Pharmaceutical Technology April 2017

April 2017 | Volume 41, Issue 4
Pharmaceutical Technology April 2017 Issue
Cover Story
Design of experiment plays a crucial role in the optimization process of formulation development.
David Fulper, PhD, director of technology support at Catalent, shares insights on the challenges and opportunities for cannabis-based therapeutics.
Anil Kane, executive director, Global Head of Formulation Sciences, Pharmaceutical Development Services at Patheon discusses key parameters in the development and manufacturing of oral solid-dosage forms.
Peer-Reviewed Research
The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.
Features
The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
Renewable energy can improve energy efficiency and reduce carbon dioxide emissions in pharmaceutical manufacturing processes.
The process control and automation requirements of single-use systems differ from those of stainless-steel equipment.
Interpretation of calorimetric data is tricky. The author suggests 10 questions that should be asked of any calorimetric method, along with the rationales behind them.
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics
MDRS differentiates the API from the product matrix and enables measurement of particle size and shape.
As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.
API Synthesis and Manufacturing
Advances in process analytical technology have been achieved, but significant challenges remain.
Manufacturing
The transfer of fluids is governed by different equipment requirements across the medical, biopharma, and cell therapy manufacturing industries.
Regulatory Watch
Both the European Union and United States are still ironing out issues such as confidentiality of information and recognition of competence of each party’s regulatory authorities in their agreement on GMP inspections.
Industry fears limited benefits as FDA readies voluntary data tracking program.
Outsourcing Outlook
New study shows China biopharma companies face staffing shortages.
Ask the Expert
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the value of internal audits and how the information gained can be applied.
From The Editor
Philadelphia plays host to CPhI North America on May 16-18, 2017.
Product Spotlight
By Pharmaceutical Technology Editors
The VersaMix Multi-Shaft Mixer, from Ross, Charles & Son, is used to mix pastes, creams, and gel-type products.
By Pharmaceutical Technology Editors
The Thinky PR-1 Nanoparticle Dispersion Machine from Intertronics is a desktop unit that can disperse carbon nanotubes (CNT), graphene, and other 2D nanomaterials within a closed container.
By Pharmaceutical Technology Editors
The Cannabis Analyzer for Potency from Shimadzu Scientific Instruments (SSI) is a high-performance liquid chromatograph (HPLC) specifically for quantitative determination of cannabinoid content.
By Pharmaceutical Technology Editors
The X500B QTOF System is the latest solution in SCIEX’s X-Series Quadrupole Time of Flight (QTOF) mass spectrometry (MS) platform.
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