Roots Analysis

JANUARY 14, 2024

With the increased interest and gradual shift of investment from small molecule drugs to biologics and the establishment of several biologics manufacturing companies / biologics CMOs, more than 250 biologic therapies and vaccines have been developed, globally. Like all drugs, biologics are regulated by the FDA.

Contract Manufacturing 40

Contract Manufacturing Manufacturing Protein Bacteria 40

Pharmaceutical Technology

NOVEMBER 30, 2022

Each month, Pharmaceutical Technology takes a look at recent decisions taken by regulatory and reimbursement agencies and identifies the key manufacturing players that can be impacted by them. Following similar decisions by the American and European regulators, Swissmedic approved Pfizer/BioNTech’s bivalent Comirnaty booster.

Manufacturing 130

Manufacturing Packaging Packaging Drugs 130

pharmaphorum

JUNE 2, 2021

Capacity to supply Moderna’s COVID-19 vaccine in Europe could be swelled by round 300 million doses a year, following an agreement to set up a new production line at contract manufacturer Lonza. Full approval means it could be used routinely in future as an annual booster, much like the seasonal influenza vaccine.

Vaccination 52

Vaccination Vaccine Contract Manufacturing Production 52

pharmaphorum

JUNE 14, 2021

The failings at a Baltimore, US factory making Johnson & Johnson’s COVID-19 vaccine mean that millions of doses of the shot will have to be jettisoned, according to an FDA update. The plant remains shuttered, so all the 21 million doses of J&J’s one-shot vaccine have been supplied from its facility in the Netherlands.

Vaccination 52

Vaccination Vaccine Manufacturing Contract Manufacturing 52

Roots Analysis

OCTOBER 3, 2023

The feeding strategy can be modified accordingly, in order to regulate cell growth and fermentation. In the recent past, the advent of COVID-19 heightened the demand for vaccines, the supply of which was indispensable for the government led mass vaccination programs. As a result, the products are also removed continuously.

Vaccination 40

Vaccination Vaccine Production Manufacturing 40

Pharmaceutical Technology

JULY 29, 2022

The need for the sector to rapidly research, develop and test new vaccines had always been of critical importance, but in the context of a global pandemic and national lockdowns, it became even more so, with each part of the supply chain required to face up to the full weight of the task. Government policy and regulation: Index score 6.96/10.

Manufacturing 147

Manufacturing Production Contract Manufacturing Engineer 147

Camargo

FEBRUARY 4, 2021

This situation reflects several issues with accelerated approvals, perhaps foretelling issues with the recent Emergency Use Authorizations (EUAs) of COVID-19 vaccines. For vaccines, the patient alone is involved in the risk assessment. In the instance of Makena, expecting mothers must also factor in their desire for a viable baby.

Development 131

Development Production Drugs Manufacturing 131

The Pharma Data

MAY 4, 2021

to $3.65, Primarily Reflecting Updates to Anticipated Contributions from BNT162b2 Partially Offset by Additional R&D Expenses for Vaccines to Protect Against COVID-19 as Well as Other mRNA-Based Development Programs and COVID-19 Antivirals. Billion Doses Expected to be Delivered in 2021 Under Signed Contracts as of Mid-April 2021.

Vaccination 40

Vaccination Vaccine Production Sales 40