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Outsourcing Biologics Fill Finish Manufacturing : Streamlining the Production Process for Biopharmaceutical Companies

Roots Analysis

Further, the manufacturing of biologics fill finish is a highly complex and cost-intensive process. For instance, small biotech companies enter into agreements with fill finish manufacturing companies due to lack of in-house capacity.

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How API CMOs can improve containment capabilities without facility acquisition

Pharmaceutical Technology

According to GlobalData analysis, specialist small molecule API capabilities such as containment or controlled substances are driving large contract manufacturing organisations (CMOs) to acquire facilities. Download the whitepaper below to find out more about ILC Dover’s flexible solutions for protecting the entire supply chain.

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Indian pharma manufacturing: rising investment in Andhra Pradesh

Pharmaceutical Technology

Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. Pharma manufacturing facilities in Andhra Pradesh and Telangana accounted for 22.5% © GlobalData. ©GlobalData.

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API landscape in 2022: Drivers and solutions for small molecules

Pharmaceutical Technology

Research by GlobalData (Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition) shows that containment facilities are in high demand as the use of cytotoxic drugs continues to grow. This adds to costs and places higher demands on PPE due to risks of exposure: “Production is more costly.

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CMO Moves: Regulatory catalysts for drug manufacturing-April

Pharmaceutical Technology

Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. In this ongoing series , we put a spotlight on contracts between pharma companies and contract manufacturing organizations (CMOs). Covid-19 vaccines stay in the spotlight.

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HPAPIs – Current Interest of the Pharmaceutical Industry

Roots Analysis

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

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FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

FDA Law Blog

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.