Pharmaceutical Technology

JUNE 14, 2023

Many small and mid-cap companies lack the expertise for regulatory compliance and high containment facilities and thus seek to outsource NMEs (New Molecular Entities) requiring special handling. Of those, only 935 (34%) small molecule API facilities offered some type of containment capabilities.

Containment 130

Containment Manufacturing Contract Manufacturing Bioavailability 130

Roots Analysis

APRIL 15, 2024

Availability of innovative platforms / technologies with fill finish contract manufacturing organizations, such as SA25 aseptic filling workstation ( developed by Cytiva ), an isolator-based filling technology capable of filling primary packaging containers for large commercial batches of more than 20,000 units.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

Roots Analysis

MARCH 9, 2022

1] The desired function of excipient in formulation of the medicinal product is to carry the active component to the target site with an active contribution in improving its biological effect, stability, appearance and patient compliance. [2]. Biopharmaceutical Excipient Manufacturing Market.

Manufacturing 52

Manufacturing Marketing Contract Manufacturing Protein 52

FDA Law Blog

JANUARY 1, 2024

The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Summaries of the most striking recently released Warning Letters are included below. Dextrum Laboratories Inc.

Manufacturing 59

Manufacturing Production Drugs Contract Manufacturing 59

Roots Analysis

JANUARY 12, 2023

The key steps involved in the supply chain of cell therapies manufacturing are presented below. However, there are several hurdles associated with the transition of cell-based therapy products from laboratory to clinical scale, such as regulatory compliance, lack of advanced facilities and infrastructure.

Manufacturing 40

Manufacturing Production Contamination Medicine 40

The Pharma Data

NOVEMBER 15, 2020

a publicly traded biopharmaceutical company, from 2012 to December 2019, managing its international, legal, quality, intellectual property and compliance functions, after serving in other executive roles at Acorda starting in 2004. Before joining Acorda, Ms.

Clinical Trials 40

Clinical Trials Clinical Trials Production Trials 40

The Pharma Data

JULY 21, 2021

We believe this collaboration will create opportunity to more broadly distribute vaccine doses to people in harder-to-reach communities, especially those on the African continent.”.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

Pharmaceutical Technology

OCTOBER 27, 2022

Mitigation measures could include the forfeiture of sensitive contracts, the appointment of special compliance personnel or proxy boards consisting of US persons, or even the divestiture of assets or operations. There are already nine Chinese-based companies with 14 US contract manufacturing facilities.

Manufacturing 267

Manufacturing Contract Manufacturing Gene Therapy Gene 267

Roots Analysis

JANUARY 27, 2025

Further, as can be observed from the figure, the microbial CMO market features the presence of small, mid-sized, large and very large companies having the required expertise to offer contract manufacturing services across the globe. Compliance with these regulations, requires substantial time and financial investment.

Marketing 40

Marketing Manufacturing Production Development 40