Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.

Reshaping Dosage Forms

This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.

Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime Proxetil

Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.

Frontrunners in Bispecific Antibodies

Topic

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. 

Articles

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

Saneca has been granted approval to manufacture and supply multiple dosage forms to Russia.  

Saneca Pharma Receives GMP Certification from Russian Regulator

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

Catalent has been working together with Lexicon to develop the drug formulation of Xermelo, which has now been approved by FDA for the treatment of carcinoid syndrome diarrhea.

Catalent to Manufacture Lexicon Pharmaceuticals' Orphan Drug Xermelo

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

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.