Manufacturing

Strategies to minimise particle levels in the finished product when using single-use technologies downstream of final filters.

A perspective from Pfizer on the lessons from small-molecule manufacturing that can be applied to biomanufacturing.

To further enhance its position in clinical-trial materials supply, Catalent Pharma Solutions has agreed to acquire the clinical-trial supplies business of Aptuit for $410 million on a cash and debt-fee basis.

Last week, Ben Venue Laboratories decided to exit the contract-manufacturing business during the next several years, thus ending more than 70 years of service in this field. To ensure the supply of medically necessary products, the company will work with its customers to develop and execute long-term transition plans.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the August 2011 edition from Chemineer and IDS.

We try to use previous experience to develop the optimal granulation process for each new ingredient, but we sometimes get it wrong. Many times, we?ve taken materials from the granulator only to find that they exhibit poor flow and insufficient density. How can we easily determine the end point of a given granulation process?

Achieving a consistent level of quality control could greatly reduce waste and save money for the pharmaceutical industry. But why has talk about Six Sigma died down at a time when it could be of great benefit?

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

The Society for Chemical Manufacturers & Affiliates commented on EPA's modifications to the Inventory Update Reporting rule, also broadly know as the Chemical Data Reporting rule. EPA issued the final rule earlier this month.

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.

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.

Merck & Co. announced last week that it plans to reduce its global workforce, as measured by year-end 2009 levels, by an additional 12–13% by 2015. The company made the announcement as part of its second-quarter earnings release, which the company issued on July 29, 2011.

Xavier University, in partnership with FDA, will hold a conference in October to focus on the changing regulatory, business, and operational issues affecting the global pharmaceutical supply chain.

The International Society for Pharmaceutical Engineering published a guidance document that defines current best practices in pharmaceutical manufacturing applications for handling gases that come into direct contact with the biopharmaceutical and pharmaceutical process steams.

Rising imports and overseas production spur realignment of enforcement.

The pharmaceutical majors continue rationalizing manufacturing capacity in established markets as they forge their manufacturing networks in biologics and emerging markets.

The authors present a method for controlling the release of therapeutics by applying a plasma polymer layer to the surface of porous materials.

Contract manufacturing organizations throughout Asia are increasing their capabilities to meet market demand and attract foreign investment and partnerships.

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

O-arylation and O-alkylation, a one-pot protein synthesis, a combined approach in continued and chemocatalysis, and green-chemistry applications are the target of some recent advances in API synthesis.

China rises to the top as a destination for international outsourcing.

A book about developing quality-control training manuals provides a wealth of information and a dearth of practical help.

New product reviews for August 2011 focusing on automation, process control, and information technology.

The second in a series of eight case studies from the Product Quality Research Institute focuses on functional equivalence for equipment.

Visiting a new site or going down memory lane may not get you where you want to go.