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

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

Articles

The Biosimilars Forum, along with numerous House members, advocated for the use of unique J-codes for biosimilars in a recent letter to CMS.

Regulators Call for the Revision of Part B Reimbursement Rules for Biosimilars

The company’s Scotland-based facility has successfully completed a scheduled inspection by the UK’s MHRA; there were no critical or major observations noted.

Symbiosis Pharmaceutical Services Completes Successful Sterile Inspection

Flexion will have a dedicated manufacturing suite at Patheon's Swindon, England facility for Flexion's osteoarthritis steroid drug product.

Flexion Collaborates with Patheon to Manufacture Osteoarthritis Treatment

Geoff Carr is the Director of Analytical Development at Patheon located in Mississauga, Ontario. His email is geoff.carr@patheon.com.

A study of root cause in stability samples suggests the need for tighter control of the sodium lauryl sulfate manufacturing processes.

Black Specks in Tablet Stability Samples

US generics manufacturer Amneal acquires a former J&J plant in Ireland.

Amneal Purchases Manufacturing Site in Ireland

Aprecia Pharmaceutical’s SPRITAM levetiracetam gains FDA approval for the treatment of epilepsy.

FDA Approves First 3D-Printed Drug Product

Michelle Frisch, MBA, is senior manager, Global Technical Systems, Powder Systems Limited, and a member of the AGS Standards Committee; michelle.frisch@powdersystems.com.

Brian G. Ward, PhD, CChem, FRSC, is the owner of Barrier Concepts and a member of the AGS Standards Committee; briangward@me.com.

Engineered containment performance testing is a more robust method for validating containment systems than worker-exposure measurement methods.

Environmental Containment Performance—Is There Accountability?

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Taking the Pulse of Manufacturing Trends and Equipment Use

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

Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.

The Potential of Perfusion

Agnes Shanley is senior editor of Pharmaceutical Technology.

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.