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Using analytics and bioassays to de-risk your mRNA LNP drug development programme

Pharmaceutical Technology

But the mRNA technology is not yet mature and there are no standardised manufacturing protocols yet. Companies that want to develop drugs using these new modalities must not only find new sources of material to bring to a CDMO but they should also understand the many variables that could cause the project to fail. “If

Bioassay 130
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Topical products: Aiming for quality, simplicity, and cost-efficiency in their development, scale-up, and manufacturing

Pharmaceutical Technology

The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. Optimising development and scale-up.

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Toregem BioPharma and WuXi Biologics to partner for antibody development

Pharmaceutical Technology

As part of the collaboration, Toregem will use WuXi Biologics’ integrated CMC services in cell culture development, cell line development, bioassay development, biologics GMP manufacturing, cell banking and testing services, as well as other related services. TRG035’s Phase I clinical study is scheduled to begin in early 2024.

Antibody 130
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Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

Dr Megan MacBride and Dr Caroline Horizny Mitchell , Taconic, examine recent changes to animal testing in drug design. Drug discovery and development is an arduous process that can cost upwards of $2.6 In August 2022, the ICH issued an addendum to its S1B guidelines that allows certain drugs to forego two-year rat studies 1.

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Addressing the challenge of salt forms in drug discovery

Drug Discovery World

These can have better properties than their parents, including preferable stability, solubility, bioavailability, and manufacturability. millimolar solution for a bioassay or a milligram amount of a reactant for a synthesizer could have detrimental skewing effects on a derived dose response curve or could lead to an unbalanced reaction.

Drugs 52
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Reflecting on PEGS Europe 2023 

Drug Discovery World

Protein process development In the protein purification session, Anis Larbi, Senior Manager Medical & Scientific Affairs, Beckman Coulter Life Sciences, presented on reducing the complexity of protein manufacturing and streamlining the workflow.

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What to expect from PEGS Europe 2023: Day 2

Drug Discovery World

The first three include: Sungjin Park, PhD, CEO, Onegene Biotechnology, on: ‘UniStac: Enzyme-mediated conjugation technology for accelerated development of tetraspecific NASH drug’. Ioanna Stamati, PhD, Team Leader, Bioconjugation, Antikor Biopharma, on: ‘Antibody fragment drug-conjugates (FDCs): Analysing novel formats with high DAR’.