Pharmaceutical Technology-04-02-2019

Laboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.

In OSD continuous manufacturing, flexible batch sizes can optimize supply, but equipment and processing challenges are still being addressed.

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.

FDA is moving to shift industry away from step-wise batch production.

Characterizing particles and understanding bulk powder behavior is critical to get the best pharma product.

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.

Intracellular strategies offer an effective alternative approach to deliver a range of therapeutic proteins.

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.

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.

Better drug design and patient education may promote improved personal and public health.

Easier access to information, targeting smaller patient populations, and increased regulatory focus on patient outcomes are driving patient‑centric drug development.

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.

Successful technology transfer depends on the ability to anticipate risks and plan ahead.

Moving from paper-based to digitalized processes is the first step to enabling quality management and manufacturing to work in sync.

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.

Eppendorf’s 16- and 24-channel pipettes can handle entire columns and rows of a 384-well plate in one step.

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.

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.

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More work needed to advance drug design and development effectively.

The European Commission has published a strategy that will form the basis for the European Union’s policy on pharmaceuticals in the environment.

Uncertainty remains around the UK’s departure from the EU, potentially causing irreparable damage to the bio/pharma sector.