Mark Rogers, Vice President, USA – Life Science, SGS
A: Within the past year, there have been several new technologies introduced into SGS, some of which have had an immediate impact, and others expected to be more influential over a longer term. One example that may fall into both categories has been the introduction of a hydrogen-deuterium exchange (HDX) service that, when used with micro-LCMSMS technology, can be applied to probe the interaction of large molecules as well as provide details of the dynamics, mechanisms and precise location(s) of the resulting molecular changes. This methodology provides orthogonal data to many other techniques such as FT-IR and CD, and in some instances, may eventually replace these. It is highly likely that in the near future, the use of HDX will expand into more routine applications of drug production, facilitated by automation of the hardware and software systems. Evolution and development of the technology may also afford extremely
rapid analysis.
Similarly, bio-layer interferometry (BLI) has the power to analyze molecular interactions in real time and can be used for protein quantitation, molecular binding affinity and kinetic analysis. Compared to existing technologies, BLI is faster, label-free and nondestructive and can be used on complex and unpurified samples. This means clients have access to a cost-effective and high-throughput analysis, allowing them to make decisions faster.
Mark Hammond, Commercial Director, Aesica
A: Our serialization capability is having the most impact on the business and we believe it also makes us a frontrunner in the industry.
We are one of the first CDMOs to have serialization implemented and fully operational across all of our packaging sites. We have developed a “module” that is both flexible and scalable, enabling it to meet the serialization requirements of a wide range of countries. The module is capable of high-resolution printing at fast line speeds, with an advanced communication protocol for remote operation and high-speed serialization.
We are seeing an increasing demand from customers for serialization and wanting products to be traceable online. Since legislation is already enforced in some of our customers’ product markets, we adopted serialization early in order to continue to serve our customers. EU serialization legislation, however, is set to come into effect in February 2019 and the industry appears to be slow to respond. Many do not have a robust plan in place and may need to rely on outsourcing this capability, such as to CMOs. We are continuing to invest in serialization to ensure that we have the capability in place well ahead of February 2019.
Natalie Landrito, Marketing Director, STEQ America
A: Within the last year, personalized medicine (or precision medicine) has surged to the front of the pharmaceutical industry.
In a recent Tufts Center drug development survey, 94% of companies said they were investing in personalized medicine research (up from 75% in 2010). Personalized medicine (which “converts DNA into data”) is halting the development of blockbuster drugs. Instead, large pharmaceutical companies are shifting their attention to more targeted therapies, realizing that the limited number of strengths and dosage forms currently available don’t support all patient profiles. As such, we’ve seen a substantial uptake of automated equipment that supports R&D for individual medicines. For example, the AR 403 (ERWEKA) is ideal for small batch sizes and features 22 interchangeable attachments. At a minimum, it’s ideal for the production of powder tablets, ointments, creams and cosmetics.
The RoboDis II fully automated dissolution tester, now capable of half and full pH changes (to precisely imitate the pH changes that occur in the body) has also made a recent impact. This move towards genome sequencing is augmenting the use of science and technology to distinctly identify which patients will benefit from a drug or experience an adverse reaction. This emergence also ties into the development of new high-tech apps and devices being worn by consumers to supportively transmit data to pharmaceutical research institutes. All of this is shaping the industry’s shift away from mass-production equipment to automated equipment that affirms the new generation of science, which sees no limitations on R&D and discovering tailored healthcare.
Andrew Bulpin, Head of Process Solutions Strategic , Marketing and Innovation, MilliporeSigma
A: The introduction of the Lynx® CDR connectors earlier this year really made a significant impact in the single-use space. This device changes the way pharmaceutical fluids are managed by allowing efficient fluid management through sterile connection, disconnection and reconnection — up to six times with one device. It does this by limiting the connection points into a single-use system, which simplifies fluid management, and reduces the opportunity to make incorrect connections. It also allows the user to connect in about 30 seconds, as opposed to the five minutes other systems can take. The Lynx® CDR connector is more efficient than tube welders, requires no capital and brings with it a heightened level of flexibility.
By design, the Lynx® CDR connector creates a barrier to the ingress of contaminants, providing the security found only in a clean room to ensure sterile drug processing. This device further enables the use of single-use technology by ensuring robust, simple, flexible, sterile connections in non-sterile, gray-space environments. The Lynx® CDR connector essentially provides the security of clean-room processing in the palm of your hand.
Harry Gill, Global Vice President, Operational Excellence, Patheon
A: Recently, we have made significant investments in sterile manufacturing technology, including state-of-the-art prefilled syringe and vial-filling suites, increasing our freeze-drying capacity by approximately forty percent. We have also invested in a sterile development suite at our Greenville, N.C., facility. Later in 2016, we plan to introduce the company’s first oral solid-dose continuous manufacturing suite as well. Lastly, we are in our second year of building a multi-year laboratory automation program, which will have every laboratory in the company on a paperless system.
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