PCI, Inc. a contract manufacturing and research organization based in Newburyport, MA that develops and manufactures NCEs, generic APIs and fine chemicals has grown from a small start-up to a company that can now take a product all the way from development to commercial production in a smooth and seamless process for its clients.
When it comes to coating tablets there are musts that really count and then there are the other...
It seems simple enough . . . when planning a new laboratory facility, ensure that there is...
Today’s biopharmaceutical manufacturers face a wide range of challenges. The regulatory...
When developing a clean room program, it is important to make sure that the plan meets all regulatory requirements mandated by agencies such as the Institute of Environmental Sciences and Technology (IEST) and the International Organization for Standardization (ISO).
No two packaging projects are alike and in order to make it all work and to keep everything on track and everyone happy you need to have a flexible, responsive and quality-driven organizations. Reed-Lane has deftly combined these qualities along with recent investments to create a truly flexible contract packaging operation.
How important are intuitive, durable and clean controls for equipment used in your business? As a practical matter, controls that require operators to actually touch them, wearing gloves or not, can never be really clean, however many protocols or chemicals are employed.
High-Performance Exosome Purification and Characterization via Density Gradient Ultracentrifugation and Dynamic Light ScatteringMarch 12, 2014 2:06 pm | Comments
Exosomes purification and analyses comprise a fast evolving research area; more than 70% of published research on exosomes has been done within the last six years. Challenges to researchers working with exosomes include setting up density gradients by hand, because it is tedious, time-consuming and subject to user, lab, and method variability.
Personalized Testing - BioReliance Builds a Biologics Clearance Service Facility That’s a Home Away from HomeMarch 11, 2014 4:09 pm | by Mike Auerbach, Editor in Chief @PharmProEditor | Comments
BioReliance, a company that provides testing and manufacturing services to pharmaceutical/biopharma companies, realized that the absence of full featured and customizable biological clearance testing facilities was an opportunity. The company’s recently opened facility in Rockville, MD offers their clients private and secure work lounges along with fully modular lab spaces that can be designed, equipped and ready-to-go upon their arrival.
The movement toward transparency is global, touching almost every aspect of society. Whether the topic is NSA eavesdropping in the U.S. or banking practices in the European Union, transparency and accountability go hand in hand. The pharma industry is no different.
The right combination of equipment, capsule, and formulation can bolster yields, speed up filling, and cut downtime for faster market delivery and higher profits.
The Norwich Pharma Services manufacturing facility in Norwich, New York is as varied in its capabilities as it is its equipment investment strategy. This dedication to growth through equipment and technology investment has led to it being recognized as one of Pharmaceutical Processing’s Facility Excellence Award winners for 2014.
Custom Processing Services has a strong track record of contract manufacturing in the pharmaceuticals marketplace. And on November 11, 2011 that legacy was strengthened with the opening of a 42,000 square foot facility dedicated to GMP processing, with two unique GMP processing stations. This commitment has led to it being recognized as one of Pharmaceutical Processing’s Facility Excellence Award winners for 2014.
The Caliber Biotherapeutics manufacturing facility in Bryan, Texas offers an interesting look at the development and integration of Plant Made Pharmaceuticals. This commitment to new and innovative drug development strategies has led to it being recognized as one of Pharmaceutical Processing’s Facility Excellence Award winners for 2014.
New development technologies, expanded contract manufacturing and service capabilities, as well as innovative equipment investment strategies highlight leading practices from the best in pharmaceutical processing comprise the 2014 Pharmaceutical Processing Facility Excellence Award winners.
In the biotechnology and pharmaceutical processing industries, maintaining diaphragm valves is considered the primary bottleneck of the maintenance process. A typical diaphragm change-out can easily take a full week of plant downtime, resulting in significant hours of lost production time.
GNC, the largest specialty retailer of nutritional supplements in the world, is respected for its focus on quality. They rely on their subsidiary, Nutra Manufacturing, to apply their “quality first” principle to manufacturing. Over the years, Nutra has turned to Symetix® for high performance optical inspection systems that verify product quality.
The use of disposables in biopharmaceutical production facilities started in the late 1990’s and has evolved to include innovative Single-Use Systems (SUS) products from upstream bioreactors/clarification filtration to downstream separation and purification applications, TFF, membrane chromatography, and virus removal.
Barrier isolator technology is one area of pharmaceutical manufacturing where the latest and greatest technology is becoming a driver of business necessity.