Pharmaceutical Technology

NOVEMBER 17, 2022

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.

Containment 130

Containment Contamination Contract Manufacturing Production 130

The Pharma Data

JANUARY 27, 2021

The following risks and uncertainties may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements: our ability to raise capital to fund our operations, including but not limited to, (..)

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

Drug Discovery World

FEBRUARY 2, 2023

So extreme and so complex are the special safety and handling measures required during the manufacture of RRx-001 that only a handful of highly specialised contract manufacturing organisations (CMOs) in the world possess the necessary qualifications, expertise, and experience to make and store it.

Manufacturing 52

Manufacturing Clinical Trials Clinical Trials Drugs 52

The Pharma Data

NOVEMBER 15, 2020

The following risks and uncertainties may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements: our ability to raise capital to fund our operations, including but not limited to, (..)

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 53

Vaccination Vaccine Contamination Contract Manufacturing 53

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. This prevents contamination of the elements by the sampled powder.

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

The Pharma Data

MAY 4, 2021

billion, primarily driven by Pfizer CentreOne, Pfizer’s contract manufacturing operation, reflecting sales of legacy Upjohn products to Viatris (4) and remdesivir to Gilead Sciences Inc., Hospital products, which grew 10% operationally to $2.3 down 7%, which reflects relatively stable U.S.

Vaccination 40

Vaccination Vaccine Production Sales 40

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

Containment challenges and opportunities High containment facilities guard against exposure to extremely potent products and cross-contamination. GlobalData’s Contract Small Molecule API Manufacturing Industry by the Numbers (2021) analyzed 2,787 small molecule API contract manufacturing facilities.

Containment 130

Containment Manufacturing Contract Manufacturing Bioavailability 130