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ICH's new draft guidance (Q14) for Analytical Procedure Development describes an enhanced approach for method development, validation, and life cycle management employing elements of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.

Effectively Educating Clinicians And Patients On Biosimilars Across Europe: Getting The Right Message Across

Biosimilars are here to stay, so it is essential that the different stakeholder groups (healthcare providers, patients) receive trustworthy and clear information about the principles and the value proposition.

Assessing CT-P13 SC’s Impact Across Indications

This is the second article in a two-part series exploring the anticipated competitive dynamics for Celltrion’s subcutaneous (SC) infliximab bio-better, CT-P13 SC, in the U.S.The author explores how market dynamics across different autoimmune indications will drive distinct uptake of CT-P13 SC, highlighting the potential impact on TNF inhibitor competition.

Subcutaneous Infliximab In The U.S.: Defining CT-P13 SC’s Competitive Edge

TNF inhibiting biologics still reign supreme when treating immunological diseases. GlobalData believes that Celltrion’s CT-P13 SC will likely see better success than IV infliximab biosimilars in the U.S. In Part 1 of this two-part article series, we assess the factors that may give CT-P13 SC a competitive edge over Remicade and IV infliximab biosimilars.

The Biosimilar Leadership Playbook: 5 Tips For Success

In the next five to 10 years, what will define a leader in the biosimilar space? Which skills will be the most important to long-term growth in the biosimilar space? Here McKinsey & Co.'s Jorge Santos da Silva shares five specific best practices emerging for any company looking to be — or remain — a leader in the biosimilar space. 

The Opportunities & Challenges Of India’s Biologics Market

Biosimilar drugs, due to their affordability, can play an important role and allow the Indian government to have a better healthcare system. However, as issues remain on the regulatory and manufacturing sides, India needs to see strong improvements to compete and appear as an important hub nationally and internationally.

Will It Be Biologics Business As Usual In 2021, Or Will Biosimilars Mean Business?

In this fourth installment of the Editorial Board 2021 Outlook, it's clear that stakeholders are relying more heavily on biosimilars and that it’s more important than ever for biosimilar companies to keep carrying the torch for more competition, cost-savings, value, and responsible pricing.

The Top 5 Biosimilar Developments Of 2020

Though 2020 felt like an endless descent into Dante’s Nine Circles of Hell, I wanted to end the year as I typically do: with a column highlighting the most important and positive biosimilar developments from the past 12 months.

The Second Wave Of Biosimilars: New Scenarios, New Rules

The arrival of what we could call the first “bio patent cliff” has revealed important lessons that should be taken into consideration when selecting new candidates for the second and third waves.

Biosimilar Experts Reflect On 2020’s Greatest Biosimilar Achievements

As the amazing members of the Biosimilar Development Editorial Board emphasize here, there is a lot to be thankful for in the biosimilar world. Check out the first of what will be a four-part series showcasing the editorial board’s thoughts on the past year and the year(s) ahead.

Accelerate Your Pipeline With CDMO Collaboration

Collaborating with a CDMO can augment your capacity and expertise, refine your processes, and ultimately shorten your time to market. This ebook offers best practices that make working with a CDMO as efficient as possible.

3 Expert Perspectives On Biosimilar Differentiation & Biobetter Development

In part two of this two-part series, several experts from a DIA panel share additional insights around the types of differentiation biosimilar companies can pursue and its overall impact on product/device selection and the manufacturing process.