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Pharmaceutical Technology-04-02-2019
Pharmaceutical Technology
Cleaning Chromatography Resin Residues from Surfaces
April 02, 2019
Features
43
4
Laboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.
OSD Continuous Manufacturing Strategies
April 02, 2019
Features
43
4
In OSD continuous manufacturing, flexible batch sizes can optimize supply, but equipment and processing challenges are still being addressed.
Channeling Customer Complaints into Quality
April 02, 2019
Ask the Expert
43
4
A robust customer complaint handling system is an integral part of a quality management system, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
Continuous Manufacturing Gains Major Push from FDA
April 02, 2019
Regulatory Watch
43
4
FDA is moving to shift industry away from step-wise batch production.
Particles on Best Behavior
April 02, 2019
Features
43
4
Characterizing particles and understanding bulk powder behavior is critical to get the best pharma product.
Spray Drying: Supporting Patient-Centric Drug Development
April 02, 2019
Cover Story
43
4
Pharmaceutical Technology Europe spoke with Manuel Leal, business development director for Idifarma to learn more about spray drying and how it can support patient-centric drug development.
Advanced Cell Penetrating Peptide Systems for Gene Therapy
April 02, 2019
Features
43
4
Intracellular strategies offer an effective alternative approach to deliver a range of therapeutic proteins.
Degradation Pathways: A Case Study with Pegylated L-Asparaginase
April 02, 2019
Peer-Reviewed Research
43
4
It is important to address manufacturing problems associated with the shorter shelf-life of pegylated L-asparaginase (pegaspargase) upon long-term storage in the form of a solution.
Select Suppliers with Demonstrated Expertise to Avoid Sourcing “Bad” APIs
April 02, 2019
API Synthesis and Manufacturing
43
4
Confidence in the quality systems and scientific competence of the API manufacturing team is essential.
Locking Fraudulent Materials Out of the Supply Chain
April 02, 2019
Features
43
4
Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.
Designing for Patient and Public Health
April 02, 2019
From the Editor
43
4
Better drug design and patient education may promote improved personal and public health.
Patient‑Centric Drug Development Comes of Age
April 02, 2019
Cover Story
43
4
Easier access to information, targeting smaller patient populations, and increased regulatory focus on patient outcomes are driving patient‑centric drug development.
Successful Technology Transfer
April 02, 2019
Features
43
4
Pharmaceutical Technology spoke with Roger Croucher, senior manager, R&D projects, at Catalent Pharma Solutions; Daniel M. Bowles, senior director, chemical development, at Cambrex; and Kurt J Kiewel, director, new product development and analytical services, also at Cambrex about best practices for a successful technology transfer.
Technology Transfer: Best Practices in Operational Development
April 02, 2019
Features
43
4
Successful technology transfer depends on the ability to anticipate risks and plan ahead.
Digitizing to Modernize Manufacturing
April 02, 2019
Features
43
4
Moving from paper-based to digitalized processes is the first step to enabling quality management and manufacturing to work in sync.
High Shear Planetary Dispersers
April 02, 2019
Product Spotlight
43
4
The Ross PowerMix is a hybrid planetary mixer suited to address the need for high shear in formulations too viscous for conventional dual-shaft mixers.
Multichannel Pipettes for 384-Well Plates
April 02, 2019
Product Spotlight
43
4
Eppendorf’s 16- and 24-channel pipettes can handle entire columns and rows of a 384-well plate in one step.
Polystyrene for FTIR, MidIR, and NIR Wavelength Calibration
April 02, 2019
Product Spotlight
43
4
Starna supplies polystyrene film references for use in the mid-infrared (MidIR) and near-infrared (NIR) with full traceability to National Institute of Standards and Technology.
New MALS Detector
April 02, 2019
Product Spotlight
43
4
Tosoh Bioscience’s LenS3 Multi-Angle Light Scattering (MALS) detector offers a new approach for measuring molecular weight (MW) and radius of gyration (Rg) of synthetic polymers, polysaccharides, proteins, and biopolymers.
Pharmaceutical Technology North America, April 2019 (PDF)
April 02, 2019
Issue PDF
43
4
Click the title above to open the Pharmaceutical Technology April 2019 issue in an interactive PDF format.
Pulling Together to Advance Patient-Focused Drug Products
April 02, 2019
Cover Story
43
4
More work needed to advance drug design and development effectively.
Regulating Pharmaceuticals in the Environment
April 01, 2019
Regulatory Watch
43
4
The European Commission has published a strategy that will form the basis for the European Union’s policy on pharmaceuticals in the environment.
Doing the Brexit Hokey Cokey
April 01, 2019
From the Editor
43
4
Uncertainty remains around the UK’s departure from the EU, potentially causing irreparable damage to the bio/pharma sector.