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Thursday’s Thought Leader Spotlight

Dr. Sam Guhan, Vice President of Engineering, Amgen, The United States

In a past interview with Dr. Sam Guhan, Vice President at Amgen in the United States, he addresses key questions in the integration of next-generation technologies onto the manufacturing space.


The Interview

| Given that the fast paced growth the industry is seeing, what are the key developments that are transpiring in the biomanufacturing space? In particular, when it comes to developing an efficient and seamless end-to-end manufacturing system.

Key developments include single-use systems, modularization and miniaturization in both a manufacturing and development environment. The biomanufacturing space is and will continue to see significant growth in the application of artificial intelligence, machine learning and deep learning as well as the application of computational modelling and advanced informatics systems to drive significant efficiencies in the future.

| What are some of the next-generation technologies that are being used for achieving integrated drug product manufacturing operations? Especially in retrofitting facilities and fill-finish operations?

Integrated single-use systems as well as novel adaptive and modular drug product filling systems such as Vanrx and Variosys are garnering interest in the industry as solutions for integrated DP manufacturing operations.

|Single use system technology has been the talk of the town in recent years. Highlighting a specific circumstance, how do single use systems streamline aseptic processing in the fill-finish process?

A specific example would be the use of sterile connectors in a drug product manufacturing environment which facilitates (a) a reduction in the potential for human error versus the previous state where it would be heavily reliant on manual assembly and processing steps (eg autoclaving) and (b) increased operational efficiencies in manufacturing operations.

| What are the cost advantages of next-generation technologies?

Key cost advantage of next generation technologies would be our ability to build a flexible (primary component agnostic and therefore able to process syringe, vial or cartridge) system that can be scaled appropriately depending on demand. This approach allows for lower capital and FTE costs. In addition, the use of these systems may allow conversion from a fixed-cost structure to a variable cost structure.

| How can we utilize next-generation technologies effectively to improve the adaptability of facilities?

Use of adaptive filling systems allows us to be flexible in terms of the primary container of choice.

| Low bio-burden needs to be maintained throughout the manufacturing process right until aseptic filling. What strategies do you suggest for achieving this?

Appropriate area classification and procedural controls are in place to ensure that bio-burden control is maintained for all stages of the process. These controls are used in conjunction with technologies including single use technologies prior to aseptic filling to ensure bio-burden control prior to filling and to ensure we can achieve this in an operationally efficient manner.

| What are the main challenges this industry faces in adopting next-generation technologies such as single-use systems?

One of the more significant challenges is that significant capital investments often have already been made at our manufacturing sites to create an infrastructure for our current state technologies (eg large stainless steel vessels and associated pipework; elaborate traditional filling lines and associated utilities). Moving from this current state to a state with integrated next generation technologies often requires significant capital investment to create a new infrastructure even before you invest in the new technology itself. In addition, justification for adoption of these technologies requires that their reliability and performance on a long-term basis be as good if not better than traditional systems which often have a proven track record over many years.

|  What are today’s quality considerations when integrating next-generation technologies into the manufacturing process?

Key quality considerations include: (a) increased reliance on external vendors (eg through the use of single use systems etc) results in a need to ensure quality standards in 3rd party sites and organizations; (b) increase in the use of complex materials as part of our processes (eg novel primary components in conjunction with novel filling technologies); (c) Continuous Manufacturing: Defining what is a batch; (d) Integrated processes – segregation of unit operations eg pre and post viral filtration steps; (e) establishing appropriate standard practices for next generation technologies (eg single use systems) compared to historical approaches for traditional technologies (eg integrity testing of stainless steel tanks versus certification of integrity from the vendor).


About Dr. Sam Guhan

Sam Guhan is the Vice President of Operations Engineering at Amgen. Dr. Guhan joined Amgen in 2003. Before Amgen, he was at Pfizer’s BioProcess R&D group. Dr. Guhan served as the Treasurer of the Biotechnology Division of the American Chemical Society, the Board for the Recovery of Biological Products Conference Series, and currently serves on the Governing Council of the Leaders for Global Ops group at MIT. He was awarded the VanLanen award in 2006 by ACS/ BIOT for services to the Division of Biochemical Society. Dr. Guhan holds a Ph.D. in Chemical Engineering from Rensselaer Polytechnic Institute.

About Amgen

Amgen, one of the world’s largest biotechnology companies in the world, was established in the United States in 1980. The company focuses on the development, manufacturing, and commercialization of pharmaceuticals in areas of high unmet demand in cancer, kidney disease, rheumatoid arthritis, bone disease, and other ailments.