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.

Effect Of Benzonase® Endonuclease Addition To Purification Of Sabin Polio Virus Type 3

In vaccine and viral vector production, impurity clearance is an essential purification step and required for drug approval as residual impurities may impact patient safety. A critical step in the purification process is reduction in the size and quantity of extracellular nucleic acids by endonuclease enzymes. This application note summarizes the benefits of incorporating Benzonase® endonuclease in a polio virus type 3 production process.

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.

Objectionableness: How To Know If A Microorganism Poses A Risk In Your Drug Product

It is important to consider at the beginning of an exploration of species “objectionableness” in microbiological analysis that this idea is unique to our specific corner of the world. If you search for a definition of objectionable organisms in a microbiology reference text, you are unlikely to find one. This article, as part 1 in a 2-part series, meets that need.

Why Should We Rescue The Legislative Intent Of The BPCIA?

What happens when regulatory ambiguity displaces sound scientific guidance, deterring the legislative intent of Congress? This is precisely the situation regarding the FDA changing the regulatory rules of the road regarding a biosimilar’s strength versus its potency.

Patent Transparency For Biologics & Biosimilars: The Revamped Purple Book

The FDA recently updated the “Purple Book” — a database containing information about all licensed biological products — to include, for the first time, patent information relating to biologics as well as FDA regulatory exclusivity information.

New US Legislation Creates Momentum For Biosimilars

Most biosimilars (follow-on biologic products) still only have shares below 50% in the U.S., which is far different than market shares in Europe. One major reason is a mistrust around biosimilars’ safety and efficacy. Congress has stepped in to address that issue through the Advancing Education on Biosimilars Act of 2021, with the goal of encouraging rapid uptake soon after biosimilars become commercially available.

Peptides: Best Practices On Regulatory & Control Strategies, Analytical Methods, & More

Industry, regulatory, and academic experts recently gathered at the United States Pharmacopeial Convention’s (USP’s) annual Peptides & Oligonucleotides Workshop virtually to share best practices on chemistry, manufacturing, and controls (CMC) for peptides. This article summarizes discussion highlights.

Outlook: Biotech In 2021 & Beyond

Biopharma companies have responded in an astounding manner to the COVID-19 pandemic through vaccines, therapies, diagnostics, and variant tracking. For those efforts, the industry is seeing some amazing investor awareness, political support, and increased public perception. This article focuses on the U.S., but also includes some worldwide numbers.

No, Biologics Are Not Natural Monopolies

Biologics are not natural monopolies, as certain individuals continually assert. This assertion threatens future innovations, greater healthcare affordability, and patient access. This article, backed up with data, debunks the myth that biologics are natural monopolies.