Manufacturing, Biologic Drugs

Small-Molecule API CMOs Are Thriving

October 02, 2015

Despite emergence of biologics, small-molecule APIs benefit from industry growth.

Trends in Biologics Drug Delivery

September 25, 2015

There is growing interest in the development of liquid formulations in prefilled syringes and autoinjectors, which offer convenience and ease of administration in a home setting.

Industry Expert Q&A with Robin M. Silva

September 02, 2015

Industry Expert Q&A with Robin M. Silva, Partner, Morgan, Lewis, and Bockius LLP

Knowledge-Sharing and Networking at the CPhI Pre-Connect Congress

August 28, 2015

The Pre-Connect Congress will explore pharma industry trends, such as mergers and acquisitions, the biologics market outlook, and innovation in drug delivery among others.

Biosimilars and Follow-on-Biologics Market to Hit $35 Billion Globally by 2020

August 28, 2015

Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.

CMC Biologics to Manufacture mAbs for the Treatment of Malaria

August 13, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

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

Shifting the Focus from Testing to Manufacturing

July 07, 2015

A study now underway on vaccine manufacturing examines the effects of focusing on consistency during manufacturing, instead of post-production testing.

Testing the Stability of Biologics

July 02, 2015

Biologics exhibit greater variability in stability testing than do small-molecule drugs, and maintaining a stable test environment is crucial.

FDA Issues Guidance on Allowable Excess Volume for Injectables

June 24, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.

PTSM: Pharmaceutical Technology Sourcing and Management

Small-Molecule APIs Still Play a Big Role

May 31, 2015

Despite the buzz about biologic-based drugs, small molecule-based drugs are still the mainstay treatment.