Contamination and Contract Manufacturing - Clinical Research Informer

How API CMOs can improve containment capabilities without facility acquisition

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

Containment Contamination Contract Manufacturing Production

CMO Moves: Regulatory catalysts for drug manufacturing-April

Pharmaceutical Technology

JULY 14, 2022

Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. In this ongoing series , we put a spotlight on contracts between pharma companies and contract manufacturing organizations (CMOs).

Manufacturing

Manufacturing Drugs Vaccine Vaccination

API landscape in 2022: Drivers and solutions for small molecules

Pharmaceutical Technology

SEPTEMBER 15, 2022

Research by GlobalData (Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition) shows that containment facilities are in high demand as the use of cytotoxic drugs continues to grow. This adds costs and time to the processes involved.

Containment

Containment Manufacturing Production Contract Manufacturing

Outsourcing Biologics Fill Finish Manufacturing : Streamlining the Production Process for Biopharmaceutical Companies

Roots Analysis

APRIL 15, 2024

Additionally, the fill finish manufacturing of biologics is a critical step in the production of biopharmaceuticals as it requires well-equipped facilities with adequate sterile filling and packaging lines to ensure sterility of the product while filling into the final containers.

Manufacturing

Manufacturing Production Contract Manufacturing Contamination

HPAPIs – Current Interest of the Pharmaceutical Industry

Roots Analysis

OCTOBER 24, 2023

This precaution is taken to prevent any potentially harmful contaminant from escaping the production area. This is in contrast to the containment requirements at manufacturing facilities of traditional APIs. Various large scale drug manufacturing companies have installed in-house high potency manufacturing capabilities.

Manufacturing

Manufacturing Hormones Contamination Containment

FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

FDA Law Blog

JANUARY 1, 2024

The letter also stated that the company’s response to the inspection report was “inadequate because it did not include a review of environmental monitoring data in your manufacturing areas, an adequate risk analysis of previously manufactured drug product, or testing of reserve samples from impacted batches.” Dextrum Laboratories Inc.

Manufacturing

Manufacturing Production Drugs Contract Manufacturing

Advancements in Automation of Processes: Key Value Driver for Escalated Interest in Cell Therapies Manufacturing Domain

Roots Analysis

JANUARY 12, 2023

Efforts to introduce automation technologies in cell therapies manufacturing are underway, and if implemented successfully, can significantly help in the elimination of human intervention and reduce the risk of contamination.

Manufacturing

Manufacturing Production Contamination Medicine

Athersys to Host a Virtual Investor Day

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

Clinical Trials Clinical Trials Production Trials

Athersys Announces Three Appointments to Board of Directors

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

Clinical Trials Clinical Trials Production Trials

Indian pharma manufacturing: rising investment in Andhra Pradesh

Pharmaceutical Technology

APRIL 4, 2023

Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. Telangana’s pharma manufacturing industry is well established and continues to have more than double the pharma sites of Andhra Pradesh. © GlobalData.

Manufacturing

Manufacturing Generic Drugs Contract Manufacturing Production

AZ exits US vaccine plant after mix-up spoils J&J’s COVID jab

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

Vaccination Vaccine Contamination Contract Manufacturing

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

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.

Vaccine

Vaccine Vaccination Production Sales

A winning combination: The benefits of micronization and containment in a single installation

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

Containment Manufacturing Contract Manufacturing Bioavailability

Small molecule API: Shining a spotlight on new innovations in milling

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

Manufacturing Production Containment Contamination

The rising importance of containment in small molecule drug development

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

Containment Development Drugs Contract Manufacturing

Optimizing lyophilization cycle times and improving stability for complex injectables

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

Production Contamination Development Manufacturing

FDA pens stinging report on Emergent COVID vaccine plant

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

Vaccination Vaccine Contamination Contract Manufacturing

Clinical Research Informer

How API CMOs can improve containment capabilities without facility acquisition

CMO Moves: Regulatory catalysts for drug manufacturing-April

Trending Sources

API landscape in 2022: Drivers and solutions for small molecules

Outsourcing Biologics Fill Finish Manufacturing : Streamlining the Production Process for Biopharmaceutical Companies

HPAPIs – Current Interest of the Pharmaceutical Industry

FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

Advancements in Automation of Processes: Key Value Driver for Escalated Interest in Cell Therapies Manufacturing Domain

Athersys to Host a Virtual Investor Day

Athersys Announces Three Appointments to Board of Directors

Indian pharma manufacturing: rising investment in Andhra Pradesh

AZ exits US vaccine plant after mix-up spoils J&J’s COVID jab

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

A winning combination: The benefits of micronization and containment in a single installation

Small molecule API: Shining a spotlight on new innovations in milling

The rising importance of containment in small molecule drug development

Optimizing lyophilization cycle times and improving stability for complex injectables

FDA pens stinging report on Emergent COVID vaccine plant

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