Dosage Forms

The main challenge for tablet manufacturers processing highly potent APIs (HPAPIs) is to protect equipment operators from the inhalation of airborne particles and prevent skin contact with the product during the entire production process: dispensing, granulation, tablet compression, coating and packaging.

Representatives from Pfizer R&D, DEM Solutions, Colorcon, and ARmark Authentication Technologies provide insight into recent tablet-coating technologies.

Pharmaceutical Technology Europe brings together suppliers of tabletting equipment and excipients to discuss the challenges, innovations and latest trends in the tabletting industry.

The global market for biosimilars is set to grow from $243 million in 2010 to $3.7 billion in 2015, according to research from Datamonitor, an independent industry analyst company.

Novartis has completed the acquisition of a majority stake in Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. — one of the largest privately held vaccines companies in China.

Novartis acquired a majority stake in Zhejiang Tianyuan Bio-Pharmaceutical, one of the largest privately held vaccine companies in China. The acquisition gives Novartis an expanded presence in the Chinese vaccine market and will facilitate the introduction of Novartis's vaccines into the country.

Japan has suspended the use of two pediatric vaccines made by Pfizer and sanofi following the deaths of four children in three days.

Although tablet manufacture is traditionally a batchbased wet granulation process, there are many advantages to be gained by adopting dry granulation, including lower costs and increased yields.

Tooling standardisation in the tablet manufacturing industry is a topic that has concerned tabletting professionals for decades.

With a regulatory pathway for follow-on biologics, industry is wondering what FDA will do next.

The authors evaluated the manufacturing data of 40-mg tablets of furosemide, a potent diuretic.

A single, global tooling standard would offer many benefits, but one has been slow to emerge.

The author provides an overview of QbD implmentation for biopharmaceuticals.

The authors outline the key decision points FDA must consider in putting forth a US regulatory pathway for biosimilars.

HHS Releases a New National Vaccine Plan

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the February 2011 edition from Alfa Laval and GE Healthcare.

The application of the first piston syringes to treat medical complications was described in Roman times during the 1st century, and forms of intravenous injection and infusion began as early as 1670.

Deep process characterization and "lab-on-a-chip" enable SMART bioprocess design.

FDA issued a draft guidance for industry on Jan. 18, 2011, about the size of beads within drug products labeled for sprinkle.

A company's contamination-control plan is an important document designed to formalize the rationale, methods, and validation of contamination-control procedures in a manufacturing facility. The author describes the role of bioburden in the contamination-control plan.

Improvements in analytical techniques may call for a re-evaluation of the biopharmaceutical industry saying that "the process is the product."

Dishman is giving a step further in its strategy to manufacture high potency (HiPo) Active Pharmaceutical Ingredients (APIs).

Biopharmaceuticals commonly cannot be terminally sterilised, as such aseptic processing using sterilising grade filtration is essential.

World AIDS Day 2010 reminds us that prevention and hope can help fight the disease.

EMA Publishes New Transparency Policy, Releases Guideline for Biosimilar mAbs.

The growing uptake of single-use sterile packaging in pharmaceutical production processes mirrors the broader trend towards single-use across every sector of the pharmaceutical industry.

A European-wide awareness initiative hopes to tackle the issue of antibiotic over-prescription, but industry must also be encouraged to make further investments.

FDA Holds Biosimilars Public Hearing

Industrial and academic partnerships forge new territory in solid-state chemistry.

Today begins the two-day public hearing being held at FDA headquarters in Rockville, MD, to gain public in put on how to implement and regulate the follow-on biologics pathway that was cleared via President Obama's Biologics Price Competition and Innovation Act of 2009, which falls under the 2010 approved healthcare reform legislation.