Outsourcing

Mayne Pharma plans to double oral-dose manufacturing space and expand contract services.

Recipharm will be responsible for the supply of the remaining clinical-trial material and ongoing future commercial supply of RHB-105, the lead drug candidate developed by RedHill for the treatment of Helicobacter pylori bacterial infection.

WuXi's Laboratory Testing Division will be the exclusive supplier of laboratory testing services for Hong Kong-based Lee's Pharm.

Cytovance Biologics anticipates continued expansion plans following acquisition by Hepalink USA

With this acquisition, Source BioScience is now able to offer integrated solutions to customers, with environmentally controlled storage in combination with the required up- or downstream analytical testing services.

*This article is an opinion piece and does not necessarily represent the views of BioPharm International.

Companies in the US will now have the opportunity to tap into Hermes Pharma’s technical expertise in effervescent and chewable tablets, instant drinks, lozenges, and orally disintegrating granules (ODGs).

CMC Biologics will manufacture monoclonal antibodies (mAbs) and provide process development services for the PATH Malaria Vaccine Initiative.

Catalent selects advisory board members to complement Redwood Bioscience Scientific Advisory Board.

Contract research, development, and manufacturing organizations (CROs, CDMOs and CMOs) are embracing lean manufacturing, while Big Pharma is applying it, not so much for inventory management, but to improve supply chain visibility and control.

FDA issues guidance regarding fees for drug compounding outsourcing facilities.

Biopharma companies are outsourcing more jobs to cut costs.

The YDP30 printer from Sartorius automatically performs thermal transfer or direct thermal printing, without the need to change settings, to meet requirements for fade-resistant printout in regulated areas, such as quality-control laboratories.

Create an efficient global labeling strategy that is compliant with both electronic and paper-based package-insert requirements.

Contract development and manufacturing organizations join forces to address legislative, regulatory, and business concerns in the Pharma & Biopharma Outsourcing Association.

What if the expanding pipeline isn’t enough to fuel CMO growth?

Driven by competitive pressures and using models pioneered in other industries, pharmaceutical companies are extending collaboration efforts well beyond their walls.

Ignoring a contract partner’s ability to handle highly potent APIs (HPAPIs) safely may have serious consequences. Drug owners and contract service providers alike must understand the complexities and liabilities involved in working with HPAPIs.

After a long wait for the new elemental impurities guidelines, the bio/pharma industry must now look ahead to implementation and take action.

Cloud computing has made it easier for pharma companies and their contract partners to gain visibility into their combined supply chains.

Within the past few years, key players have left the sterile manufacturing business. Can new technology and investment revitalize this critical market?

Currently, pharma has only scratched the surface of the potential value of repurposing drugs, says consultant Hermann Mucke. Contract service partners are playing a more prominent role, but could play an even larger one in these efforts.

Sponsors and contract partners alike should not assume that upcoming US federal deadlines will be as elastic as California’s were.

Investment in Powdersize adds particle-size control solutions to Xcelience’s capabilities.

Lupin acquires businesses in Germany, the US, Russia, Brazil, and South Africa.