Process and Scaling

Careful attention to detail will help to prevent valuable assets from "melting" away.

An understanding of the pan-coating process based on first principles can support successful scale up.

Even the slightest of errors in exponential calculations can cause the biggest of headaches.

A technical forum featuring Tim Freeman of Freeman Technology and Carl Levoguer of Malvern Instruments.

It's better to catch costly mistakes in the laboratory before they reach the accounting department.

Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.

There are various theories about how to scale up a solid dosage coating operation in a pan coater. This article provides a basic process understanding and scale-up theory based on first principles.

Critical issues that should be considered when scaling up a hot-melt extrusion process.

Failure to disclose info may work sometimes, but eventually every question will be answered.

In a world where product recalls can mean the end of a company, all batches must be perfect.

With the increasing use of hot-melt extrusion, extruder manufacturers have developed mid-size twin-screw extruders that facilitate process development and scale-up to commercial processes.

A nickel's worth of free advice to the competition could come at the expense of your bottom line.

Technology may expedite operations, but the absence of the human element could cost dearly.

Cleanliness is crucial, even if zapping and trapping is necessary to reduce product contamination.

On Sept. 27, 2011, FDA sent Genentech a Form 483 listing several violations at the company's South San Francisco, California, plant. The violations included problems with investigations into batch failures, inappropriate equipment design, and insufficient protection against contamination. FDA visited the plant, which produces the cancer drug Avastin, 13 times in September 2011 and made four observations.

Careful mixing during a product's distillation can help avert trouble from a strong concoction.

June and July saw three major US conferences on implementing single-use technologies: the IBC Single-use Applications meeting, the PDA Single-use Workshop and the Bio-Process Systems Alliance (BPSA) International Single-use Summit (ISUS). Jerold Martin highlights some of the key topics discussed at these meetings.

When I run a small production batch of a particular formulation with the same tablet press used to develop it, I get compressibility and disintegration issues. What am I doing wrong?

Letting contamination build up can cause multiple headaches.

Being aware of a forthcoming inspection or how a product was made can make a huge difference.

Directors from FDA's Center for Drug Evaluation and Research summarize findings in an FDA-commissioned report on QbD and propose actions the agency can take to encourage full-scale QbD implementation.

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.

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

Quality management requires more effort in a complex supply chain.

Pfizer's Experience with QbD. This article is part of a special issue on Outsourcing.

The authors share their approach and experience working in complex, multicompany environments for in-licensed products to develop successful chemistry, manufacturing, and controls packages for managing outsourcing partnerships.

An Industry Roundtable Moderated by Patricia Van Arnum and Rich Whitworh. Contract service and technology providers share their perspectives on the influence of quality by design in the expectations between sponsor companies and outsourcing providers.

The same recipe obtained in laboratory-scale equipment cannot, without modifications, generally be used to freeze-dry the product in a pilot-scale or industrial-scale freeze-dryer.

Getting an answer is easy-asking the right question is apparently more difficult.

Sometimes, there are just too many cooks in the kitchen.