The internationally recognised leading exponent of whole process design for the process industries, UK-based Britest Limited, has entered into a licensing agreement with Micropore Technologies, to allow Micropore to use a defined set of Britest’s established process understanding tools. In conjunction with their own proprietary technologies, this will enable Micropore to create models to support their internal evaluation of potential applications. Britest will also provide technical development support for Micropore clients.
For manufacturers seeking drug approval for controlled release therapeutics using liposomes and LNPs, stability under shelf and in vivo conditions has been a problem to date. This is particularly true if the API is released in unintended ways and locations through changes in temperature, pH or shear stress, particle fission & fusion, lipid oxidation and hydrolysis, leakage; and loss of hydrophilic cargoes. Control of the interaction between phospholipids and water molecules, is key to making liposomes and LNP structures with the desired morphology, encapsulation efficiency, stability and size. The FDA’s “Guidance for Industry” concerning liposome drug products emphasises the importance of size and size distribution as “critical quality attributes and essential components for stability.
Currently there are five main methods of making liposomes at lab scale, allowing for size control from around 20nm up to several microns and composing of one or more bilayers, and a smaller number of larger-scale techniques. However, all of these techniques have the potential to degrade the efficacy of APIs due to the application of mechanical stresses (e.g. high shear, sonication, high pressure, etc.), use of unsuitable chemicals (e.g. volatile organic solvents, etc.), or by producing extremes of pH. Commercially available high temperature methods, in which the lipids are heated to around 80oC, exemplify the challenges towards more widespread approval and uptake of these drug delivery systems.
Recent work by Micropore Technologies has demonstrated that their aseptic membrane-based technology, already used for the formation near mono-dispersed PLGA microspheres, can equally be used as a refined micro-mixer for liposome and lipid nanoparticle production. By enabling the mixing of two miscible liquids together in a controlled manner achieving very narrow size distribution at, or below, room temperature, damage from high temperatures, pressure or shear can effectively be eliminated. LEARN MORE
An article by VANESSA ZAINZINGER for Chemistry World
Innocore to deploy Micropore technology in the production of a new generation of long acting injectable drugs
In addition, because Micropore’s unique patented technology is based on a crossflow technique utilising tubular membranes, with no moving parts, the minimal shear forces involved in producing the microcapsules will help to protect the sensitive biological drugs that InnoCore’s microparticle products incorporate from processing damage – significantly reducing wastage (which can be up to 50% using traditional encapsulation techniques) also reducing processing energy by around a 30% - all of which will contribute to a positive impact on the end cost of InnoCore’s products.
Following the recent announcement that it is establishing an office in Hyderabad, Micropore has confirmed the appointment of Govardhan Rao, a bio process specialist, as its Sales Development Manager for India.
Govardhan holds a masters degree in Applied Microbiology and has two decades of rich experience in Business Development and Sales & Marketing in the key Asia Pacific Bio-Process market including India, China, Japan, Korea, and Singapore. He led Asia Pacific regional marketing for a Bio Process business unit based in Singapore and has worked with some of the world’s leading Bio-Process companies including Lonza and Thermo Fisher, leading a project on "Sterility Testing of Parenteral's" at a reputed Bio-Pharmaceutical company. Govardhan brings an in-depth understanding of the Bio-Process field as well as cell culture projects to Micropore and has been honoured as speaker at a World Bank funded Capacity Building Program for empowering personnel from Indian Government Drug testing laboratories and small scale industries from year 2004 to 2008.
“What sets Monad apart from other local distributors is that we specialize in providing custom-made solutions developed from advanced and patented technology ingredients, packages, and equipment. We are constantly looking to add more innovative partners and their products to our growing list of associates.”
Micropore Technologies has launched the latest up-scaling of their award-winning membrane emulsification technology. The Micropore AXF-7 is a high throughput device, capable of the continuous manufacturing of in excess of 10,000 tonnes a year of high-quality emulsions, with tuneable particle size distribution. This new device takes Micropore’s patented technology to a new level, delivering the precision of microfluidics at the production volume potential of traditional industrial homogenisation, together with the opportunity for hugely improved energy efficiency.
The ability to create high quality emulsions, formed from uniform size droplets, all with the same performance, creates inherently more stable products reducing creaming and sedimentation. Less emulsifier or surfactant is required, reducing raw material costs. And, with a much lower shear force, sensitive materials are able to be more gently processed without damage – significantly reducing wastage.
Other benefits that clients have seen from Micropore’s membrane emulsification technology include; elimination of waste (typically a minimum of 10% using conventional emulsification techniques); a 30% reduction in energy use; a reduction in regulatory burden; high return on investment; and significant reduction in equipment footprint.
The new AXF-7 is constructed to the aseptic standard required by cosmetic, food and pharmaceutical manufacturers and features robust and reliable, precision-engineered, internal tubular membranes, with no moving parts. The substance to be dispersed in the emulsion is pumped through the membranes, passing through the laser drilled micro pores whilst the continuous phase substance flows through the body of the device providing the shear force necessary to deform and detach the droplets as they form through the membrane.
It is the precise size and distribution of the pores in the membrane that enable the production of near mono-dispersed droplets at precise sizes of the client’s choice from 10 microns up to 1 mm. Adjusting the flow rates of each substance allows different droplet sizes to be created and even at high flow rates the coefficient of variation remains low at around 10-15%.
The new AXF-7 unit completes Micropore's range of devices that starts with a benchtop laboratory test unit for initial scoping studies, the results from which translate directly to a flexible development device for optimisation of operating parameters before the data generated is used to customise either the AXF-1 or AXF-7 for full-scale manufacturing.
Emulsions produced through the Micropore system can be post-processed and turned into microcapsules for a variety of active delivery systems, with the highly uniform capsule sizes produced behaving in exactly the same way, thus reducing unwanted rupture variability.
“The AXF-7 builds on the proven performance of our AXF-1 unit, launched 18 months ago. Now, for the first time, manufacturers can benefit from crossflow membrane emulsification, with all of its inherent advantages, at the production volumes previously only possible with large-scale homogenisation equipment.”
Dai Hayward, Microspore CEO.
Micropore was delighted to be present at the New York Society of Cosmetic Chemists Suppliers’ Day 7-8 May at the Jacob K. Javits Convention Center in New York. Now in its third year, this event provided an excellent opportunity to meet existing customers and profile Micropore's unique technology to this important sector.
With the success of its recent product development and a growing order book from customers worldwide, Micropore has secured a further £860,000 investment to support the expansion of its UK manufacturing facility and its business development team.
This new funding includes £750,000 from NPIF - Mercia Equity Finance (which is managed by Mercia Fund Managers as part of the Northern Powerhouse Investment Fund) and further funding from UK Steel Enterprise. These new funds take the total raised by the company to date to approximately £1.5m.
Micropore Technologies were one of just eight winners in the RSC (Royal Society of Chemistry) Chemistry Means Business awards. This was a showcase of success and innovation in the sector across the UK and Europe, took place at the Queen Elizabeth II Conference Centre in Westminster on 15 October, complete with sweeping views of the Houses of Parliament and the London Eye.
The focus of the event was our Emerging Technologies Competition final, in which 39 candidates – from a mixture of start-ups, SMEs and university research spin-outs – pitched their ideas to panels of experts in a ‘Dragon’s Den’ style competition. Ideas had to fit into one of four categories, Food and Drink, Materials and Enabling Technology, Energy and the Environment and Health.
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