PharmaShots

NOVEMBER 25, 2022

Shots: The collaboration combines XtalPi's AI algorithm, molecular modeling & automated experiments to develop an AI tumor vaccine R&D platform & design capabilities of tumor vaccines to activate specific immune responses to kill tumors, accelerate the R&D process, improve the success rate & efficacy of tumor vaccines The platform (..)

Vaccines 40

Vaccines Immunization Compounding Process Improvement 40

Omnicell

JANUARY 10, 2023

It has developed a framework that identifies five levels of increasing technological capability and work process improvement spanning nine pharmacy work processes. The Advisory Board has coalesced around the clear vision of a fully autonomous pharmacy.

Medical Schools 52

Medical Schools Process Improvement 52

The FDA Law Blog

NOVEMBER 1, 2022

The bar for demonstrating comparability is high if a manufacturing change is introduced in the middle of a Phase 2 pivotal study versus if a sponsor introduces a process improvement between Phase 1 and before starting the Phase 2 pivotal study. Release testing alone is not sufficient.

FDA 59

FDA Process Improvement 59

European Pharmaceutical Review

AUGUST 29, 2022

They need to resolve any issues that affect cell performance and quality, whether it is media optimisation or process improvement. They also want to produce larger quantities of viable media in a timely manner.

Process Improvement 87

Process Improvement 87

Fuld

JANUARY 21, 2020

We often deploy our Intelligence Benchmarking Survey as a barometer for process improvement opportunities with many of our clients and over the years have found that nearly 60 percent of the organizations we’ve surveyed struggle with demonstrating and managing the perceived value of competitive and market intelligence initiatives.

Process Improvement 78

Process Improvement Documentation 78

Pharmaceutical Technology

MAY 9, 2023

For Jamaels, whose track record in managing complex operations and delivering process improvements spans GSK Vaccines and one of the world’s largest companies, GE, the technological shift is an exciting development: “I’m passionate about the digital transformation that our industry is going through,” he says.

Vaccines 52

Vaccines Process Improvement Communication 52

ISPE

OCTOBER 27, 2022

Combining the incremental process improvements previously mentioned results in an optimized facility, with the adjusted block flow shown in Figure 5. The synthesis unit operation routinely takes 8 to 12 hours start to finish, but it can take 3 to 5 days between batch starts using a single synthesis column.

Dosage 98

Dosage FDA Compounding Process Improvement 98

ISPE

MARCH 29, 2023

2 Regulatory Binding Elements/ECs In the proposed comprehensive QOS, a summary of pharmaceutical development information along with a table that conveys the control strategy is provided.

Dosage 52

Dosage Documentation FDA Packaging 52

ISPE

MARCH 29, 2023

2 Regulatory Binding Elements/ECs In the proposed comprehensive QOS, a summary of pharmaceutical development information along with a table that conveys the control strategy is provided.

Dosage 52

Dosage Documentation FDA Packaging 52

ISPE

MARCH 15, 2023

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). 7 An integrative (vs.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52

ISPE

AUGUST 29, 2022

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations.

FDA 52

FDA Documentation Method Validation Packaging 52

ISPE

AUGUST 30, 2022

In the long term, a collaboration between regulators and industry stakeholders to develop and implement harmonized guidelines for raw materials would help address flexibility challenges, prevent delays in implementing process improvements, and ensure that both regulator and industry resources are devoted to the most critical issues.

FDA 52

FDA Documentation Packaging Dosage 52