Stability Testing of Biopharmaceuticals.

Stability testing of a drug substance or a finished product is a vital part of the data package submitted in support of new drug applications or marketing authorisations. The principle ethos of stability testing is to provide evidence to a regulatory body that the quality of the product or raw material does not vary with time or under the influence of a range of other factors including temperature, humidity and light.

Spotlight

TOPRA

TOPRA, The Organisation for Professionals in Regulatory Affairs, is a non-profit, non-political organisation which seeks to advance the status of the regulatory profession through education, and provision of information to its members.

OTHER WHITEPAPERS
news image

Navigating the Drug Development Pipeline: Expertise for Highly Potent API Product Handling

whitePaper | July 11, 2022

The expansion in the development and manufacturing of highly potent active pharmaceutical ingredients (HPAPIs) and complex active pharmaceutical ingredients (APIs) has grown tremendously as demands in healthcare to bring newer therapies to market quicker increase.

Read More
news image

The Never-Normal Future of Manufacturing

whitePaper | September 24, 2022

Let’s just say what we’re all thinking: 2020 was rough. It threw pretty much every element of our lives into disarray, and we suddenly had to become experts at navigating a new way of working, schooling and socializing.

Read More
news image

PHARMACEUTICAL KEY ACCOUNT MANAGEMENT: HARNESSING SALES EXPERTISE TO DEVELOP UNIFIED STAKEHOLDER RELATIONSHIPS

whitePaper | November 25, 2022

To meet the needs of a growing range of external stakeholders, many life science companies are changing the ways that they disseminate information.

Read More
news image

Regenerative Medicine

whitePaper | September 16, 2022

T wice a year, we survey the cell and gene therapy landscape and ARM’s initiatives to advance the sector and provide an update to our members.

Read More
news image

Why Deck 7

whitePaper | January 1, 2020

With over 2,800 campaigns each year delivered through a team of 300+ digital, data, and technology specialists, Deck 7 is a first resource for B2B demand generation services for marketers worldwide. Clients leverage Deck 7’s multichannel content marketing services and Media 7’s network of 30+ online publications for content syndication to engage over 95 million buyers across 16 industries and 120+ countries.

Read More
news image

Assessing drug target association from biological evidences

whitePaper | July 7, 2022

The full drug target profile identification is many times a necessary step in drug development process. Recently, the move to a more holistic approach in drug discovery has resulted in the increasing use of cell-based assays to discover new biologically active small molecules.

Read More

Spotlight

TOPRA

TOPRA, The Organisation for Professionals in Regulatory Affairs, is a non-profit, non-political organisation which seeks to advance the status of the regulatory profession through education, and provision of information to its members.

Events