Remove topic biologic-apis
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Evaluating NMR relaxometry for antibody identification

European Pharmaceutical Review

The measured relaxation rate constants resulting from fast chemical exchange between water and exposed NH and OH protons on proteins can be selective to biologics. This has led to applications with biopharmaceutical formulations and protein investigations. This has significant cost savings. IPQ International Pharmaceutical Quality.

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2022 ISPE Annual Meeting: Convergence and Harmonization Support New Therapies

ISPE

Director, Center for Biologics Evaluation and Research. The regulatory keynote was delivered by Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research (CBER), US FDA. Director, Center for Biologics Evaluation and Research. Lonza Biologics. Peter Marks, MD, PhD. Peter Marks, MD, PhD. David Churchward.

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Exclusive Coverage: Global PHT Expo & Summit 2023

PharmaShots

The theme of the event was Innovation, Advanced Technology, Current Challenges & Opportunities in Pharma & Healthcare Industry under which a series of presentation sessions and panel discussions were held related to pharma trends, APIs, policy reforms, AI, metaverse, current regulatory trends and the direction of pharma and drug discovery.

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CPHI Barcelona 2023 – Event preview

European Pharmaceutical Review

API Development & Innovation 3. At the Heart of Pharma Conference agenda highlights CPHI Barcelona 2023 will feature an extensive conference agenda covering a wide range of topics, including next-gen biomanufacturing, partnering for success, formulating the future, future therapies, manufacturing 4.0, Accelerating Innovation 2.

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Why QbD and Digitalization Are Foundations for Cell Therapies

ISPE

The base biological and mechanical functions are in place to allow for automation. This is very different to working with small molecule APIs and ingredients, and so we need to wait for a while until cell therapy becomes popular and there is more impetus to change our thinking on topics such as validation and compliance.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

For a biologic drug, the DS is manufactured upstream in cell culture media followed by downstream purification, which requires chemicals, filters, and resins. For example, biologically sourced raw materials may require careful evaluation to establish the presence or absence of deleterious endogenous or adventitious agents. authorities.

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Sustainability: Corporate Ambition, Governance, & Accelerated Delivery

ISPE

5 , 6 , 7 Failure to properly address the topic of environmental sustainability not only impedes wider efforts to address climate change, but also could have a material impact on the company’s business. These expectations are defined in various national codes. 3 Science Based Targets Initiative. Nature-Based Solutions Initiative. Atkins, P.