Drug Development

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Articles

Andrew Bulpin, executive vice president of EMD Millipore’s Process Solutions Business, speaks to Pharmaceutical Technology about the trends shaping the biopharmaceutical manufacturing industry.

Cell Culture, Single Use, and the Evolving Biopharmaceutical Landscape

Randy Wald, senior research fellow at Bend Research, part of Capsugel Dosage Form Solutions shares insights on trends shaping the evolving solid dosage manufacturing landscape, including advances in excipients and the impact on formulation development and manufacturing processes.

Key Considerations in Excipients Selection for Solid Dosage Forms

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

The company adds a few new arguments-as well as new stakeholder support-to its Citizen Petition on biosimilar naming.

AbbVie Amends its Citizen Petition to FDA

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

The complex task of stabilizing proteins is made more challenging due to the limited number of approved excipients.

Excipient Selection for Protein Stabilization

Companies in the US will now have the opportunity to tap into Hermes Pharma’s technical expertise in effervescent and chewable tablets, instant drinks, lozenges, and orally disintegrating granules (ODGs).

Hermes Pharma Expands Formulation Services to US Market

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

CMC Biologics to Manufacture mAbs for the Treatment of Malaria

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

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.

Formulation and Drug Delivery