A: Green chemistry is at the forefront of minds within the chemical industry, and utilizing our enzyme technology is becoming the norm rather than the exception. Within Arran Chemical Company (acquired by Almac in 2015), our AdaPT (Arran Deploys Advanced Product Technologies) strategy and through a multi-million Euro investment and application of our selectAZyme™ technology, we have remained at the forefront of innovation to ensure our customers receive best-in-class solutions. Our team has researched more than 30 projects in the last year involving multi-disciplinary research on enzyme optimization and chemical process design. Another key milestone was winning the Irish Industrial Chemistry Award for the achievement of complete commercialization of an enzyme immobilization process involved in a medical device destined for the U.S. market.
2018 also saw Almac launching our High Throughput GMP Peptide facility manufacturing neoantigen-derived peptides — branded by Almac as NeoPeptides™ — for use in the production of patient-specific, individualized cancer vaccines. Speed is critical within this therapeutic context, as the entire supply chain is focused on minimizing “needle-to-needle” time (i.e. the time between the initial patient biopsy and the ultimate vaccine administration). Almac Sciences’ experts have been associated with the individualized cancer vaccine field for several years, and its facility and systems have been set up to enable fully GMP compliant manufacture and release of 20–30 GMP peptides within less than three weeks.
A: Colorcon continues to provide solutions for pharmaceutical technology and manufacturing trends to meet the industry needs for coating flexibility and productivity while addressing patient adherence by making tablets easier to swallow.
Opadry® QX Quick and Flexible Coating cuts across technology barriers and equipment limitations, delivering production efficiency across all coating equipment. This advanced system greatly reduces preparation and coating times, ensuring process efficiency and cost savings in all types of equipment — from traditional pans to continuous coating equipment — while still delivering color uniformity and a high-quality finish. The high productivity and flexible coating conditions reduce the exposure time of the product to the rigors of the coating process, and therefore temperature- and moisture-sensitive drugs are better protected.
In an environment where the senior population is on the rise and more people are taking multiple medications and dietary supplements (some of which are large tablets and capsules), swallowability is a growing concern. Regulatory agencies around the world now provide guidance regarding the importance of tablet coating, not only to address differentiation by use of colors, but also to ease the swallowing of tablets and capsules and improve patient safety and compliance.
Through extensive research and development, Colorcon has developed and recently launched Opadry® EZ, Easy Swallow Film Coating System, which is a new innovative technology to address the difficulty faced by many patients in swallowing oral solid dosage forms.
A: As a busy CDMO, we are always looking for new opportunities to expand our toolbox, and this year was no different. There are several reasons for this. The first is to make development of cGMP materials faster, cheaper and more efficient for our sponsors. To that end, we carefully evaluate new technology exhibited at the industry meetings we attend. For example, this year we have augmented our capabilities in cryogenics, micronization, large-scale chromatography and lyophilization, to name just a few.
And we are not just looking for new technology and equipment to add. We are also constantly developing and evolving new chemistry and new techniques that we can use to solve similar problems on future projects. That’s how we came up with products such as medical-grade azelaic acid.
As a result of our expertise in GMP polymers and our ability to scale up quickly, our biggest area of growth this year has been in the polymer space, at the intersection of active ingredients and material science. We are one of the few CDMOs with dual expertise in both cGMP API development and cGMP polymerization. Our customers, ranging from small companies to the largest pharmaceutical and medical device companies, are benefitting from the efficiencies inherent in these combined proficiencies.
This year saw marked growth in our cGMP manufacturing for pharma foods. These food products for human and veterinary markets contain pharmacological additives meant to improve health. Regulated by the FDA, pharma foods must be produced under cGMP and are only available by prescription. Pharma foods are a new frontier that is blurring the lines between pharmaceutical companies and food companies. The sector is wide open to innovation, and companies from Nestlé to Abbot Labs are jumping in. Many others, large and small, are too.
A: Although continuous flow has been utilized in similar industries for over a century, the pharmaceutical industry has been slow to adopt this technology for a variety of historical and regulatory reasons.
The strategic initiative made by Cambrex to develop a continuous flow Center of Excellence in High Point, NC aims to strategically fill the shortfall of continuous flow process development capabilities within the CDMO industry supporting the pharma industry. The intent here is to leverage its use with the trend of higher-potency materials and niche indications, all of which require smaller overall production volumes. Additionally, Cambrex recognizes that a significant population of clients are seeking continuous flow to be incorporated for production of their early clinical candidates, whether to solve key issues with hazardous intermediates, purity concerns or instability of bulk intermediates on scale.
The recognized advantages of a continuous flow process lie in the ability to carefully control both the quality and consistency of the API being produced, with a much lower long-term capital investment. Cambrex’s investment brings this capability to the clinical production space and allows for rigorous development of robust continuous flow processes that can be readily developed and scaled up to commercial manufacturing sites. The final flow process is developed faster, due to a reduction in scale-up time frames and technical transfer hurdles, while still enabling increased safety and product quality.
Process development work undertaken at High Point can now be seamlessly transferred to any site within the Cambrex global network for commercial manufacture, and another practical advantage is that the development skids can be easily truck-transferred to the commercial site to reduce timing to commercialization.
A: The low cost and availability of IoT (internet-of-things) technology continues to have a significant impact on our company this year. Snapdragon develops chemical manufacturing processes that rely on the integration of a wide range of mechanical and electronic components. We use IoT technology to coordinate the working of complex flow systems. We are also able to continuously harvest rich data sets from these systems with IoT-enabled sensors and process analytical technologies (PAT). This combination of automated equipment and sensors in our laboratory systems enables automated experimentation. We can rapidly perform large numbers of experiments and gather incredibly rich data sets from every experiment. This capability delivers much greater process knowledge and leads to more rapid process development and ultimately more efficient and controlled processes for drug substance and fine chemical manufacturing.
By leveraging efficient and simple programming languages, such as Python and HTML, along with open-source code, IoT has allowed us to design highly automated and easy-to-use tools for lab- and pilot-scale chemical process research. These tools, in combination with well-engineered flow reactors, are delivering accelerated process development cycles and right-first-time scale-up.
Mike has been the Director of North American Business Development for Almac Sciences for the past ten years. Mike earned his PhD from Cornell University and worked in Chemical and Polymer R&D for the first 10 years of his career. He transitioned to Fine Chemicals Business Development and worked with several CMOs prior to joining Almac.