pathogenicity in part 1 of this 2-part series, the authors return to discussing B. cepacia in more depth in this article.