Drug Development

Articles

BioVectra will open its new microbial fermentation and complex chemistry site, including the capability to handle high-potency APIs, by the end of 2017.


BioVectra Builds Fermentation and Complex Chemistry Facility in Nova Scotia

Ajay Pazhayattil*, M.Pharm, DBA, Ajay.Pazhayattil@capcium.com, is vice-president, Scientific and Regulatory Affairs at Capcium.

Jana Spes is Vice-President, Technical Operations, Apotex, jspes@apotex.com.

Rakesh Singh Chaudhary is scientistâtechnical operations TSS at Apotex Inc. 

The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies. 

Continuous Manufacturing: A Generic Industry Perspective

The company will expand its production facilities in Carlow and Cork to meet increased global demand for its medicines and vaccines produced in Ireland. 

MSD Announces EUR280 Million Investment in Ireland and 330 New Jobs

CBER is moving forward with the development and approval of regenerative medicine advanced therapies.

FDA Looks to Advance Regenerative Medicine

Ablynx will receive EUR15 million in milestone payment following Merck’s decision to advance ALX-1141 into clinical development. The nanobody was developed by Ablynx under a 2011 collaboration between both parties. 

Novel Nanobody for Osteoarthritis Enters Clinical Development

The agency released several new and revised guidance documents regarding product-specific generic drug development.


FDA Releases New and Revised Product-Specific Generic Drug Guidance

Catalent has signed an agreement with Therachon to support preclinical and clinical development of TA-46, a novel protein being developed to treat achondroplasia.

Catalent Biologics Collaborates with Therachon to Develop Novel Protein Therapy for Achondroplasia

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.

Formulation and Drug Delivery