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antibody dependent cellular cytotoxicity (ADCC) and can exert potent cytotoxic effects even when their target antigen is low. In addition, they work in whole blood and retain all other desirable features of common antibodies.
“The GS System and the CHOK1SV Cell Line continue to be a gold standard for therapeutic antibody development. We are proud to be able to support Pfizer with this technology for their ongoing development portfolio,” said Karen Fallen, VP Head of Licensing, Lonza Custom Development Services.
Pharmalucence Announces Manufacturing Contract at its New Parenteral Manufacturing Facility in Billerica, MA
Pharmalucence, Inc. announced that it has entered into an agreement with Lantheus Medical Imaging, Inc. to serve as a contract manufacturer of DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension for contrast-enhanced echocardiography. The contract secures manufacturing capacity for Lantheus at the newly constructed Pharmalucence drug production facility in Billerica, MA for a minimum of 10 years.
Ed Connolly, Pharmalucence Chief Operating Officer, stated, “Pharmalucence has established a world-class manufacturing facility here in New England, which has been recognized by companies who choose to outsource their manufacturing. We are extremely pleased to partner with Lantheus, a local company with a reputation for exceptional product innovation and quality, for the supply of DEFINITY®.”
“Our manufacturing agreement with Pharmalucence is a vital component of our plan to secure long-term supply of DEFINITY®,” said Jeff Bailey, Lantheus President and Chief Executive Officer. “We look forward to working with Pharmalucence, who has a shared commitment to deliver the highest quality products to the customers and patients who benefit from DEFINITY®.”
American Association of Pharmaceutical Scientists Launches Foundation
The American Association of Pharmaceutical Scientists (AAPS) has established a premier information network for pharmaceutical scientists around the world. In order to have a greater impact in advancing the contributions of the pharmaceutical sciences to global health, AAPS is proud to announce the launch of the AAPS Foundation.
The AAPS Foundation is dedicated to the support of scientists and initiatives that promote the discovery, development, and manufacture of drugs by attracting and providing resources used
to advance research, education, and training. The foundation seeks to empower pharmaceutical scientists, and to expand and engage the interests of future generations of scientists, in a manner that positively impacts the pharmaceutical sciences and creates solutions addressing vital needs found in the treatment of disease and the preservation of health.
“It is more important now than ever that pharmaceutical scientists develop skills that will meet the world’s evolving health challenges; but these needs and personal development gaps cannot be addressed without dynamic and up-to-date initiatives,” stated Philip R. Mayer, Ph.D., chair of the AAPS Foundation Executive Committee. “Support of the AAPS Foundation can help ensure that current and future pharmaceutical scientists are fully prepared to meet the challenges found in the discovery and development of today’s modern medicines.”
Hovione: New Inhalation Capsule Filling Machine Fills Market Gap
Hovione announced today the expansion of its inhalation drug product development services with the introduction of a high precision MG2 FlexaLAB capsule filling machine.
This investment is in response to market demand for high-precision, capsule filling services for inhaled products and is the last step in Hovione’s plan to offer development services in all quadrants of inhalation projects: from API to formulation to powder inhalers to final unit dose.
This investment intends to support Phase II-Phase III clinical trials to Hovione’s business partners. “We give our customers an edge in inhalation capsule filling for drug delivery to the lung, by providing access to a machine capable of very high precision filling of low doses, down to 5 mg. We are perhaps the only independent company with expertise in every aspect of the inhaled drug development process and this acquisition strengthens our commitment to inhalation drug development”, said Peter Villax, Vice-President. Hovione is currently executing inhaled drug development projects for a number of pharmaceutical companies, involving API process development, particle engineering, formulation development and clinical supplies.
Capable of filling up to 3,000 capsules/hour, the FlexaLAB is the first MG2 equipment fitted with the MultiNET system, which allows 100% net weight unit verification for increased precision and suitable internal process controls for supporting inhalation development activities.
Gonçalo Andrade, Business Development Manager, said: “The acquisition of the MG2 FlexaLAB unit allows Hovione to support capsule filling activities in all stages of clinical development and even low volume commercial manufacturing of inhalation drug products. Customers can now partner with Hovione for a full service inhalation drug development manufacturing, all under one roof.”
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