Enhancing customer satisfaction and service quality

This interview with Ralph O. Schoenleber, VP Research and Development at Bachem AG, was originally published by European Pharmaceutical Review, Issue 3/2017.

Which current area of research at Bachem do you think is the most exciting, or likely to have the biggest impact on pharmaceutical research and development?

Internal research projects at Bachem are primarily targeted to result in long-term commercial benefit. The continuous investment in development and implementation of new chemistries and technologies is regarded as crucial for future success. This is especially the case since stringent and costly requirements from authorities and the demand for more complex structures from clients require major efforts to remain competitive. In particular, the increasing interest in longer and significantly more complex peptides and peptide conjugates represents a challenge for all peptide manufacturers. Unlike biotechnological production, the synthetic access to these macromolecules allows for substantial fine-tuning of these structures. Therefore, products with tailored properties can be developed, offering opportunities to achieve patent protection for the optimized structures.


What advantages does your chemical glycosylation of peptides give to drug developers?

Glycosylation of peptide drugs can be a powerful way to enable optimization of lead candidates. Chemical glycosylation permits the synthesis of peptides and proteins with pre-attached sugars. It has been shown to markedly improve drug properties such as half-life, binding affinity and selectivity. Furthermore, compared to recombinant products, the chemically synthesized proteins are more homogeneous. Selective, site-specific glycosylation leads to a homogeneous product with potential for more defined bioactivity compared to heterogeneous products.


What technological challenges does the synthesis of longer and more complex peptides present and how are you overcoming them?

The enhanced interest in long peptides and even synthetic proteins is a logical consequence of the development in biology and chemistry. In particular, the progress in mass spectrometric techniques has facilitated the discovery of more complex peptides. As considerable progress in synthesis and ligation technologies has been realized, these molecules are well within the scope of current synthetic methodologies. Bachem’s research projects originate from the idea to continuously evaluate new chemistries and technologies to improve on existing processes in a dynamic fashion. Collaborations with external research partners like Prof. S. Kent are thought to complement these activities.


Can you summarise the key aspects of your ground-breaking and award-winning work on Interferon β-1a and how this has been taken forward by other researchers?

The partnership between Bachem and GlyTech is focused on the chemical development and manufacturing of glycosylated peptides. Bachem has the proven expertise to scale up and manufacture peptides at all volumes required, while GlyTech is capable of producing glycans in kg amounts by a proprietary technology. Bachem and GlyTech were 2013 CPhI innovation prize finalist for the work on Interferon β-1a. The selective chemical glycosylation has potential to be applied to a variety of peptides, where the concept of improving current and future drugs via chemical glycosylation. For a lead peptide, which has been chosen for glycosylation, a library of over 50 specific human type glycans is available. This technology has been used in multiple other projects, such as to manufacture glycosylated somatostatin analogues and glycosylated GLP-1. In all cases, drug improvements were achieved. Some of the glycopeptides emanating from the partnership are now in clinical trials.


What might the future hold for peptide research?

For a contract manufacturing organization in the competitive environment of pharma and biotechnology, research and development is extremely important to further enhance customer satisfaction and service quality. Constantly increasing demands on performance combined with growing sustainability requirements, such as those relating to occupational safety as well as waste management, are chief concerns of our markets. There is a continuous trend toward the development of molecules with higher complexity, and at the same time, the patent landscape is more and more crowded. Furthermore, requirements from customers and authorities with regard to documentation in general and data integrity in particular are changing the way people work.

In order to meet the increasing demands of the markets, a company needs the right combination of creative, innovative, but at the same time structured and accurately working scientists on board and to put a focus on the management of knowledge as a key factor to success. Efforts on knowledge management at Bachem focus on organizational objectives, such as continuous improvement, competitive advantage, innovation, and the sharing of “lessons learned”. Knowledge management includes expert systems, post-action reviews, cross-project learning, knowledge sharing, best-practice transfer, and collaborative software technologies (e.g. chemistry and technology forum including blogs). Fostering a culture that encourages the sharing of information, based on the concept that knowledge is not irrevocable and should be shared and updated to remain relevant, is a fundamental requirement for successful and future-oriented research and development.

Published by European Pharmaceutical Review – Issue 3/2017