Better CMC Organisation in Small Pharma Drug Development

Chemistry, Manufacturing and Controls (CMC) is a vital part of the drug development process. A CMC strategy gives companies a template for bringing a drug through the early clinical stages all the way to commercial manufacturing.  The CMC process has...

1 month ago
Bioprocess,Biomanufacturing,CMC,Regulatory Affairs,News

Better CMC Organisation in Small Pharma Drug Development

Chemistry, Manufacturing and Controls (CMC) is a vital part of the drug development process. A CMC strategy gives companies a template for bringing a drug through the early clinical stages all the way to commercial manufacturing.  The CMC process has...

1 month ago

Solving Regulatory Issues in Cell and Gene Therapies

Cell and Gene Therapies (CGTs), experimental technologies to treat or cure diseases using the body’s cells, have been on the ascendant for some time now. As promising as they are, CGTs have consistently moved forward faster than regulatory agencies can...

1 month ago
Bioprocess,CGT,Biomanufacturing,Regulatory Affairs,News

Solving Regulatory Issues in Cell and Gene Therapies

Cell and Gene Therapies (CGTs), experimental technologies to treat or cure diseases using the body’s cells, have been on the ascendant for some time now. As promising as they are, CGTs have consistently moved forward faster than regulatory agencies can...

1 month ago

How will COVID-19 Change Biomanufacturing?

The COVID-19 pandemic proved how ill-equipped the world was for a virus of that scale and potency. In the first months of the pandemic, businesses across all sectors scrambled to prepare their processes and supply chains for the coming disruption,...

2 months ago
Bioprocess,CGT,Biomanufacturing,Regulatory Affairs,News

How will COVID-19 Change Biomanufacturing?

The COVID-19 pandemic proved how ill-equipped the world was for a virus of that scale and potency. In the first months of the pandemic, businesses across all sectors scrambled to prepare their processes and supply chains for the coming disruption,...

2 months ago

The Challenges of CMC in Cell and Gene Therapies

Safety is one of the most important aspects of drug development. The need for a drug to be efficacious, consistent and non-harmful to humans is vital for its success. And where a treatment is new, highly variable, and can involve...

6 months ago
Bioprocess,CGT,Biomanufacturing,CMC,Regulatory Affairs,News

The Challenges of CMC in Cell and Gene Therapies

Safety is one of the most important aspects of drug development. The need for a drug to be efficacious, consistent and non-harmful to humans is vital for its success. And where a treatment is new, highly variable, and can involve...

6 months ago

How to Select a CMO in Biomanufacturing

Experts often regard biomanufacturing efficiency as the most important part of global bioprocessing. But efficiency can be almost impossible as companies juggle hundreds of priorities across dozens of areas in the pipeline. Best practice can easily be subsumed by a...

8 months ago
Bioprocess,Biomanufacturing,News

How to Select a CMO in Biomanufacturing

Experts often regard biomanufacturing efficiency as the most important part of global bioprocessing. But efficiency can be almost impossible as companies juggle hundreds of priorities across dozens of areas in the pipeline. Best practice can easily be subsumed by a...

8 months ago

Trending Innovations in Cold Chain Processes

As is increasingly known in the pharmaceutical industry, the rise in both trial costs and drug failures has seen a corresponding increase in the need for tight regulations and stricter procedures, to ensure the few successes are not further compromised....

9 months ago
Bioprocess,Biomanufacturing,CMC,News

Trending Innovations in Cold Chain Processes

As is increasingly known in the pharmaceutical industry, the rise in both trial costs and drug failures has seen a corresponding increase in the need for tight regulations and stricter procedures, to ensure the few successes are not further compromised....

9 months ago

Single-Use Technologies: Challenges and Solutions

Since their increased popularisation from the mid-1990s, single- and limited-use technologies (collectively SUTs) have changed the field of biomanufacturing. This has been driven partly by the heavy growth of the pharma market, from $162 billion in 2014 to around $270...

1 year ago
Bioprocess,Biomanufacturing,CMC,News

Single-Use Technologies: Challenges and Solutions

Since their increased popularisation from the mid-1990s, single- and limited-use technologies (collectively SUTs) have changed the field of biomanufacturing. This has been driven partly by the heavy growth of the pharma market, from $162 billion in 2014 to around $270...

1 year ago