Wednesday, May 17, 2023 Daily Archives

Viral Safety for Biotechnology Products, Including Viral Vectors: ICH Q5A Revision 2 Brings Updated and More Comprehensive Guidance

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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidance on the testing and evaluation of viral safety of biotechnological products derived from characterized cell lines of human or animal origin through its harmonized guideline ICH Q5A (1). The latest revision, released for consultation in October 2022, maintains the key principles of previous versions while introducing key changes in response to important advances in the field. Those advances are covered in new sections that…

May 17, 2023
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Process Validation: Calculating the Necessary Number of Process Performance Qualification Runs

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The 2011 process validation (PV) guidance document from the US Food and Drug Administration (FDA) states that the number of samples used for PV “should be adequate to provide sufficient statistical confidence of quality both within a batch and between batches. The confidence level selected can be based on risk analysis as it relates to the particular attribute under examination” (1). In alignment with those expectations, I present herein two statistical methodologies for calculating the necessary number of process performance…

May 17, 2023

Building the Next Generation of Cell-Line–Development Platforms

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Speed to market is a critical business driver in the biopharmaceutical industry. However, drug development success also requires building a robust process that maximizes efficiency while limiting the cost of goods. Achieving time and cost savings without compromising product quality is critical. Development of a productive and stable cell line is the foundation of an efficient and high-performing bioprocess. Cell-line development (CLD) represents some of the most resource-intensive steps within a process development pipeline. Bioprocess scientists must find a balance…

May 17, 2023

Advantages of Mixed-Mode Chromatography in Host-Cell Protein Removal

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Monoclonal antibodies (MAbs) are the fastest-growing modality in clinical trials and more than 100 such therapies have been approved to treat diseases. But despite the modality’s success, MAb manufacturing is often contaminated by host-cell protein (HCP) by-products. Tom Valorose, senior product manager at Astrea Bioseparations, discussed how companies can reduce HCPs dramatically during MAb purification. Valorose’s Presentation Removing HCPs is an important part of MAb downstream processing. After cell harvest, scientists perform a primary capture using affinity chromatography with protein…

May 17, 2023

Streamlining and Accelerating Biosimilar Adoption in the United States

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Biologic medicines have brought extraordinary clinical benefits to patients living with difficult conditions such as cancer and autoimmune and ophthalmic diseases. But such therapies are expensive, accounting for about 43% of pharmaceutical spending in the United States (1). The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created a regulatory pathway for a class of biologics called biosimilars, which replicate branded biologic drugs at lower cost (2, 3). The BPCIA was designed to provide greater access to biologics by…

May 17, 2023

Seven Steps to Build a Productive CDMO/Sponsor Relationship

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Once the hard work of selecting a capable biologics CDMO partner is complete, what does it take to build a productive CDMO/sponsor relationship? When evaluating biologics CDMOs, technical capabilities are understandably the primary selection criteria. Once critical technical fit and capacity are known, cultural compatibility becomes an essential ingredient in making the working relationship fruitful. At Bionova Scientific, we’ve built a reputation as a scientifically strong CDMO with the latest tools and infrastructure. But since our early days, we have…

May 17, 2023

Astellas and Sony ink deal to develop ADC platform

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Using Sony Corporation’s KIRAVIA Backbone material, Astellas Pharma has partnered with the firm to jointly discover an antibody-drug conjugate (ADC) platform. The collaborative research agreement, of which financial details have not been disclosed, will focus on developing an ADC platform in oncology using Sony’s polymeric material, KIRAVIA Backbone, as a linker. The linker  delivers anti-cancer drugs to targeted cells and aims to improve therapeutic efficacy by reaching high Drug-to-Antibody Ratio (DAR). According to both parties, the linkers conjugates antibodies and…

May 17, 2023

Bavarian Nordic: Boosting inhouse manufacturing drives vaccine ambition

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The takeover of a Swiss plant from contract manufacturer Emergent will bring Bavarian Nordic greater control of its vaccine production, the firm says. In February, Danish drugmaker Bavarian Nordic inked a $270 million agreement to buy numerous vaccine assets and a manufacturing facility in Bern, Switzerland from contract development and manufacturing organization (CDMO) Emergent Biosolutions. Yesterday, the deal closed. Speaking on the firm’s Q1 results, CEO Paul Chaplin said the acquisition is key in helping Bavarian Nordic become “one of…

May 17, 2023

Lilly working to resolve mirikizumab manufacturing issues following CRL

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Eli Lilly expects mirikizumab to become the first interleukin-23 subunit alpha (IL-23p19) to treat ulcerative colitis once manufacturing issues highlighted by the US FDA are resolved. Last month, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to Eli Lilly for mirikizumab, its monoclonal antibody candidate for the treatment of ulcerative colitis (UC). Patrik Jonsson, president of Lilly Immunology, discussed his company’s approach to resolving the issue at the Bank of America Securities 2023 Healthcare Conference…

May 17, 2023