Pharmaceutical Technology

FEBRUARY 23, 2023

Our chemists and formulation scientists review the properties of new drug candidates and “work their magic” to develop formulations that improve the exposure profile of the compound. How does bioavailability play a role in biopharmaceutics? Now fraction absorbed and bioavailability are often confused and used interchangeably.

Compounding 98

Compounding Dosage Packaging Communication 98

Pharmaceutical Technology

MARCH 20, 2023

These are mainly all those with a compound in BioNTech’s pipeline. The US Food and Drug Administration (FDA) granted Fast Track designation to ONC-392 as a monotherapy to treat immunotherapy-resistant non-small cell lung cancer (NSCLC). BioNTech will solely develop all the combinations other than the PD-1 inhibition.

Compounding 98

Compounding Communication FDA 98

ISPE

MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

Documentation 52

Documentation Dosage Packaging Communication 52

Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. The demand for injectable drugs is rising. This was higher than the number of approvals in 2019 and 2020.

Packaging 52

Packaging Compounding Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

SEPTEMBER 11, 2023

Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” September 2022. 7 March 2023. Regulatory Focus.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52