Formulation Development Featured Articles
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The Digital Future Of CMC Regulatory Affairs
6/23/2023
This article discusses recent initiatives from the FDA, such as KASA, PQ/CMC, and the ICH SPQS. Let's look at how they could be the early birds of the paradigm shift from electronic CTDs to digital CTDs. The article also addresses what steps the industry should be taking in parallel with the authorities in preparation for this (very near) digital future.
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Lost CMC Data In An ALCOA+ World
6/19/2023
As technologies advance, the drug/therapy products we make are becoming more complex, and so are their data fingerprints. This article takes a hard look at the way we currently capture and manage chemistry, manufacturing, and controls (CMC) development and manufacturing operations data, and sheds light on how the document-centric mindset of ALCOA+ is not suitable to support the transition to digital CMC and FAIR data management.
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The Growing Use Of Antibody Library Technologies In Drug Discovery
6/14/2023
Antibody library technologies enable the screening and identification of antibodies with desired properties (such as high affinity and specificity) for a wide range of targets, including proteins, peptides, small molecules, and even complex cellular structures. Here are the key emerging trends.
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FDA Seeks Input On AI Adoption In Drug Development And Manufacture
6/13/2023
The FDA released two discussion papers for consideration: Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products and Artificial Intelligence in Drug Manufacturing. The papers identify current and potential areas for AI adoption.
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Optimizing Digitalization To Accelerate Your R&D
5/19/2023
Drug/therapy development has made significant leaps in innovation in recent years, but common issues that hinder progress still exist. Are you harnessing and optimizing your data for speedier drug development and quicker launch timescales? This article shares important recommendations.
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Leveraging AI In Drug Discovery To Treat MS & Other Autoimmune Diseases
5/17/2023
The advancement of artificial intelligence and machine learning algorithms means we can use large pools of genetic data to identify potential risk factors and disease-causing genes for multiple sclerosis and other autoimmune diseases. This author shares a three-pronged approach to analyzing data for AI algorithms, pitfalls to avoid, and AI for silico modeling.
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A Primer On ICH M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
5/16/2023
The International Council for Harmonisation (ICH)'s reflection paper on "Further Opportunities for Harmonisation of Standards for Generic Drugs," released back in 2018, is currently in public consultation stage and slated for adoption in November 2023. It provides recommendations on conducting bioequivalence studies during development and post-approval phases for immediate release solid oral dosage forms.
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Key Considerations For Developing Next-Generation Antibody-Drug Conjugates
5/11/2023
Fourteen antibody-drug conjugates (ADCs) have been approved globally for cancer indications so far. This article shares considerations for complementing target with antibody subtype, optimizing format for half-life functionality, and delivering payloads with diverse MOA.
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Addressing 3 Challenges Of Developing Or Using A New Excipient
5/8/2023
As the world discovers new molecular entities, new solutions for and innovation of excipients are more critical than ever. However, they are often overlooked. Let’s look at how to address three key challenges: risk aversion, an inconsistent feedback loop between pharma companies and excipient suppliers, and the current lack of regulatory body-backed innovation programs.
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An Inside Look At CMC Strategy Development For Novel Biologic Formats
4/28/2023
Understand an integrated drug substance and drug product CMC strategy for novel molecular formats and other recombinant proteins and tailored, product-specific solutions that enable acceleration into the clinic.