The Pharma Data

JANUARY 27, 2021

Some of the more significant known risks that we face are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as therapeutics, including the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

The Pharma Data

NOVEMBER 15, 2020

Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. She earned a BA from Durham University, U.K., and an MBA from Harvard Business School. Most recently, she was a senior executive at Celgene Corporation, where she led corporate strategy from 2012 to 2017.

Clinical Trials 40

Clinical Trials Clinical Trials Production Trials 40

pharmaphorum

APRIL 6, 2021

AstraZeneca is shifting production of its COVID-19 vaccine away from a plant in Baltimore which also makes Johnson & Johnson’s shot, after human error resulted in the contamination of 15 million doses. . Emergent claims however that one batch of the vaccine simply failed quality controls, and no contamination took place.

Vaccination 56

Vaccination Vaccine Contamination Contract Manufacturing 56

The Pharma Data

MAY 4, 2021

Following the completion of the spin-off of the Upjohn Business (4) in the fourth quarter of 2020, Pfizer now operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales and distribution of biopharmaceutical products worldwide. in December 2019; and.

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharmaceutical Technology

APRIL 12, 2023

The ingredients used in these drugs are high potency, even at small doses, and pose a risk to both human health and cross-contamination with other drugs in a manufacturing environment. A robust manufacturing process that leads to a consistently high-quality product is a major business goal for pharmaceutical R&D.

Manufacturing 130

Manufacturing Production Containment Contamination 130

Pharmaceutical Technology

DECEMBER 6, 2022

Manufacturing these highly potent and often cytotoxic drugs introduces many risks for operators and the environment. Cross-contamination of standard products with highly potent ones is another key concern. Between 2018 and 2020, 58% of the small molecule API contract manufacturing sites purchased worldwide offered containment.

Containment 130

Containment Development Drugs Contract Manufacturing 130

Pharmaceutical Technology

JANUARY 12, 2023

Risks for cross-contamination when handling cytotoxic and non-cytotoxic products in the same facility must be properly assessed, using state-of-the-art organisation procedures, technical standards, and current industry guidance. United Kingdom. United States. Afghanistan. Åland Islands. American Samoa. Antarctica. Antigua and Barbuda.

Production 130

Production Contamination Development Manufacturing 130

pharmaphorum

APRIL 22, 2021

The FDA’s closeout letter refers specifically to the cross-contamination incident that led to 15 million doses of the J&J shot being jettisoned when ingredients destined for AstraZeneca’s AZD1222 shot were accidentally mixed into vials of the J&J product.

Vaccination 52

Vaccination Vaccine Contamination Contract Manufacturing 52

Pharmaceutical Technology

JUNE 14, 2023

The number of high-potency drug approvals has increased over the last decade, driven by the increasing use of APIs (Active Pharmaceutical Ingredients) in the pipeline and among marketed drugs. Containment challenges and opportunities High containment facilities guard against exposure to extremely potent products and cross-contamination.

Containment 130

Containment Manufacturing Contract Manufacturing Bioavailability 130