October 26, 2018 PAP-Q4-18-NI-003
A: In the next 12 months, we are moving from automated experimentation to autonomous experimentation. Snapdragon is connecting our automated research reactor to optimization algorithms that will carry out self-directed experimentation to seek optimal reaction conditions using real-time feedback from in-line PAT. Autonomous optimization of chemical reactions will further accelerate the development of scalable, robust manufacturing processes. In the next 12 months, we will be expanding the capability for automated/autonomous experimentation to speed up discovery of new molecules using methods that are scalable-by-design.
A: To help counter the growing problem of counterfeit, diverted and adulterated medicines around the world, Colorcon is working with Applied DNA Sciences to advance an anti-counterfeiting authentication technology that will be suitable for on-dose application. This seamless solution integrates Applied DNA’s SigNature® molecular tags into Colorcon's film coating systems, which will provide the opportunity for pharmaceutical companies to apply them to their tablets and capsules.
Applied DNA molecular tags will provide traceability for audits and law enforcement and, perhaps most importantly, confirmation of the authenticity of the drug product to the patient and all those in the supply chain, including the pharmacist, the drug distributors and the manufacturers.
Colorcon has been granted the exclusive worldwide right to use Applied DNA’s molecular tags and associated authentication technologies in film coatings for oral solid dosage form (OSD) applications, for which Colorcon is the largest global supplier, and non-exclusive rights to use the company’s technologies in inks and colorants for OSD applications.
Applied DNA Sciences SigNature molecular tags and authentication technologies provide a valuable addition at a time when regulators are demanding that the industry implement serialization in order to track packaging. The technology provides a significant further step by enabling traceability at the level of single-unit OSD, and it is complementary to the provisions of the Drug Quality and Security Act.
Colorcon has wide pharmaceutical experience and knowledge relating to global regulatory compliance and holds representation with key industry associations, which will support companies’ implementation of this technology to their products.
A: One of the major reasons PCI Synthesis agreed to being acquired by Novacap is the growing demand, which will continue next year, for technologies and services associated with continuous manufacturing, flow chemistry and high-volume/high-pressure capabilities.
Another area of growth next year will be in combination drug–medical device products, which are growing at a CAGR of 7.9%, according to analysts, with the market expected to reach USD $177.7 billion within a few years. This trend of integrating active pharmaceutical ingredients (APIs) with medical devices continues to address various unmet medical needs and has created a demand for medical-grade cGMP polymers. Some examples of combination products include implantable drug pumps, drug-eluting stents and estrogen-laden vaginal implants. Given their facilitation of reduced treatment duration for patient convenience, cost efficiency and improved efficacy, new combination products continue to be developed. Consequently, we expect growth in demand for cGMP polymers to accelerate next year.
The burgeoning market for cGMP pharma foods is also expected to continue growing at a fast clip next year. What distinguishes pharma foods from nutraceuticals is that they cannot be bought over the counter: pharma foods must be prescribed by physicians and distributed by pharmacists.
Molecules are becoming increasingly complicated, and that trend will continue. As a result, next year will likely see continued strong growth for CDMOs, which is due in part to the increased difficulty, cost and need for specialized expertise in developing tomorrow’s APIs. Whereas, a few years ago, development of many APIs required just a few chemical steps, it is not uncommon today for the API development process to require many more steps than before. Getting from one step to the next adds considerable time to the development process at the same time that sponsors are under increasing competitive pressure to bring new drug candidates to market quickly. Next year promises to be a more challenging — and more rewarding — year for the CDMOs that can evolve to meet these market needs.
A: Neoantigen-derived vaccines have become a major new strategy within oncology as researchers look to harness the body’s own immune system to fight cancer. The treatment platform is completely individualized. Almac is very excited to be at the leading edge of this revolutionary approach to immuno-oncology. The systems and capabilities we have established are world-leading, but our vision goes beyond today’s performance, and we already have clear plans for how to deliver higher capacity and faster manufacturing rates.
Within our excellent enzyme capabilities, we are continually offering clients solutions that are economical, safe, scalable and high quality through the application of technology. We are fully committed to new technologies around biotransformations, catalysis and flow chemistry. The technology-driven process has proven to increase process scalability and lower the cost of goods, allowing us to compete at the world stage. Flow chemistry will be a key tool within our chemical toolbox, and we are excited to offer this to our customers in the very near future.
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.