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Overcoming regulatory issues with investigational medicinal product labelling 

Pharmaceutical Technology

Issues with regulatory requirements and documentation can also cause significant delays, while any inaccuracies in translations on labelling can mean that dosage and storage information is not correctly understood or followed. Upcoming biotechs need to get moving and they don’t have time to wait for a packaging slot for eight months.

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Mitigating the risks of cross-contamination during Oral Solid Dose (OSD) manufacturing

Pharmaceutical Technology

Compared to other dosage forms, tablets are simpler to manufacture, package, and transport. Download the whitepaper below to find out more about ILC Dover’s flexible solutions for protecting the entire supply chain. Please check your email to download the Webinar.

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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. To find out more, download the whitepaper below. Free Whitepaper.

Dosage 52
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Accurate dosing: How to achieve maximum precision with poor-flowing products

Pharmaceutical Technology

Due to rising healthcare spending, launch of novel treatments, and the rise of chronic diseases in an aging population, the global pharmaceutical packaging equipment market is rapidly expanding. There are also outside variables that can affect the flow of powders, requiring specific dosage methods to achieve the desired result.

Dosage 52
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Modernizing cell culture processes for the next wave of genomic medicine

Pharmaceutical Technology

She estimates that — with the gene therapy industry switching focus from treating only orphan diseases to more prevalent indications and conditions requiring more viral vector particles per dosage — yearly viral vector demand “could easily increase by one million-fold”. Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus.

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The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). www.fda.gov/media/162157/download 7 Okwudire, C. Discussion paper. October 2022.