EXECUTIVE INTERVIEW – Norwich Pharma Services: Synchronized Outsourced Solutions for Contract Development & Manufacturing
Drug Development Executive: Kristin Arnold, PhD, Norwich’s VP of Product Development and Technical Services, talks about the company’s long history in pharmaceutical manufacturing, its evolution as a CDMO, the “perfect” client, and its role as a service provider from start to finish.
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Early-Stage Partnerships Are On The Rise
Contributor Cindy H. Dubin asked leading CMOs and CDMOs to describe the value-added services they offer with respect to formulation and manufacturing. Solving challenges of insufficient solubility, poor stability, identifying excipient candidates, and particle design topped their list of offerings.
DISPOSABLE TECHNOLOGY – Use of Disposable Technology in Clinical Fill & Finish Manufacturing: Benefits & Considerations
Claudia Roth, PhD, reviews not only the benefits of using disposables, but the real-world variables to consider when converting to single-use technology. The pathway begins with the question, why use disposables?
Sam de Costa, PhD, believes the launch of two stabilization and drug delivery platforms that have the potential to revolutionize the delivery of vaccines, therapeutics, and diagnostics, while significantly cutting costs, has attracted sharp interest from pharmaceutical and biotech companies around the world.
EXECUTIVE INTERVIEW – Hermes Pharma: User-Friendly Dosage Forms, a Win-Win Situation for Patients & Pharma
Drug Development Executive: Dr. Thomas Hein, Director, Sales & Business Development at Hermes Pharma, discusses how user-friendly dosage forms help put patients first, their advantages for patients and pharmaceutical companies, as well as the challenges associated with their development and production.
Contributor Cindy H. Dubin talks with some of the leading experts in the industry about the importance of outsourcing analytical testing in the biologic/biosimilar space, the associated challenges, and how to ensure products get to market safely and quickly.
Drug Development Executive: Andreas Schütte, Member of the Management Board, Plastics & Devices Division, discusses his important role in Gerresheimer’s divisional restructuring process, and how he is convinced the new structure better reflects customer requirements.
In January, the FDA banned imports from a fourth Ranbaxy plant in India after an unscheduled inspection revealed a lab littered with flies, a leaking…
RESIDUAL IMPURITIES – Developing & Validating an Efficient Method to Determine Residuals of Hormone Products by LC-MS After Cleaning of Equipment
Geoff Carr, PhD, describes the benefits of LC-MS and presents an effective method using this technology to determine the potential residual amount of eight active ingredients used in oral contraceptive tablets after cleaning equipment used in their manufacture.
Thomas Otto believes a specialized CDMO can provide efficient solutions to the many challenges surrounding lyophilized substances. But it should be ascertained they have packaging, manufacturing, and lyophilization expertise.
EXCLUSIVE ONLINE CONTENT
PHASTAR recently announced today it has entered into a technology partnership with Medidata Solutions, Inc. PHASTAR will deploy several solutions from the Medidata Rave Clinical Cloud, including Rave EDC, Coder, eCOA, and RTSM.
iBio, Inc. recently announced the activation of its new cGMP sterile fill-finish services operation via the signing of a supply agreement with a clinical-stage biopharmaceutical company developing breakthrough gene and cell therapies.
As the pipeline of biologic drugs intended to treat complex disease expands, the typical timeline for drug development seems to be shortening more frequently and with more intensity……..
AptarGroup, Inc. recently announced it has acquired two leading pharmaceutical services companies, Nanopharm Ltd. and Gateway Analytical LLC, for a combined enterprise value of approximately $50 million.
PCI Pharma Services Announces Further Expansion to Maintain Industry-Leading Quality, Service, and Flexibility
PCI Pharma Services, a leading biopharmaceutical outsourcing services provider, recently announced the growth of its West Coast Clinical operations with expansion into its third facility in San Diego.