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

Kai Lipinski, PhD, is the chief scientific officer of Vibalogics.

Articles

The use of viral vectors as gene delivery and vaccine vehicles has developed rapidly during the last two decades owing to several viral properties. Viruses can infect cells efficiently, often have a broad tissue tropism and can achieve very high levels of either stable or transient transgene expression. Furthermore, their intrinsic immune-stimulatory properties can have adjuvant effects during the treatment of cancer or infectious disease and, importantly for manufacturing scale-up, some viruses can be grown to very high titre (.1012 particles/mL). The development of robust production procedures is essential to move therapeutics that utilize viral vectors into clinical trials, and to make them cost effective for market supply. Here, we describe some of the aspects of production that must be considered and optimized when producing virus vectors on an intermediate or large scale. By drawing examples from our experience of vector production, we show that upstream and downstream processes must be designed..

Aspects of process development for virus vector production to improve quality and quantity

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Merck & Co. initiated a voluntary recall of 11 lots of its Haemophilus influenzae type B vaccine, Pedvaxhib, and two lots of its combination Haemophilus influenzae type B/ hepatitis B vaccine, Comvax.

Merck Issues Voluntary Recall of Two Vaccines

The US Food and Drug Administration issued a rule that clarifies its requirements for current good manufacturing practices for aseptic processing, water standards, and verifications standards.

FDA Issues Rule to Clarify GMP Requirements for Aseptic Processing

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

To keep up with applications, FDA promotes new testing and administrative methods.

Generic Drugs for Everyone

Individualized dosing for specific patient needs has been the goal of medical and pharmacotherapy specialists since they first envisioned pharmacogenetic evaluation. With the measurement of individual levels of metabolism, the optimum dose can be calculated for each individual patient.

What's Next In: Solid-Dosage Formulation

The authors analyzed the effects of complexation as well as the levels of ammonium bicarbonate and crospovidone on tablet wetting time (WT), disintegration time (DT), and percent dissolution efficiency at 60 min (%DE60).

The Disintegration and Dissolution of Nabumetone Dispersible Tablets

Incorporating quality and economy into downstream purification processes can expedite first-in-human clinical trials, product licensure and technology transfer. Experience in the chromatographic purification of biopharmaceuticals enables the use of downstream processing heuristics to produce target molecules in cost-effective processes suitable for regulatory scrutiny.

Economy by design

Michelle Hoffman, editorial director of Pharmaceutical Technology.

Sanofi-aventis entered into an agreement with Chinese authorities allowing Sanofi to construct a vaccine-manufacturing plant in Shenzhen municipality.

Sanofi-Aventis to Build Vaccine Facility in China

Editors' Picks of Pharmaceutical Science & Technology Innovations

In the Spotlight November 2007

Market demand for cytotoxic drugs is leading CMOs to expand their API manufacturing and formulation services.