New pharmaceutical interface for Parsum in-line particle sizing probe from Malvern Instruments

The new ‘Pharma option 3: Parsum View’ user interface for the Parsum IPP 70 in-line particle size measurement probe, available from Malvern Instruments, simplifies the system’s use as a PAT (Process Analytical Technology) tool for continuous monitoring of granulation, spray drying and fluidised bed operations, for example. Parsum View is designed specifically to fulfil GMP requirements for pharmaceutical production. It can be supplied alone or in combination with pharma option 1- verification kit for checking measurement accuracy, and 2- material traceability, a unit with highly polished contact surfaces supplied with material traceability documentation.

Together with pharma options 1 and 2, Parsum View simplifies regulatory compliance, streamlining adoption and ongoing use of the IPP 70 within the pharmaceutical sector. It works either in a network (Ethernet) or on a standalone basis to provide the data security and complete audit trail necessary to meet the industry’s need for exemplary record keeping. Key features of the new release include: detailed user access control with flexible user levels; user and password management; and safe storage for measurement values and settings in an SQL-database

New article describes PAT for automated pharma mill control

A newly published article, jointly authored by specialists from Malvern Instruments and a major pharmaceutical company, describes the implementation of a Malvern Insitec on-line particle size analyzer on an active pharmaceutical ingredient milling operation at a commercial site. The Insitec was used to transform a stand-alone manual mill into an automated process unit that will integrate into the manufacturing facility. Automation benefits include improved product quality, increased throughput and less waste, and the authors state that this proven solution also opens the route to semi-continuous operation and real-time release, both of which are important long-term goals for operational excellence.
 

Unlike some process analytical technology (PAT) instruments that are modifications of laboratory solutions, the Insitec laser diffraction particle size analyzer was designed specifically for use in the process environment and is proving valuable for milling operations such as this

Malvern\'s light scattering supports formulation development for Novozymes\' recombinant albumins

29 November 2011, Malvern, UK: Scientists from Malvern Instruments and from biological ingredients and technology developers, Novozymes Biopharma, have successfully completed the first phase of extensive collaborative studies. These have involved the application of Malvern's light scattering technologies in evaluating the formulation stability of two of Novozymes leading recombinant albumin products - Albucult and Recombumin - which are used in the manufacture of human therapeutics.

Introducing a new, unique turnkey isolated milling suite at Interphex

0 January 2012: The results of a unique collaboration between four market leading companies serving the powder processing industries will be unveiled on Booth #2443 at Interphex 2012 (1-3 May; New York, USA). This new turnkey isolated milling suite encloses the innovative ARTMiS Automated RealTime Milling System within Powder Systems Ltd's (PSL) containment unit, providing a secure, advanced processing solution for those dealing with highly potent and/or high value materials

This small footprint instrument delivers precise high-resolution wet and dry sample measurement from 10 nm to 3.5 mm, with rapid operator-independent measurement enabling increased lab productivity

Smarter particle sizing’ on Malvern booth at Pittcon 2012

6 February 2012: Malvern, UK: Materials characterization company Malvern Instruments focuses on ‘smarter particle sizing’ as the Mastersizer 3000 laser diffraction particle size analyzer makes its Pittcon debut in 2012 (Booth #3641 Pittcon 2012, 11-15 Mar 2012, Orlando, FL).

This small footprint instrument delivers precise high-resolution wet and dry sample measurement from 10 nm to 3.5 mm, with rapid operator-independent measurement enabling increased lab productivity

Malvern Instruments commits to extensive program of free educational webinars in 2012

1 March 2012: Malvern, UK: With more than 70 English language webinars scheduled for 2012, plus many presented in multiple languages, Malvern Instruments continues its commitment to the company's firmly established cultural premise that knowledge sharing has great benefits for all concerned. Now in its 11th year, Malvern's program of online web seminars includes a wide range of material characterization presentations, appropriate for beginners through to experts from a wide range of industries. Catering to worldwide audiences, live presentations are broadcast across multiple time zones and extend across numerous languages including: English, Spanish, Portuguese, Chinese, Japanese, French and German. Participation is free of charge and registration is straightforward. Simply visit: www.malvern.com/webseminars

Malvern Instruments and Postnova Analytics co-operate to deliver combined solution for characterizing challenging particulate systems

15 February 2012: Malvern, UK: Malvern Instruments (Malvern, UK) and Postnova Analytics (Landsberg/Lech, Germany) have announced that they are co-operating to deliver the combined FFF (Field-Flow Fractionation) and DLS (Dynamic Light Scattering) solutions that today provide critical insight when characterizing a number of challenging particulate systems. Such systems include complex, aggregated, surface-coated and heterogeneous particles, as well as larger polymers, and aggregated, cross-linked, nano-particles and fibrillated proteins.

Georgia Tech researchers apply Malvern Zetasizer Nano in novel way to predict protein aggregation

4 January 2012: Malvern, UK: Researchers at the Georgia Institute of Technology School of Chemical & Biomolecular Engineering (Georgia, US) are using the simple to use technique of dynamic light scattering (DLS) measurements to predict otherwise difficult-to-measure aggregation behaviors in proteins. Using the Zetasizer Nano from Malvern Instruments, the Georgia Tech team measures small volumes of stable protein solutions with low concentrations of different salts. From the results they can infer ion-specific trends in the kinetics of aggregation induced by much higher concentrations of the same salts. Such trends, derived from the analysis of non-aggregating samples, could be confirmed experimentally in rapidly aggregating samples of the same protein.

Malvern specialist presents GPC/SEC benefits at Chromatographic Society meeting

28 February 2012: Malvern, UK: A separation technique specialist from Malvern Instruments will speak at the upcoming symposium ‘Chromatographic characterisation and purification techniques for Biopharm’, a meeting with a packed programme of presentations and workshops that will focus on monoclonal antibody-derived drugs. This 2-day event is organised by the Chromatographic Society and will be hosted at the GlaxoSmithKline Medicines Research Centre in Stevenage, UK on 14/15 March 2012. Malvern is also one of the symposium sponsors.

Malvern Instruments announces global agreement with Proveris Scientific

21 May 2013: Malvern, UK:
Malvern Instruments, a leader in the field of pharmaceutical material characterization, has announced a global agreement with Proveris Scientific Corporation, a company with complementary technology for orally inhaled and nasal drug product (OINDP) testing, to provide a complete solution for nasal spray characterization. This solution comprises the SoloTM for Spraytec system (Proveris), a high performance patented automated actuator and software for the precise control of the actuation profile applied during device testing, and the Spraytec laser diffraction particle size analyzer (Malvern), which measures the evolution of particle size in real-time during a spray event. In combination these technologies support the efficient optimization of nasal spray devices and formulations, and enable robust investigation of the parameters which may impact drug delivery.

Kingston University researchers acknowledge Malvern GPC contribution to new polymer research paper

25 May 2013: Malvern, UK: In a new paper published in Polymers & Polymer Composites (Vol 21, No 1, 2013), researchers at Kingston University in the UK report the results of continuing work to examine the effects of gamma irradiation on intraocular lenses (IOLs) used in cataract surgery. Triple detection gel permeation chromatography (GPC) using the Viscotek TDAmax system from Malvern Instruments was a key analytical tool in this work.

 

US Court of Appeals characterizes Wyatt Technology Corporation Lanham Act claims as “groundless, unreasonable, vexatious or pursued in bad faith”

30 May 2013: Malvern, UK:

Malvern Instruments Inc. has scored a decisive win in the final round of a long-running court battle waged by Wyatt Technology Corporation regarding the sale of Malvern’s Zetasizer Nano range in the US. Wyatt had alleged copyright infringement of software and other materials, false advertising and theft of trade secrets, and sought damages from Malvern in excess of $25 million (USD). However, Wyatt has ended up having to reimburse Malvern more than $2 million (USD) in respect of attorneys’ fees and costs.