Introduction to the manufacturing of biologics

Ditte Funding | 12th December 2016

The last decade has seen the rapid growth of biologics in the pharmaceutical market, making them a key sector to watch in the coming years. Biopharma made up 22% of big pharma companies’ sales in 2013, with this number being expected to rise to 32% of sales by 2023. With the growing popularity of these products, it’s important to understand the opportunities and threats they present to pharma companies.

Associate Consultant Ditte Funding takes us through how biologics are made, what makes them unique, and what it all means for pharma companies.

What is a biologic?

Before looking at how to manufacture them, it’s important to first understand what a biologic is. The definition of a biologic isn’t always clear, and what’s considered a biologic is constantly being updated and tweaked as new products are introduced to market. However, the broad definition of a biologic is they are created by either a microorganism or a mammalian cell, and are large, complex molecules; the majority of which are proteins or polypeptides. Examples of biologics include blood or blood products, gene therapies, vaccines, and cell therapies.

There is a significant distinction that needs to be made between traditional small molecule pharmaceuticals (such as aspirin), and biopharmaceuticals. Biologics differ from small molecule drugs in their cost, production, administration, and clinical efficacy. Small molecule drugs are usually chemically synthesised, simple, and have a very well-defined structure. Whereas biologics, or large molecule drugs, are difficult to define and characterise. 

Biologics present great value, as they are highly specific molecules that tend to target more difficult to treat populations; it seems that biologics may become a primary tool for targeting hitherto untreatable diseases. However, in order for biologics to be widely used treatments in the future, they must be manufactured at the right cost and the right scale.

Download the full article with process diagram below

How to plan, execute and refine an excellent congress experience

Dolan Desai, Dale Choate | 21st June 2017

Medical congresses are one of the most important and intensive marketing activities a company can undertake. Here Dolan Desai and Dale Choate give you the practical tools and tips you need to create a leading congress experience.

read more

US Capitol dome

21st Century Cures Act: a commercial perspective on how the new FDA regulation could revolutionise use of RWE and analytics in healthcare

David Cooney | 15th June 2017

The 21st Century Cures Act was signed into law last December during the Obama administration. It brings numerous changes to the US drug development landscape, impacting patients, academia, research institutions, and industry. Over the last number of months Blue Latitude have been engaging with US pharma companies to help our clients understand its implications and how it could be leveraged.

read more

surfer-perspective-4-executional-excellence

The Executional Excellence issue of Perspective magazine is live

Blue Latitude Health | 23rd May 2017

What drives us at BLH is the opportunity to make a real difference – and for our clients, that difference is measured both in customer outcomes and commercial outcomes. In the Executional Excellence edition of Perspective magazine, we explore topics around the ‘executional excellence’ theme – creating work that works. 

read more