Pharmaceutical Technology

JULY 25, 2022

The FDA knows that developing specialty generics, particularly generic injectable products, can be challenging. You need good production, good science and engineering, and you need good lawyers. Drugs with an AB rating meet the required bioequivalence. For smaller companies, the last two are more problematic,” he says.

Drugs 298

Drugs Manufacturing Production Pharmacy 298

The Pharma Data

DECEMBER 27, 2020

The drug is a humanized IgG4 monoclonal antibody that blocks CCR5 and is being developed for COVID-19, HIV and metastatic triple-negative breast cancer. platform and its large-capacity VV Cop TK”RR” oncolytic virus, engineered to encode both a Treg-depleting human recombinant anti-CTLA4 antibody generated by BioInvent’s n-CoDeR/F.I.R.S.T.

Trials 52

Trials Antibody Gene Therapy Clinical Trials 52

Pharmaceutical Technology

JANUARY 6, 2023

It requires having access to proper techniques and skill sets, state-of-the-art equipment, process scientists and engineers who have a deep understanding of Quality by Design (QbD) principles, and methods for product and process characterisation. Optimising development and scale-up. Particle distribution. Grittiness.

Production 130

Production Manufacturing Development Bioequivalency 130

The Pharma Data

MAY 3, 2021

AstraZeneca has drawn criticism for saying it can’t share its vaccine tech with the WHO because it has no engineers available ‘to brief people and train them’ ( BI ). Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ). Coronavirus Pandemic.

Gene Therapy 52

Gene Therapy Vaccination Vaccine Bioequivalency 52