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

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Articles

A Q&A with Joe Cascone, director of potent pharmaceutical development at Metrics, moderated by Patricia Van Arnum. Discussion of the key considerations made in facility design, equipment selection, and operations to achieve desired levels of containment.

Achieving Containment in High-Potency Manufacturing: A Case Study for Solid Dosage Manufacturing

Highly potent APIs (HPAPIs) represent a growing area of interest for the pharma industry. Mark Griffiths, CEO of Carbogen Amcis AG, explains why.

Highly Potent; Highly Challenging?

Henrik Schwartzbach is a Senior Process Technologist at GEA Niro.

Henrik Schwartzbach, senior process technologist at GEA Niro, explins why spray drying is seeing increased uptake in the pharma industry.

Achieving Aseptic Drying With Spray Drying Technologies

Recently, there have been many innovations in the latest techniques and technologies in API purification. In particular, the trend to single-use systems has had a significant impact on processes.

API Purification

FDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for scored tablets.

FDA Publishes Draft Guidance on Tablet Scoring

Using information technology tools to enhance process understanding helps reduce variability that can affect speed to market.

Biosimilars Increase the Need for IT to Reduce Variability

Amy Ritter was Scientific Editor, BioPharm International.

Since the passage of the BPCI Act in 2009, manufacturers have been waiting for guidance from FDA on what that approval process will look like.

For Biosimilars, No “One Size Fits All”

Xevo TQD provides ultimate consistency between analyses; instrument to instrument, lab to lab; both the advanced technology of the ACQUITY UPLC System and the robust universal ion source architecture on the Xevo TQD guarantee flexibility and dependability.

Rapid identification of Genotoxic Impurities in Tablets with Xevo TQD

Michelle Hoffman, editorial director of Pharmaceutical Technology.

Are biosimilars the next big thing or just the next big bubble?

Biosimilars or Bust

A path to personalized medicines creates a new paradigm for development and manufacturing.