PharmaShots

FEBRUARY 20, 2023

Technologies and innovations have transformed the world globally. Traveling to different places, interacting with new people, working remotely from home, and much more comes with evolving technologies. After the outbreak of any epidemic or pandemic, all the responsibilities come on the shoulders of pharmaceutical companies.

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ISPE

JULY 7, 2023

USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics Trudy Patterson Fri, 07/07/2023 - 08:45 Features July / August 2023 USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics John F. This article summarizes trends from the workshop and ponders next steps.

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PharmaShots

MARCH 14, 2023

Shots: With the healthcare sector moving ahead with its technological advances, there is still an unexplored section in therapeutics that requires much more attention. The article focuses on challenges faced in drug development, government incentive programs, grants, and various therapies used to diagnose or treat rare diseases.

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European Pharmaceutical Review

DECEMBER 22, 2022

Innovations in antibody design have led to an increasingly diverse range of therapeutic molecules in development including bispecific antibodies (bsAbs). Innovative bsAb designs, as highly targeted medicines, hold the promise of changing the way we treat cancer and other diseases. Rapid development of clonal cell lines.

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ISPE

JULY 6, 2023

This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data- and knowledge-centric approach to risk management can help CM achieve its full potential. It is recognized as a key process intensification approach.

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ISPE

MARCH 6, 2023

Challenges for Net Zero Carbon Pharmaceutical Manufacturing Trudy Patterson Mon, 03/06/2023 - 12:40 Features March / April 2023 Challenges for Net Zero Carbon Pharmaceutical Manufacturing Keith M. 1 Intergovernmental Panel on Climate Change (IPCC). Finalized 9 August 2021. C global warming scenario.

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ISPE

AUGUST 29, 2022

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Regulatory submission and evaluation of chemistry, manufacturing, and controls (CMC) data may be required for changes that have a higher risk to impact product quality.

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ISPE

MARCH 15, 2023

Environmental Sustainability in Biopharmaceutical Facility Design Trudy Patterson Wed, 03/15/2023 - 09:13 Online Exclusives March / April 2023 Environmental Sustainability in Biopharmaceutical Facility Design William G. Table 1: Facility environmental sustainability tools and example values. 7 An integrative (vs.

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ISPE

OCTOBER 27, 2022

Cell and gene therapies (C>) have unique needs in manufacturing suites that differ from those for classic product biopharmaceuticals. C sponsors currently address numerous emerging pharmaceutical entities, as well as manufacturing platforms, modes, and scale. These considerations include processing safety (e.g.,

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