Kevin James and Shalini S. Dewan of BCC Research believe eliminating the risk of contamination is the greatest challenge faced by manufacturers of biopharmaceuticals, and currently, this requires high-level monitoring of critical manufacturing processes. Single-use technology aids biopharmaceutical manufacturers in overcoming this challenge by reducing or eliminating the need for sterilization between batches, thereby improving operational efficiency.
EXECUTIVE INTERVIEW – Unither Pharmaceuticals: Premeasured Dosage Forms to Improve Medication Adherence
Eric Goupil, CEO Unither Pharmaceuticals, speaks frankly about medication adherence, Unither’s technology, and some of the challenges that they face today.
Divyaa Ravishankar, MS, indicates LOC-based devices are an integration of multiple disciplines and the miniaturization of the major laboratory procedures. Recently, these devices are branching into additional aspects of healthcare, such as drug delivery, stem cell, environmental monitoring, and synthetic biology.
Degenhard Marx, PhD, and Matthias Birkhoff, discuss how the use of preservatives in eye drops is still controversial, but more and more evidence supports the use of unpreserved eye drops for treatment of chronic diseases.
EXECUTIVE INTERVIEW – Vetter: Helping Small Biotech Companies Execute a Successful Drug Development Process
Dr. Susanne Resatz, President of Vetter Development Services USA, Inc., discusses the many benefits to small biotech companies in utilizing a full-service CDMO, and what advanced services the Chicago-based facility offers its growing customer base.
David Enloe, Althea’s President and CEO, discusses his company’s business strategy, why companies choose Althea, trends in the CMO industry, and how the company is growing since the acquisition of Ajinomoto.
SPRAY-DRIED DISPERSIONS – Developing Process Control Strategies for the Manufacture of Spray-Dried Dispersions
Devon DuBose, Dana Settell, Nathan Bennette, and Amber Broadbent, PhD, say drug pipelines increasingly feature new drug candidates that exhibit poor solubility and require well-established enabling technologies to address this critical issue.
Stephen Turner believes a next-generation capability is now available to rapidly and comprehensively provide molecular profiles of normal and AD-affected brain cells and tissues, offering the possibility of new, AD stage-specific biomarkers and points of therapeutic intervention for developing new treatments.
Tom Johnson says by improving the collaborative experience without sacrificing control or security of sensitive information or intellectual property, identity hubs and their providers help pharmaceutical companies minimize the time and cost of clinical trials and the drug R&D process as a whole.
PLASMA-DERIVED BIOLOGICS – New Fractionation Process to Expand Availability of Plasma-Derived Treatments
Jeffrey B. Davis, MBA, explains how his company has initiated a three-phase process of scaling up the Salt Diafiltration Process, validating it for required FDA filings, and ultimately running the process at production scale to enable the clinical trial product to be produced.
EXCLUSIVE ONLINE CONTENT
STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – and Dizal Pharmaceutical, a biotechnology company, recently announced a strategic partnership.
Catalent (Booth 3101) recently announced it will launch its new OneBio Suite for the integrated development, manufacturing, and clinical supply of biologic drugs at the…
QPS, a global contract research organization (CRO) providing discovery, preclinical, and clinical drug development services, recently announced its successful implementation of ClinSpark, an eSource technology platform for Phase I automation, to support double-digit growth in Phase I clinical trials.
Cambrex Corporation, the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, recently announced that it had opened a new 120m2 quality control (QC) laboratory at its site in Paullo, Milan, Italy.
Ajinomoto Bio-Pharma Services, a leading provider of biopharmaceutical contract development and manufacturing services, recently announced that GeneDesign, Inc. has joined the global organization.