The May issue of Pharmaceutical Processing profiles PCI, a contract developer and manufacturer of custom NCEs, fine chemicals and generic APIs based in Newburyport, MA. We also take a look at the critical success factors clients evaluate when choosing a CMO. Our manufacturing services Q&A discusses current trends, issues and the future of pharmaceutical processing services. In addition we cover tablet coating, single-use technologies and QbD in test method development and validation.
The April issue of Pharmaceutical Processing profiles Reed-Lane, a contract packager of solid-...
Barrier isolator technology is one area of pharmaceutical manufacturing where the latest and...
High Shear Granulating: A look at advances in wet milling and controlled spraying in granulation operationsAugust 29, 2013 11:03 am | by Raja Krishnan and Michael Buzecky, Fluid Air, Inc. | Articles | Comments
High shear wet granulation is a cornerstone of the formulator’s and process engineer’s pharmaceutical manufacturing toolbox. It is used to increase the density and particle size of a composition to improve powder flow and compressibility on the tablet press when dry processing methods are insufficient to produce tablets or capsules with acceptable uniformity, hardness, and friability.
In the July/August 2013 issue of Pharmaceutical Processing we profile Impact Analytical's range of services for the pharmaceutical industry and its new facility in Midland, MI. Additional articles on contract services include a look at quality and reliability drivers for strategic outsourcing and a focus on packaging services. Our Special Report details how numerical simulations can be used to continuously process APIs. Other articles include a look at small parts handling, tablet manufacturing, pharmaceutical compliance and process validation.
Blister packaging is not rocket science – or is it? Good blisters are the result of an optimized interaction between materials, equipment/tooling, and processing conditions. Neglecting just one is inviting trouble. Paying attention to all three cornerstones of this magic triangle will keep your line operators, purchasing personnel and customers happy.
Current status and future prospects.
Under the watchful eyes of regulators, aseptic filling undergoes a makeover.
Laureate Biopharma’s history of excellence prepares them for the future.
The 2012 electio n was filled with tight races, close victories and upsets. Now that the votes are in, and the Obama Administration begins a second term in office, questions remain about the continued implementation of the Patient Protection and Affordable Care Act (ACA) and its impact on patient access.
As we move forward into 2013 the global pharmaceutical market can be best described as transitory.
Many compendial water systems, particularly purified water systems, have distribution systems with a biofilm. Detection, removal, and control of biofilm in compendial water systems are extremely important.
So far in 2012, the FDA has issued nearly 300 warning letters. More than half of those were sent to companies within the pharmaceutical, medical device and dietary supplement industries.
Mitigating risks in oral solid dosage manufacturing operations
CMOs say clients not communicating effectively - unrealistic timeframes also a common complaint
The lean way to design and build pharmaceutical facilities.
FDA regulations provide a cleaning and sterilization roadmap for manufacturers, but companies are provided with some flexibility when it comes to the specifics. Today, new developments are giving manufacturers a wider variety of options, ranging from safer facility-wide decontamination methods to new autoclave technologies.
Anteco Pharma registers big growth but retains its one-on-one approach.
Developing a biopharmaceutical is just like developing a traditional small molecule therapeutic…except it is not. While the types of data needed for regulatory filings is the same, the significantly increased size and molecular complexity of biopharmaceuticals compared to small molecule therapeutics has a significant impact on the strategies and activities required for development.
There is a significant movement within the biotech industry to evaluate and implement single-use (SU) manufacturing systems in order to improve manufacturing efficiency, flexibility, and reduce costs.i The focus of many industry conferences and technical meetings centers on expanding the industry’s body of knowledge around SU system design and applications.ii
Parenteral manufacturers face a host of challenges - many can be solved with a restricted access barrier system.
Preclinical contract research organizations are advancing to meet clients’ new needs.
OsoBio's capabilities make it hard to be beat in the injectables market
China. That huge potential market for pharmaceuticals is growing economically by leaps and bounds. Most international pharmaceutical companies want their own slice of that market - a market that is growing more affluent, spending more and is unfortunately seeing an increase in diseases associated with their new found affluence.
The journey from gene to clinic for a protein therapeutic is long and sometimes torturous, requiring a wide range of knowledge, expertise and capabilities. An industry-wide imperative to accelerate the journey with the same or fewer resources simply adds more pressure.
CMO's tailor-made services help simplify the validation process.
Automated solutions are increasing the efficiency of solid-dosage testing.
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