			Contract manufacturing is a booming business, especially considering that many pharmaceutical companies-including those with a focus on biologic products-			are no longer conducting much of their own research and development in-house. Fewer still are capable of scaling up from laboratory to commercial production without some type of outside help from a contract manufacturing organization (CMO). 			 			Read this article and other articles in 

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Fluctuating Capacity and Demand Conditions in Biomanufacturing

	Many pharmaceutical companies have adopted the permitted daily exposure (PDE), or acceptable daily exposure (ADE), to set cleaning validation limits. Some regulatory agencies now require its use, but some companies continue to argue against it, particularly biologics manufacturers. Critics of the approach argue that protein molecules are denatured or degraded by their cleaning processes, and that alternate approaches should be used.	 	Read this article and other articles in 

Can alternative approaches to the permitted/acceptable daily exposure be justified?

Cleaning Validation for Biologics

	Single-use technologies including polymer film bags, tubing, filter capsules, and appropriate connectors have become widely accepted in bioprocessing of proteins and vaccines. Recognized key benefits are elimination of cross contamination and cleaning, reduction of capital cost and environmental impact, and greater flexibility in manufacturing.	 	Read this article and other articles in 

BioPharm International eBooksVolume 28, Issue 14 Single-use technologies including polymer film bags, tubing, filter capsules, and appropriate connectors have become widely accepted in bioprocessing of proteins and vaccines.

Automation of Single-Use Systems

	Manufacturing advanced biologics demands solutions that are quite different from what is being used for large-scale industrial biologics processing today. This article touches on approaches that work with advanced biologics.	 	Read this article and other articles in 

Isolators offer a safety and economic advantage for next-generation regenerative medicine products.

Aseptic Processing for Cytotherapy, Regenerative Medicine, and Tissue-Engineered Products

	Post-grant review of patents at the Patent Trial and Appeal Board (PTAB) has taken the intellectual property (IP) world by storm. Post-grant reviews allow anyone to challenge the validity of a patent far more quickly and cheaply than has ever before been possible. They have replaced the huge financial drain and business risk of traditional patent litigation with a rapid adjudication system that delivers certainty for a price comparable to a patent license fee. 	 	Read this article and other articles in 

This article examines trends in biopharma post-grant patent review and projects what the future holds in store.

Are Biopharma Patents Poised on the Post-Grant Chopping Block?

	Assessing a drug candidate’s suitability during preformulation is essential to minimize the risk of costly downstream failure. Stability is a defining feature of biotherapeutic performance; measuring formulation stability during early-phase screening allows developers to make robust predictions of suitability for further development. 	 	Read this article and other articles in 

This article introduces the technology that powers automated HT–DLS and explores its practical applications in enhancing formulation stability investigations.

Innovations in Automation—High-Throughput Dynamic Light Scattering for Screening Biotherapeutic Formulations

	Training remains one of the most effective ways to build up the skills of employees within any organization. When it comes to training in the pharmaceutical industry, however, practices are a bit less robust and results can be more variable and disappointing. 	 	Read this article and other articles in 

How can the industry achieve excellence when its training programs are geared to meeting minimum regulatory guidelines?