A significant number of life sciences companies specifically focused on drug development are thriving in Scotland. It’s a sector estimated to be growing at double that of Europe’s average. David Stevens, senior director and site head, tells the story of AMRI Glasgow, a company going from strength to strength here.
AMRI Glasgow develops and manufactures sterile dosage forms – either liquid or lyophilised products. In terms of manufacturing scale currently - primarily we manufacture for use in Phase I & II clinical trials. We’ve seen significant revenue growth over the past several years – averaging over 35% annually.
Our customers include the full spectrum of biopharma customer, from VC or grant-backed virtuals and emerging companies to mid and large biopharma. Geographically, around 60% of sales come from Europe, 30% from US and 10% from Oceania and Asia.
AMRI Glasgow can provide the formulation development and lyophilisation process development expertise as well as GMP manufacturing capabilities within the same building.
This single site location helps enable customers to progress from pre-formulation through the key development milestone, “Proof of Concept”, without incurring time delays, loss of product knowledge, multiple CMO audits or technical transfer costs at the early stages of clinical development.
There is critical mass of scope and diversity in the drug development sector within Scotland, throughout the critical path of pre-clinical and clinical trials, formulation development, manufacturing and testing. I believe there is something in the region of around 160 pharmaceutical services companies to choose from here.
We’ve seen numerous customers spend a week in Scotland visiting their current or prospective supply chain partners, saving significant time and expense by accessing world-class expertise and capabilities within a stone’s throw of each other, right here.
This benefits the Scottish AMRI operations. Many of the related upstream and downstream activities relating to pre-formulation, process development, formulation development, testing and GMP drug product manufacturing can be sourced within a 100 miles of the AMRI Glasgow site.
We’ve seen numerous customers spend a week in Scotland visiting their current or prospective supply chain partners, saving them significant time and expense by accessing the world-class expertise and capabilities within a stone’s throw of each other, right here in Scotland.
Our location in Glasgow is strategically significant for AMRI internationally. Geographically, the site provides the global AMRI business a footprint within drug product development in Europe it hadn’t had until the recent acquisition of the business in Scotland.
Crucially, AMRI can now leverage its global sterile development and manufacturing capabilities to provide additional service options to the considerable European customer base developed by AMRI Glasgow. During the past year alone, the Glasgow site has worked with over fifty unique customers with around 60% of sales coming from Europe.
During the past year alone, the Glasgow site has worked with over fifty unique customers with around 60% of sales coming from Europe.
ADC acceleration ahead
Cyotoxic parenterals offers a fantastic growth opportunity for AMRI Glasgow, driven by anti-cancer therapies and other highly potent compounds. Specifically, Antibody Drug Conjugates (ADCs) as they are often referred to are an extremely exciting and interesting sub-segment of this market.
In contrast to traditional chemotherapeutic agents, antibody-drug conjugates target and attack the cancer cell, so that healthy cells are less severely affected. AMRI Glasgow is able to develop the ADC formulation and then GMP manufacture the cytotoxic liquid or lyophilized finished ADC product – few competitors across the world offer this capability.
The ADC market is projected to grow at a spectacular rate over the next 3 years – around 80% on a compound annual basis. AMRI Glasgow actually did the early development work on one of the two ADC products on the market already, so we have a story to tell prospective customers.
Help from Scottish Enterprise
Scottish Enterprise provides support for pharma companies in Scotland. Including free events which provide vital intelligence and insight, opportunities to attend international trade events and expert advice on key overseas markets. Contact us to find out more.
Going through the phases
Looking ahead, we have completed a £1m upgrade to our cytotoxic filling line. This will enable us to offer customers larger batches and greater sterility assurance – putting us at the leading edge of both the market and regulatory requirements within sterile cytotoxics.
We are also looking at more transformative future capital investment plans for the AMRI Glasgow business. This is to offer customers’ continuity of supply at the site beyond Phase II, through Phase III, as well as the potential to provide liquid and lyo commercial supply for orphan indication products.
The reasons for this are compelling, like the significant cost, time and risk involved in doing technical transfers to another facility at the end of phase II. This would enable the site to nearly double its capacity.
Plans are in the early stages, and we have held discussions with Scottish Enterprise on how they can help support this diversification and enhancement of the site’s capabilities – just another benefit of being located in Scotland!
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