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How to remain a top CDMO in ADC-led oncology

Pharmaceutical Technology

In 2011, the market was worth an estimated $50m. How will RFK Jr’s American dream for vaccines play out? Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest E. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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CMC Requirements for New Drug Registration in Latin America

ISPE

In addition to the COR, some Latin American markets require approval in the COO, which is defined as the country where the drug is manufactured, packaged, or exported from. Sometimes, COAs for the drug substance, the excipients used in the formulation, and the primary and nonfunctional secondary packaging material are requested.

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Sustainability: Corporate Ambition, Governance, & Accelerated Delivery

ISPE

Representatives from R&D, manufacturing and supply, and commercial should all be included at the top-level forum, along with the main functions needed for delivery such as the sustainability group, engineering, procurement, legal, and corporate communications. Communicating keynote successes will help encourage engagement and support.

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Challenges for Net Zero Carbon Pharmaceutical Manufacturing

ISPE

Published September 2011. solvent selection, inhaler propellant replacement, and packaging design) to employee travel and commute policy (e.g., recycled content in packaging, reduction of packaging weights). You may unsubscribe from these ISPE communications at any time. Greenhouse Gas Protocol website.

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Supporting Cell & Gene Therapy through Multimodal & Flexible Facilities

ISPE

DPS project experience, December 2011–August 2022. Different engineering disciplines, such as architectural and process piping, may use different software packages, which can then be combined into a single coordinated model. You may unsubscribe from these ISPE communications at any time. 4 Stanton, D. BioProcess Insider website.

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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). Nature Communications 12, no. Biotechnology Progress 36, no. 3 (2020):e2970.

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Contamination Trends & Proposed Solutions

ISPE

The cases covered the same types of contaminants and impurities noted in Table 1: microbial contaminants, process-related im-purities, metal contaminants, packaging-related contaminants, drug cross-contamination, and an “unknown” category encompassing other contaminants associated with the manufacturing process, including those from cell culturing.