Pharmaceutical Online

Pharmaceutical Online
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Pharmaceutical Online

 •  April 20

When looking at facility commissioning and qualification, it's often good to start out with understanding key words so that everybody's on the same page. When the pharmaceutical industry uses the terms “commissioning” and “qualification,” commissioning could be applied to any facility, while qualification is an aspect of commissioning that refers...

Pharmaceutical Online

 •  April 20

The importance of using ultra clean containers in biopharmaceutical and vaccine applications cannot be overstated. To make informed container choices, understanding regulatory requirements and product claims is essential. Particulates can come from the drug ingredients, containers, tubing and equipment used in production of these products....

Pharmaceutical Online

 •  April 19

Industry Insights Designing A Biomanufacturing Facility Incorporating Single-Use Technologies Article | By Peter Genest and John Joseph, GE Healthcare Life Sciences When building a new facility based on single-use technologies, or incorporating single use into an existing facility, how do companies ensure they fully realize the...

Pharmaceutical Online

 •  April 19

This white paper focuses on how to enhance a pharmaceutical production facility's process safety with a dynamic checkweighing system. It details how checkweighers can help in meeting compliance requirements while enhancing productivity and ensuring products are safe. It also looks at how smart software and mechanical features can play a vital role...

Pharmaceutical Online

 •  April 19

Current techniques used to separate adherent mammalian cells from microcarrier beads include: sedimentation using conical or inclined settlers, centrifugation, acoustic resonance, spin filtration, and microfiltration. These techniques often use sophisticated equipment, requiring significant capital expenditure as well as routine maintenance and...

Pharmaceutical Online

 •  April 18

A comprehensive GMP intelligence program includes monitoring of health authority enforcement actions, including FDA Form 483s, Establishment Inspection Reports, warning letters, recalls, import alerts, consent decree agreements, and EU reports of GMDP noncompliance. This article presents the most recent publication of GMP drug product inspection...

Pharmaceutical Online

 •  April 18

The major discovery that poliovirus can be grown in cell cultures of nonneural origin, including kidney epithelial cells, changed the methodology for producing viral vaccines. As kidney cell lines were introduced and virus growth was demonstrated, the use of primary cells gradually gave way to the far less expensive and more easily manipulated...

Pharmaceutical Online

 •  April 17

We are on the verge of a digital revolution in every corner of the healthcare sector, but there are no guarantees that we’ll succeed in the life sciences. The most successful stakeholders will be those who understand the full potential as well as the limits of these technologies and know how to integrate smart, patient-centered initiatives, know...

Pharmaceutical Online

 •  April 16

FDA officials and leaders in the pharma and medical device spaces agree artificial intelligence (AI) tools could enable a step change in quality management in those industries. Areas that could be impacted include supply chain management, lot release, manufacturing, compliance operations, clinical trial end points, and drug discovery, among...

Pharmaceutical Online

 •  April 16

By Jason Brown, Paula Decaria, Nephi Jones, Tommy Smith, Dmitrij Bugajev, Juozas Šiurkus Advances in single-use bioprocess technology have led to the rapid adoption of single-use bioreactors (S.U.B.s) across a broad range of applications within the biotechnology industry. However, the aggressive performance demands common in industrial microbiology...