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Developing & Manufacturing Drugs with HPAPIs

PharmaTech

Developing and manufacturing complex novel oral solid dose products of highly potent compounds requires specialized expertise. The degree of potency and specific risks will determine the level of containment needed to ensure operator safety and prevent cross contamination at the development and manufacturing facility.

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Leading speciality pharmacies in pharma

Pharmaceutical Technology

Speciality pharmacies play a crucial role in medication dosing, disease and side effects management, and patient care. Speciality pharmacies provide comprehensive medications for individuals with serious medical conditions requiring complex treatments, including cancer, cystic fibrosis, haemophilia, hepatitis, HIV, and others.

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Medicinal cannabis: the route to good manufacturing practice registration

European Pharmaceutical Review

Crucially, January 2023 marked a key moment: the Medicines and Healthcare products Regulatory Agency (MHRA) granted Celadon Pharmaceuticals the first good manufacturing practice (GMP) registration since legalisation in 2018 for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API).

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FDA completes inspection of Nexus’ manufacturing facility in US

Pharma Leaders

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility.

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Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Pharmaceutical Technology

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

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Handling HPAPIs safely – what does it take?

European Pharmaceutical Review

In this Q&A, Dr Hotha offered expertise on the requirements and challenges of handling HPAPIs during manufacture. There are emerging trends in oncology, with new chemical entities (NCEs) and antibody-drug conjugates (ADC) leading to increased demand for HPAPI manufacturing capabilities.

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