MEET US AT THE BIOFIT IN LILLE
BioFIT is the leading partnering event in Europe for tech transfer, academia-industry collaborations and for sourcing early-stage innovations stemming from academia, startups and SMEs of the Life Sciences field It is our pleasure to inform you that we will be attending the BioFIT, which will take place on November 30 – December 1, 2016, at booth G10 at the Lille Grand Palais in Lille, France. We would like to meet with you to discuss how Bachem can help you with your peptide API custom manufacturing needs.
Bachem‘s pipeline contains more than 200 customer projects in preclinical and clinical phases. They all have promising potential: in the last two years, a number of products in phase III trials received marketing authorization and phase II projects progressed to pivotal phase III clinical trials. Some of our services include pegylated peptides, lipidated peptides, various other peptide conjugates, and sterile fill and finish (Clinalfa®).
A new service in our portfolio is the selective chemical glycosylation. The technology is applicable to large scale and has the potential to be applied to a variety of peptides, where we can pioneer the concept of improving current and future drugs. To view our recent webinar please click here.
As the Industry leader and pioneering partner, we promise to meet the expectations of our customers. We would be glad to arrange a meeting with you at BioFIT.
To schedule a personal meeting in advance please contact us.
QUALITY BY DESIGN
An efficient approach to quality design of peptide APIs.
Article by Michael Postlethwaite, Bachem AG
As an organization, we encompass the concept of quality as the core of all our processes and activities as an efficient approach for peptide APIs that is applied in close partnership with our sponsors. It is important that we recognize a formal methodology for the approach of building quality into every project by designing processes following the principles of Quality By Design (QBD). QBD is “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and control, based on sound science and quality risk management.” and is encompassed under ICH Q8 At the very beginning of the development lifecycle, the sponsor is involved in discussions and decisions related to the desired product quality. This process builds from the deep foundations of Bachem’s prior knowledge, using our experience to identify risks emerging from the theoretical and early practical design of a manufacturing process. In this stage the first opportunities to understand the relationship between the individual process steps and the product quality target profile arise. At the same time we start to introduce control strategies, or monitoring strategies as appropriate and to place the design of the manufacture onto the correct path. Good examples of this relationship would be the reliance of Identity on SPPS, or purity on the characteristics of the purification process. The journey through development is very well established, starting with feasibility work or transfer from the customer (non-GMP), through early phase GMP work (Phase 1 / early Phase 2), into process validation (Phase 2 / Phase 3) and finally launching into commercial market supply.
To build quality into the journey, it is necessary to gain as deep an understanding as possible of the process, and to obtain a full understanding of the relationship between every stage of the developing process and the quality of the final product. Only once this understanding exists a commercial process that delivers the best quality of material for the intended use can be finalized. To gain this insight, a continuous review of the entire manufacturing process is required. This approach enables us to proactively identify potential risks at every stage, based on the current developmental stage and experience of the ongoing process. This is conducted in close partnership with customers, as well as the risk mitigation steps taken after this systematic review. Risk assessment is undertaken during the process development: Ideally there are 2 cycles, one during the early GMP development, and a second during scale-up into the final process and batch size for validation readiness. Risk assessment is performed using FMEA (Failure Modes and Effects Analysis) which is a systematic procedure for the analysis of a process or system, in order to identify the potential failure modes, their causes and effects on system performance in advance. Based on science, a review of the entire manufacturing process is undertaken to allow evaluation of the current process knowledge. From a prioritized list of manufacturing risks this is generated which is then used to focus resources and establish the priorities for further process characterization or optimization activities leading to the next stage. Risk mitigation strategies emerging from FMEA often include improvement of MBPRs, additional or enhanced in-process controls (IPCs) or knowledge gaps being closed using prior knowledge or additional experimental work. Bachem typically works together with the customer following FMEA to identify work packages targeting risk mitigation leading to validation readiness.
Bachem’s comprehensive quality assurance network oversees the design and risk assessment / mitigation strategies by using the principles of quality risk management according to cGMP. The strategy is to use science and process experience to drive the evaluation of quality risk by making an ultimate link with patient safety. This requires both, a proactive approach (to identify up-front aspects that may cause concern), and a reactive approach (dealing with unforeseen outcomes and events during development). A control strategy is eventually designed and agreed for the manufacture, validation and commercialization.
The principles of QBD do not stop once a process has been validated for commercial supply. In this phase, the process must be monitored for continuing quality performance, but also subjected to a systematic assessment of potential improvements. This is through a process of Continued Process Verification (CPV), which calls for identification of CAPAs, risks and improvement opportunities through the comprehensive and statistical analysis of data collected through successive manufacturing campaigns. This naturally also provides a continuing increase in the process understanding. In this stage Bachem takes the approach to formulate a CPV plan, written and agreed together with the customer, which defines the monitoring strategy and ensures the process is always optimized. Any actions identified for improvement can be undertaken through a rigorous change control system, maintaining compliance with the quality management systems. Bachem’s approach to Quality By Design starts at the very beginning of the development cycle, and continues as long as we manufacture that product (even after process validation). Science and knowledge are the keystones to adopting and driving process and quality risk mitigation activities. The process is designed around the quality of the material, and is focused on patient safety at all times. We stand by the principle that in partnership with our customers we strive to build quality into each and every stage of a manufacturing process.
MEET BACHEM: MICHAEL POSTLETHWAITE
What is your official job title at Bachem?
Business Development Manager
How long have you been with Bachem? Where did you work before Bachem?
Bachem for 3 years – First in intercompany projects, then in Project Management and now in Business Development team. Before I worked in GSK & Pfizer UK, and for A*Star in Singapore.
Briefly, what do you do at Bachem?
Responsible for business in the UK (but with extra projects in Europe)
What is your academic background/degrees or training?
BSc and PhD, specializing in Neuroscience
What do you like to do outside of work (interests, hobbies)?
Passionate about old cars, but little time to follow actively. Winter sports and playing music also rate highly. Being from the UK, I can also claim passion for beer tasting.
How is the Marketing & Sales team partnering with their customers?
We work with increasing day-to-day engagement with customers – listening and learning as well as providing interactive advice and service oriented discussion.
How big is the Marketing & Sales team at Bachem and how are they set up?
Like the whole of Bachem, the sales and marketing are growing quickly – we are set up to be very interactive with each other, and this helps us progress our business.
What is your business motto?
Bring engagement and confidence to the product.
Have you had any particular expectation when you came to Bachem and have these been fulfilled?
I expected a collaborative working atmosphere, but the friendliness and helpfulness of everyone far exceeded this.
Do you like to communicate any key message to the reader?
Engagement brings confidence – we can use that to sell our products and services.
What is your preferred peptide?
Being a former Neuroscientist, Ziconitide fascinates me from its mode of action, as it opened a new strategy for management of chronic pain.
Thank you very much Michael.
Interesting news about peptides in basic research and pharmaceutical development:
Engineers design a new weapon against bacteria-MIT
Peptides vs. superbugs-Science Daily
New peptide research could alter sperm motility and impact on male fertility-University of Wolverhampton
Cancer killers: C dots show ability to induce cell death in tumors-Cornell University
Bachem peptides and biochemicals are widely cited in research publications. Congratulations to all our customers with recent publications!
Xiaoliang Wang, Zhaoyue He, He Liu, Shida Yousefi, and Hans-Uwe Simon
Neutrophil Necroptosis Is Triggered by Ligation of Adhesion Molecules following GM-CSF Priming
J. Immunol., Nov 2016; 197: 4090 – 410
Matija Hedl, Deborah D. Proctor, and Clara Abraham
JAK2 Disease-Risk Variants Are Gain of Function and JAK Signaling Threshold Determines Innate Receptor-Induced Proinflammatory Cytokine Secretion in Macrophages
J. Immunol., Nov 2016; 197: 3695 – 3704
Sampada S Bhagwat, Anett K Larsen, Ole-Morten Seternes, and Berit E Bang
Mixed exposure to bacterial lipopolysaccharide and seafood proteases augments inflammatory signalling in an airway epithelial cell model (A549)
Toxicology and Industrial Health, Nov 2016; 32: 1866 – 1874
Nadine Mykicki, Alexander M. Herrmann, Nicholas Schwab, René Deenen, Tim Sparwasser, Andreas Limmer, Lydia Wachsmuth, Luisa Klotz, Karl Köhrer, Cornelius Faber, Heinz Wiendl, Thomas A. Luger, Sven G. Meuth, and Karin Loser
Melanocortin-1 receptor activation is neuroprotective in mouse models of neuroinflammatory disease
Science Translational Medicine, Oct 2016; 8: 362 – 146
Sören E. T. Luczak, Sander H. J. Smits, Christina Decker, Luitgard Nagel-Steger, Lutz Schmitt, and Johannes H. Hegemann
The Chlamydia pneumoniae Adhesin Pmp21 Forms Oligomers with Adhesive Properties
J. Biol. Chem., Oct 2016; 291: 22806 – 22818