Search results for " pharmaceutical"
Article
The Lifecycle Change of Process Validation and Analytical Testing
If adopted correctly, this guideline is good news for the regulator, the pharmaceutical manufacturer, and the patient because we will see more robust, reliable, and better value products brought to ma…
Article
The Future of Biopharma
In response, most large pharmaceutical companies are now devoting increasing development efforts on biopharmaceuticals rather than small molecule drugs. Some are now spending 40% or more of their R&D …
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Coffman, Christopher Gallo, and Ranga Godavarti
ABSTRACT
In recent years, most pharmaceutical companies have focused on the development of monoclonal antibodies (mAbs). Increasing upstream t…
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
In continuous, there's always a start-up phase, a running phase, and then a shut down or end-of-process phase—and pharmaceutical has kind of been slow to this game. Let's face it, there are plenty of …
Article
Top Process Development Trends for 2021 and a Look into 2022
… set forth by the FDA and ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). To help with this, an independent structured assessment process th…
Article
Maximum Output Starts with Optimized Upstream Processing
“This increased demand impacts equally classical pharmaceutical capacity and CDMO capacity as it is the product that is important,” Morello says. “In that perspective,” he adds, “it was interesting to…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
“The knowledge level for some of the required production techniques, such as the formulation of lipid nanoparticles, is still limited within the pharmaceutical industry. We can expect to accrue even m…
Article
Reimagining Affordable Biosimilars
399-416
ICH, Q8(R2) Pharmaceutical Development, Current step 4 (2009).
A.S. Rathore, I.S. Krull, and S. Joshi, LCGC North Am. 36 (6) 376–384 (2018).
W.C. Lamanna, et al., Expert O…
Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Stability studies on these buffer concentrates following International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q7 guidelines (6), ex…
Article
The Importance of Partnering for Bioanalytical Studies
Hence, a concerted effort was made by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to generate a harmonized global guidance document th…