Contamination, Contract Manufacturing and Production

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

Roots Analysis

APRIL 15, 2024

Further, the manufacturing of biologics fill finish is a highly complex and cost-intensive process. For instance, small biotech companies enter into agreements with fill finish manufacturing companies due to lack of in-house capacity.

Manufacturing

Manufacturing Production Contract Manufacturing Contamination

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. Pharma manufacturing facilities in Andhra Pradesh and Telangana accounted for 22.5% © GlobalData. ©GlobalData.

Manufacturing

Manufacturing Generic Drugs Contract Manufacturing Production

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 to costs and places higher demands on PPE due to risks of exposure: “Production is more costly.

Containment

Containment Manufacturing Production Contract Manufacturing

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). Covid-19 vaccines stay in the spotlight.

Manufacturing

Manufacturing Drugs Vaccination Vaccine

HPAPIs – Current Interest of the Pharmaceutical Industry

Roots Analysis

OCTOBER 24, 2023

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

Manufacturing

Manufacturing Hormones Contamination Contract Manufacturing

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

FDA Law Blog

JANUARY 1, 2024

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

Manufacturing

Manufacturing Production Drugs FDA Compliance

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

Roots Analysis

JANUARY 12, 2023

Over the years, several advanced and innovative automation tools and technologies have been developed; these have been demonstrated to hold the potential for significant reduction in the cost associated with the manufacturing of advanced therapy medicinal products, thereby, making such products more affordable.

Manufacturing

Manufacturing Production Contamination Medicine

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. Download the whitepaper below to find out more about ILC Dover’s flexible solutions for protecting the entire supply chain.

Containment

Containment Contamination Contract Manufacturing Production

Athersys to Host a Virtual Investor Day

The Pharma Data

JANUARY 27, 2021

MultiStem ® cell therapy is a patented regenerative medicine product candidate in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage. About MultiStem ®.

Clinical Trials

Clinical Trials Clinical Trials Production Trials

Athersys Announces Three Appointments to Board of Directors

The Pharma Data

NOVEMBER 15, 2020

MultiStem ® cell therapy is a patented regenerative medicine product candidate in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage. About MultiStem ®.

Clinical Trials

Clinical Trials Clinical Trials Production Trials

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

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. This guidance may be adjusted in the future as additional contracts are executed. Hospital products, which grew 10% operationally to $2.3

Vaccination

Vaccination Vaccine Production Sales

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. Once set up and validated, the control process must guarantee constancy during production so that the results are as expected.

Manufacturing

Manufacturing Production Containment Contamination

Optimizing lyophilization cycle times and improving stability for complex injectables

Pharmaceutical Technology

JANUARY 12, 2023

– about the advantages and challenges of product lyophilization, developing lyophilization processes on site at their Bloomington, Indiana plant, and the importance of continuing research. Biologics often have strict temperature requirements to ensure the product remains stable. KB: Primarily stability.

Production

Production Contamination Development Manufacturing

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

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

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

Pharmaceutical Technology

JUNE 14, 2023

According to GlobalData’s Drugs database, 97% of marketed drugs are small molecule products and analysis shows an increased CMO appetite for specialized capabilities, with controlled substance and containment facilities highly sought after [i].

Containment

Containment Manufacturing Contract Manufacturing Bioavailability

Clinical Research Informer

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

Indian pharma manufacturing: rising investment in Andhra Pradesh

Trending Sources

API landscape in 2022: Drivers and solutions for small molecules

CMO Moves: Regulatory catalysts for drug manufacturing-April

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

How API CMOs can improve containment capabilities without facility acquisition

Athersys to Host a Virtual Investor Day

Athersys Announces Three Appointments to Board of Directors

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

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

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

Optimizing lyophilization cycle times and improving stability for complex injectables

The rising importance of containment in small molecule drug development

FDA pens stinging report on Emergent COVID vaccine plant

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

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