Drug Development

Articles

Aptar Pharma’s e-Lockout device uses advanced electronic technology to limit the number of doses available during a 24-hour period, thereby ensuring safe patient compliance to Takeda’s pain-relieving nasal spray.

EMA Approves First Electronic Lockout Device for Pain Management

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.

Kill the Bioburden, Not the Biological Indicator

Catherine Shaffer is a contributing writer to BioPharm International, cathshaffer@gmail.com.

A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.

Ensuring the Biological Integrity of Raw Materials

Joerg Zimmermann is director of Process Development and Implementation at Vetter, www.vetter-pharma.com

Prefilled dual-chamber cartridges offer several advantages. Several steps should be taken to determine if a dual-chamber system is viable for a lyophilized injectable drug product.

Developing an Injectable Compound for a Dual- Chamber Delivery System

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.

Single-Use Bioreactors Have Reached the Big Time

Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.

Cost Considerations Drive Lean Technology in Biomanufacturing

The program aims to make biosimilars for the treatment of cancer more widely available in middle- and low-income countries.


WHO Launches Biosimilar Pilot Program

EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.


EMA Promotes Understanding and Use of Biosimilars

Forecasts were lowered, Reuters reported, due to reduced drug approvals and increased competitive pressures.

US Prescription Drug Spending to Hit $610 billion in 2021, according to Quintiles/IMS

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.

Formulation and Drug Delivery