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
Micropore Technologies today announced a Collaboration & Licence Agreement with InnoCore Technologies BV, Groningen, The Netherlands to deploy its patented technology, for the manufacture of InnoCore’s SynBiosys® long acting injectable drugs.
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.
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.
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.
Micropore AXF has been awarded an Innovation Award for Pharmaceutical Equipment innovation by Pharmaceutical Manufacturing.
On 22nd May Micropore participated in the Tees Valley Venturefest innovation showcase. During this one day conference, held at the Wynyard Hall Country House Hotel in County Durham in the north of England, Micropore was presented as an example of how to build a business based on innovative technology.
I have been involved with CCI since its foundation by the late Tom Swan and it is a pleasure to continue to support its valuable work through Micropore some 20 years later.
Micropore CEO Dai Hayward
Micropore have donated £2,000 received from the 2018 NEPIC (North East Process Industry Cluster) Innovation Award to the highly successful Children Challenging Industry (CCI) programme aimed at teachers and children in primary schools, and science-based manufacturing companies in the UK.
The CCI programme aims to improve the perception and understanding of science and industry by teachers and children. The programme combines classroom science lessons led by expert advisory teachers, with visits to industry, to enhance teachers’ confidence and tailored to meet the needs of the science curriculum.
Micropore were delighted to be invited to participate in the event to celebrate the Innovate Tees Valley programme held at Wynyard Hall in Teesside on Tuesday 20th March. This will be followed by a showcase event on Tuesday 22nd May, also to be held at Wynyard Hall, where Micropore will join other cutting-edge businesses from the region demonstrating of the incredible innovation that is currently underway in the Tees Valley.