Allan Aginsky, Vice President, Special Projects & Manufacturing
Tell us about your career journey.
My career history includes executive/senior management positions at Abbott, Merck, and Genpharm, with roles such as plant manager, vice president production, and general manager. Since 2000, I have served as president and founder of API Partners, providing manufacturing site establishment consulting, active pharmaceutical ingredients and finished product sourcing.
I have conducted quality audits/reviews at sites in over 24 countries, and have established many sites for pharmaceutical production, spanning a wide range of products from injectables (both aseptically filled and terminally sterilized) to oral solids. My clients have also achieved accreditation from regulatory agencies that include Health Canada, US FDA, UK MHRA, China FDA, India and New Zealand.
Why did you choose to join API?
From my very first introduction to API, meeting Andrew MacIsaac (CEO) and Micheal Guirguis (Manager of Pharmacokinetic Services), it was on a most positive foot. They had a grand vision, a defined target, determination, motivation and enthusiasm that I readily bought into. They wanted to save lives and do the right thing for Canada. This is aligned with my life objectives.
They started development of one of the strategic anesthetics that is subject to continual drug shortages in Canada at their own time and cost. Without these strategic anesthetics, emergency and elective surgeries are cancelled, which in many cases has resulted in catastrophic consequences.
Tell us about your proudest career achievements.
One of my proudest career achievements has been saving a technology transfer for a brand product. The brand company previously had a few attempts at the technology transfer with some large consulting companies, but the challenge had proven too big for them, both from a logistic (obtaining the correct active pharmaceutical and excipients specifications) and equipment sourcing (manufacture and IQ/OQ/PQ) point of view as well as the process validation (PV).
Our experience, focus and discipline, derived from completing numerous technology transfers worldwide in different environments, proved to be a game changer for the company.
In 13 months, the product was tech transferred with the client saving their product and market share.
What are some of the challenges that companies face with technology transfers and setting up new facilities?
These are both very intricate processes. There are no shortcuts to meeting Good Manufacturing Practice (GMP) standards. Each step needs to be designed and implemented carefully to achieve the desired objective.
It all starts with proper management support and personnel buy in. The team must be disciplined, and must pay attention to every detail along the way. My team and I have been brought in, in numerous cases, to ‘clean up the mess’. One client, a very large pharmaceutical company, learned the hard way. They went with a consulting company who ‘promised’ them a specific timeline, etc.
In the end, we almost had to restart the project because it wasn’t done properly, and the company spent millions of dollars on lost materials and lost time. We were able to turn things around quickly for them, but they still entered the market one and a half years later than originally planned.
Can you tell us more about what’s required to set up a manufacturing facility?
The process is complex, and requires experts like myself, with years of hard earned hands-on experience, to execute. Generally, it follows a defined roadmap that all participants have agreed on. It begins with evaluating the products and processes to determine the facility needs and develop a master facility, equipment and personnel specification. Following that, a site must be identified, and then the design phase can begin. This includes looking at airflows, pressure differentials, processing room specifications, people and materials flow, and obtaining all of the necessary architectural, engineering, environmental, safety and regulatory input.
The next step would be to evaluate the selected products for sourcing (in-licensing) for development, followed by determining the equipment needs for manufacturing, laboratories and utilities. Then, you’d need to determine and evaluate all of the software required such as Enterprise Resource Planning (ERP), Quality Management System (QMS), Building Management System (BMS), Documentation System, Laboratory Information Management System (LIMS) and much more.
In the final steps, you evaluate for staffing requirements, policies and procedures, finalize the program, and then move into the implementation phase. There are a lot of moving parts to get a facility up and running properly.
COVID-19 has further emphasized the need to have vaccines and other medications manufactured locally. What would having large-scale manufacturing capabilities in Alberta mean for the province and the life sciences sector?
Larger scale production of vaccines would allow Albertans access to vaccines months ahead of other provinces. The larger scale production would also be able to attract interest from other countries without such facilities. A Made in Canada (Alberta) product is always a major plus, especially as some of the current suppliers (outside of Canada) started protecting their medications for their own populations.
Without local vaccine production and filling, there won’t be any vaccines available for Canada in a short timeframe should another crisis arise. The objective is that Alberta would also initially strive to produce essential medications. This will ensure patients have access to the life-saving medications they need. In this regard, we are looking to make one or more of the key anesthetics for surgeries and other specialized injectables.
Why are their continuous backorders for medications and vaccines?
One could write a dissertation on the causes.
The key factor here is the tender system that was introduced to bring down the pricing of medications to make them more affordable for patients. The result is anything but. With the lowest price, there is no incentive for any company that loses a tender to keep any stock on hand. So, when a company supplying is unable or unwilling to continue supply for whatever reason, Canada is scrambling to obtain alternate suppliers worldwide. The COVID-19 pandemic further highlighted this by some countries restricting exports to Canada of these key products.
Companies are interested in the bottom line as it has an impact on their operating expenses. A company not supplying product has to pay penalties, but may choose to go this route as it is less expensive than production. If no alternate supplier is available or is not approved by Health Canada on an emergency basis, patients aren’t able to access the medications they need. This is why we need local production NOW more than ever.