Tech transfer appears on the agenda of almost every biotech company. After identifying a suitable molecule, biotechs need support from external partners on the way to commercialization. However, many fear that tech transfer could slow them down or that they may be locked in with royalty fees. Working with the right partner can make all the difference.
Tech transfers come in many flavors. They may be performed at an early stage, when a biotech is ready to enter pre-clinical phase for a novel therapeutic candidate. Or, they may happen at a later stage when production and analysis procedures have already been established and clinical data are available. We interviewed experts from the Merck BioReliance® End-to-End Solutions team to demystify tech transfer and to share some best practices.
“Many biotechs do not have a long-term strategy, and that’s fine with us. After IND filing, some prefer to continue the development with a contract manufacturing and development organization (CDMO), others choose to either outlicense or sell their molecule to a pharma company,” Karima Medini, Senior Analytical Expert BioReliance® End-to-End Solutions at Merck, said.
“Our clients can take their project from milestone to milestone and remain flexible in their decisions. We do not lock them in with royalty fees but support them to quickly and flawlessly transfer their processes to the receiving pharma company, or take it to market on their own once they are ready.”
Tech transfer to CDMO
In a typical early-stage project, a biotech company has identified a therapeutic molecule and seeks support from an external partner to set up the production processes and analytical methods needed to achieve investigational new drug (IND) filing.
For many startup companies, this is the first time they are ever involved in a tech transfer, so working with a CDMO partner that offers long-standing expertise can make all the difference.
“Over the years, we have established an optimized process that helps us understand where biotechs are on their journey and find out how we can best support them,” said Laetitia Botrel, Head of Business Planning and Operation, BioReliance® End-to-End Solutions, Merck. “Once we have identified the gaps and evaluated the risks associated with a project, we can advise our clients on how to move forward.”
Multidisciplinary expert teams
A kick-off meeting is held at the start of every project, bringing together the people involved on both sides. Experts from all relevant fields (cell line development, upstream and downstream processes, quality control, and quality assurance), both for the development and the GMP stage, form a multi-disciplinary team and ensure a smooth project flow and constant communication.
“What our clients like most is that we are always available to answer their questions. They have a dedicated project manager as a single point of contact who ensures that the right people are brought in at the right time. The fact that we have all the experts in-house is very reassuring to them,” Botrel said.
Standardized information transfer
Once the team has formed, clients fill in a template providing all necessary information about the project, preferably at the raw data level. While the process as such is standardized, the time to complete it can vary, depending on the stage of the project.
“The shortest information transfer took only one day – the biotech partner sent us an email with the DNA sequence of their therapeutic antibody, and we took over from there,” Botrel recalled. “In contrast, if tech transfer is performed at a later stage, complete information transfer, including GMP batch information and clinical data, can take a couple of weeks.”
But even if GMP production has already been established, the team takes a step back. Before transferring the process to the receiving GMP production unit, they first reproduce the production and analysis at bench scale.
“In our experience, investing a bit of extra time greatly facilitates the overall process and has been a major reason why we have achieved a 100 % success rate so far,“ Botrel explained.
Speeding up with single-use
Applying single-use technologies can be advantageous as they speed up processes, increase convenience, and reduce risk. When scaling up from bench to GMP scale, the time needed for engineering runs can be shortened significantly if the equipment is simply plug-and-play, with no time spent on washing and sterilizing.
However, sourcing of single-use materials, resins, and filters should be performed as early as possible, so everything is at hand before starting the GMP production. “Especially during a pandemic, we have seen delays in the global supply chains, so we take extra care to keep our purchasing department in the loop,” Botrel said.
Addressing analytical panels
Besides production processes, analytical panels must also be evaluated. Methods that verify concentration, activity, and purity of a biologic can usually be transferred easily within a few weeks. In exceptional cases, methods have to be adjusted to ensure they can be demonstrated to the regulatory authorities as fit for purpose.
“Some analytical methods used at the development stage are optimized for high-throughput measurements but are not robust and precise enough for long-term or even commercial use,” Medini explained.
With the help of regulatory experts, the BioReliance® End-to-End Solutions team identifies equivalent methods to ensure that the procedures established in the lab of the biotech client yield identical results at Merck and meet all regulatory requirements.
No need to be afraid of tech transfer
Whether early or late, smaller or larger projects – with an expert CDMO partner at your side, there’s no need to be afraid of tech transfer.
“Over the years, Merck’s BioReliance® End-to-End Solutions team has established a robust program that facilitates and accelerates tech transfers at any stage and of any scope while providing full flexibility to our biotech partners,” Botrel concluded.
Find out more about how easy tech transfer can be with an experienced CDMO partner!
The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S and Canada.
©2021 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved.
Merck, BioReliance and the vibrant M are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the property of their respective owners. Detailed information on trademarks is available on publicly accessible resources.
Images via Merck