Issue: Vol. 42

Flexibility and education keys to overcoming biosimilar barriers

14 May 2024 No Comments

Since the first biosimilar approval nearly 20 years ago, these lifesaving products have steadily gained an important foothold in U.S. and European markets. These near copies of approved biologic products hold the potential to increase patient access, promising treatments for cancer, autoimmune or inflammatory conditions.

 

While early biosimilars had limited adoption and financial savings, biosimilars launched in recent years have achieved significant uptake and savings thanks to their increased acceptance by healthcare stakeholders and new market opportunities. Yet, while analysts predict that the market could triple in value (1), barriers remain, particularly related to testing requirements.

 

A panel of industry experts share their insights on where the biosimilar industry is headed and how health authorities can support and influence efficient biosimilar development methods. With more biologics set to lose exclusivity, more competition from biosimilars could lead to a greater number of life-changing treatments at a lower cost, benefiting patients and healthcare systems. To achieve this, the panelists agree that what is needed is more industry-regulator collaboration, particularly with regards to updating and aligning the guidance to create more efficiencies.

 

The article explores:

  • Regulatory pathways and how these might impact biosimilar progress
  • The use of comparative analytics in the development of biosimilars, including PK/PD studies to analyze variability
  • The importance of educating stakeholders on the science behind biosimilars
  • Advances in PD markers in demonstrating biosimilarity and ongoing research into new, more sensitive PD markers
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How to mitigate nitrosamine risk with low nitrite excipients

14 May 2024 No Comments

Choosing the right nitrosamine risk mitigation strategy in a constantly evolving market – fuelled by emerging science and innovative technologies – can be challenging, especially when a development pipeline faces multiple routes of possible nitrosamine contamination. One such pathway occurs when an active pharmaceutical ingredient (API) containing a vulnerable amine reacts with nitrite under certain conditions, leading to the formation of API-based nitrosamines (1). Choosing low nitrite excipients is one tool that may reduce the risk of nitrosamine formation, especially when a vulnerable amine is present in the formulated drug product (2-5). Such an approach carries minimal risks and should form part of a holistic strategy to reduce the risk of nitrosamine formation. But why? Read on to uncover the role of low nitrite excipients in nitrosamine control and key considerations that drug manufacturers can bear in mind when planning their nitrosamine mitigation strategies.

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Preparative chromatography of peptides and other large molecules

14 May 2024 No Comments

Over the last number of years, analytical technologies for assessing the purity of a synthetic peptide have changed significantly, with U(H)PLC methods utilising media with specific properties designed to separate peptide impurities used in almost all peptide analyses. Furthermore, additional scrutiny of these methods via mass spectrometry or ion mobility spectrometry ensures that all impurities produced during the manufacture of a peptide are now routinely detected.

The use of preparative chromatography is still the main option for purification of peptides, a technology that has not quite advanced at the same rate, with 10µm C18 silica still the method of choice for most purifications. This paper will describe the holistic approach taken at Almac to ensure peptides and other large molecules produced for clinical and commercial purposes are still able to meet the stringent regulations and increased scrutiny.

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A process digital twin framework for biopharmaceutical manufacturing

13 May 2024 No Comments

To enable robustness, facilitate in silico process characterization, and enable an efficient process control strategy, we are developing a digital twin framework using data-driven and mechanistic modeling approaches. The Digital Twin will be transformational in bringing significant value across process lifecycle from real time prediction to cyber-resiliency.
In this paper, we present a visionary perspective on the potential of digital twin technology to assist in biopharmaceutical manufacturing. Our focus is on outlining the strategic framework for a digital twin platform and discussing the conceptual development of a digital shadow for an integrated continuous process. Such digital shadow can be used to determine the impact of expected disturbances, deviations, and uncertainties on product quality. The vision is to use residence time distribution analysis to identify the duration of product diversion in response to the deviation, and allow product impacted by disturbance to be diverted without impacting the reminder of the batch.

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PAT – Advancing innovation, efficiency and control in biopharma manufacturing

13 May 2024 No Comments

Process Analytical Technology (PAT) offers significant opportunities to improve process understanding and optimize product quality in biopharmaceutical manufacturing. Aim of the article is to provide an overview on PAT with a special focus on bioprocesses and highlight how Raman spectroscopy, in particular, is well-suited for applications in the biopharma sector due to its non-destructive nature, high molecular specificity, and ability to analyze multiple analytes simultaneously. These capabilities enable real-time monitoring of complex bioprocess solutions, facilitating optimization of product attributes and supporting process efficiency throughout the biopharmaceutical manufacturing workflow. Overall, PAT, with its emphasis on Raman spectroscopy, enhances process understanding and helps ensure consistent and high-quality biopharmaceutical production while also optimizing processes and saving time and resources.

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A patent landscape of ammonia industrial synthesis

13 May 2024 No Comments

This paper presents a method for extracting and analyzing patent data specific to the industrial synthesis of ammonia.
The research was performed using Espacenet and Orbit Intelligence applying a combination of keywords and classification symbols.
The main classification codes used are as follows C01C 1/02 (Preparation of ammonia), C01C 1/04 (Preparation of ammonia by gas phase synthesis), C01C 1/0405 (Preparation of ammonia by gas phase synthesis from nitrogen and hydrogen in the presence of a catalyst), and C25B 1/27 (Electrolytic production of ammonia).
Thermocatalytic methods, specifically the Haber-Bosch process, are the most frequently claimed.

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Containment Performance Assessment of a DPTE® Alpha Port

13 May 2024 No Comments

To assess the containment performance of the DPTE® Alpha port, a suitable and easily repeatable task was required to challenge the device. This was achieved by subjecting an active pharmaceutical ingredient (API) isolator chamber (which housed the DPTE® Alpha port on the right wall) to an internal airborne concentration of a surrogate powder (acetaminophen). A commonly performed task within the pharmaceutical industry was chosen to accomplish this, specifically transferring a small quantity (500 g) of the surrogate powder, from one container to another. The containment performance of DPTE® Alpha ports has been reliably assessed and the data indicates their suitability as contained transfer devices when handling potent and highly potent pharmaceuticals.

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