Lisete Pinto is Product Development and Technical Support senior manager at Recipharm.

Lisete Pinto

The global biotechnology and pharmaceutical services outsourcing market is forecast to grow significantly over the coming years. Valued at US$63.1 billion (€64 billion) in 2020, it is projected to expand at a compound annual growth rate of 6.8% between now and 2030 to reach US$105.4 billion (€106.9 billion) (1). 

A number of drivers are behind this rapid growth, including the COVID-19 pandemic and the rise of biotech start-ups. At the height of the COVID-19 outbreak, pharmaceutical companies were globally involved in the campaign to develop effective and scalable COVID-19 vaccines. Many companies did not have the dedicated human resources and capacity in-house to develop and commercialize their vaccines in the timeframe required. Partnering with contract development and manufacturing organizations (CDMOs) allowed them to benefit from specialist infrastructure and development expertise. This move enabled companies to deliver viable vaccines to the international market at an unprecedented speed. Buoyed by this positive experience, many drug developers intend to continue outsourcing to CDMOs in the future.

Meanwhile, over the past three years, there has been a significant rise in the amount of venture capital (VC) funding invested in the biotechnology sector. VC companies invested in 3100 biotech start-ups worldwide in 2021, up from 2200 in 2016 (2). Biotech companies raised more than US$34 billion (€35 billion) globally in 2021, more than doubling the 2020 total of US$16 billion (€16 billion) (3). Many biotech companies are discovering exciting and cutting-edge treatments capable of transforming patients’ lives for the better. However, few have the capabilities internally to develop their innovations for clinical trials and beyond toward commercialization. As such, a growing number of biotechs are seeking CDMO support to help them realise the full potential of their advances.

In addition, pharmaceutical companies are turning to CDMOs for support as a means of mitigating the impact of challenges, such as higher development costs, increased risk caused by higher failure rates and growing regulatory pressure. Working with expert partners with the expertise and infrastructure already in place can help defray the expense of developing new products, minimising risk while providing companies with the capacity to focus on new projects.

While the advantages of outsourcing for pharmaceutical companies are clear, there are challenges facing any pharmaceutical company when outsourcing. A particular issue lies in transferring projects to new partners’ sites, which involves technology transfer.

Pharmaceutical technology transfer refers to the transfer of any process, together with its documentation/knowledge and professional expertise. This tech transfer can be between either the development and manufacture stages within the same facility or from an originating site to a separate receiving facility. Tech transfers are a critical part of any product development journey, particularly when working with a CDMO for all or part of the project.

Any transfer carries inherent business, regulatory, product quality, and technical risks. What is being transferred is not a physical asset, but an ability to create a product—this ability (or knowledge) is often challenging to define and specify.

Addressing challenges associated with tech transfers is vital to the success of any development project, particularly when outsourcing all or part of the programme. Failure to ensure a smooth technology transfer could cause unnecessary delays, impacting the success of the end product.

Tech transfers between an originator site and a receiving site generally follow a set itinerary that must be followed to ensure a smooth transition. A number of steps are involved, which may run in parallel, streamlining timelines. The key tech transfer milestones include:

Preliminary review and assessment by the receiving site of all documents related to the prior knowledge relevant to the development project. This will include analytical and process development reports, method and process criticality analyses, preliminary or ongoing stability data, compatibility studies, and qualification documentation, all of which are vital to begin the process of standardising procedures between the two sites.

Review gap assessment, which is normally done by both the receiving-site and sending-site technical teams. This procedure involves the assessment of the actual performance, characteristics, and requirements of the product being transferred against the receiving site capabilities, equipment, and procedures. This phase is vital to understanding the scope of work required and to determine the resource level that is required to prepare the product for the next stage in the development/transfer process. The assessment will be used to create the tech transfer plan, which will set technical, commercial, and regulatory requirements and associated timelines for key milestones in the process.

Development of regulatory strategy and process validation, in which the receiving site will draw up plans for implementation of all activities outlined in the tech transfer plan to ensure compliance with regulations and to lay the groundwork for submissions for regulatory approval once the development/validation process is complete.

Tech transfer closure centres around relevant reports relating to the technical activities undertaken, which are prepared and submitted to the originating site and/or relevant regulatory activities. At this point, the receiving sites should also be actively preparing product launch activities to be ready once regulatory approvals are available. Tech transfer reports may be issued, and, once complete, the tech transfer is considered finished. Product launch activities may happen thereafter.

The time taken to complete these steps will vary depending on the scale and complexity of the product being transferred. The level of product knowledge available at the onset of a transfer, as well as the technical maturity and streamlined processes of the receiving site may be integral to dictating the total duration of the transfer process. For more complex product transfers involving equipment acquisitions, and creation of product technical knowledge via the transfer process, the receiving site will be able to advise on the length of duration of the tech transfer process upon receipt of initial documentation and client requirements.

Both the originating site and the receiving site must address a number of potential pitfalls when undertaking a tech transfer to ensure success. Tech transfers are difficult-to-define tasks relating to inherently complex manufacturing processes that can have multiple variations depending on what discontinuities must be addressed.

The key challenges that are commonly faced by companies undertaking a tech transfer include:

Client expectations and initial project scope definition: the initial assumptions of the drug developer or marketing authorization holder (MHA) based on their initial information relating to the product can be a significant challenge. The MHA may have preconceptions about their product which will form their original plan for the project and for the tech transfer process. If these assumptions are incorrect, there could be serious ramifications for the tech transfer, potentially leading to costly delays and rework. Typical examples include product stability issues (typically on legacy products) being evidenced due to a change to more compliant analytical methods; change to product brought about by compliance-related requirements on legacy products, such as nitrosamines, and elemental impurities guidelines, etc.; and regulatory requirements being misjudged at the onset of the project, among other factors.

Product knowledge management: particularly when undertaking tech transfers of legacy products or products in the initial discovery phase, there may be a lack of technical knowledge on the product itself to make a comprehensive and robust tech transfer process. Some originating sites may have never undertaken a tech transfer before, so don’t know what information is needed or where to source the information required by the receiving site. Some sending sites may also not employ good documentation practices, and, thus, relevant technical knowledge or know-how may be lost, and the same challenges or issues may be met during the tech transfer process that could otherwise have been avoided if good documentation practices had been adopted previously. All this may contribute to slowing down the transfer of knowledge, with implications for tech transfer timelines.

Standardization at receiving site: another challenge typically faced by receiving sites of CDMOs is a lack of standardization of their internal processes and or documentation brought about by multiple tech transfers with varying types of clients with multiple requirements. This standardization will ultimately benefit project progress and timelines and will certainly drive improvements in productivity and operational excellence. Dedicated teams: another challenge is the creation of dedicated teams at both the originating and receiving sites to manage and coordinate the tech transfer. The originating site—particularly if it belongs to a small start-up—may not have team members with specialist experience in handling a transfer, so may need additional support in collating the required information to hand over to the receiving site. For complex or novel projects, the receiving site may need to reach out beyond its core tech transfer team to other colleagues with specialist knowledge to support it in drawing up and actioning an appropriate plan.

Communication between originating and receiving sites: transparency between the drug developer/MHA and CDMO is crucial to the success of any tech transfer process. Culture is key here—both sites should share an understanding to foster a positive, constructive, and supportive relationship and a sense of team spirit.

Innovations in technology are helping to address many of these common tech transfer pitfalls. An evolution in the processes used by experienced CDMOs as outsourcing rapidly becomes a mainstream feature of the drug development landscape is also occurring, which is helping to further reduce risk and streamline timelines.

Traditional ways of storing project data, via Microsoft Excel and Word, are increasingly being replaced by advanced digital knowledge management systems. These can help to automate the recording of information and help ensure that all relevant data are stored in one place. They can standardize the way the information is sorted and filed so that it is easy to transfer across from an originating site into the receiving site’s systems. Such tools can substantially streamline the tech transfer process, saving time and resources. As such, investment in these systems is expected to increase in the coming years.

Digital tools are also helping to circumvent challenges linked to geography. As seen during the COVID-19 pandemic, video conferencing and team management systems can help CDMOs and customers stay in touch with each other, helping them to coordinate and communicate without needing to be face-to-face. These can further streamline the tech transfer process in future, enabling collaboration and transparency even when teams are operating remotely.

In addition, outsourcing partners are rethinking how they support their customers during the tech transfer process, constantly reviewing procedures to further enhance the help they provide and adapt to a changing pharmaceutical landscape.

Many already have within their team specialists who have years of experience in managing successful tech transfers. Increasingly, CDMOs are bringing experienced team members together in dedicated tech transfer departments whose main responsibility is to work with customers to initiate the process of onboarding new projects at the receiving site. In addition to people with knowledge of the planning and process of a tech transfer, these teams are incorporating experts with insight into novel and niche drug products, such as cell and gene therapies. These experts can engage with the scientists at the originating site to understand and consider the unique tech transfer needs of unusual or cutting-edge products. They can help to minimize the risk of delays caused by challenges or requirements that otherwise wouldn’t be identified by non-specialists.

The trend for outsourcing development looks set to continue for the foreseeable future as a means for companies to deliver their discoveries to market faster and more effectively. Optimizing the tech transfer process is crucial to ensure that pharmaceutical companies are able to take advantage of the benefits of outsourcing.

CDMOs are well aware of the importance of getting the tech transfer right and are constantly reviewing and improving their internal protocols to deliver smoother, more efficient transitions for customers. Companies should consider CDMOs’ processes and the infrastructure to support tech transfers during the partner selection process to ensure that they have a supplier capable of helping them onboard new development projects efficiently. Doing so, companies can be confident that they have the support they need to overcome common tech transfer shortfalls, so they can bring their discoveries to clinical trial and beyond quickly and successfully.

1. Vision Research Reports, “Biotechnology & Pharmaceutical Services Outsourcing Market (By Service: Consulting, Auditing and Assessment, Regulatory Affairs, Product Maintenance, Product Design & Development, Product Testing & Validation, Training & Education; By End-use: Pharma, Biotech)—Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook 2021–2030,” Press Release, 29 Nov. 2021.
2. O. Leclerc, M. Suhendra, and L. The, “From 2019 to 2021, Venture Capitalists Plowed $35 Billion into Biotech Companies with Advanced Platform Technologies that Could Transform the Industry,” 

, 10 June 2022.
3. O. Leclerc, M. Suhendra, and L. The, “What Are the Biotech Investment Themes that Will Shape the Industry?,” 


Vol. 34, No. 11
November 2022
Pages: 30–33

When referring to this article, please cite it as L. Pinto, “Addressing the Key Pitfalls Hindering Technology Transfer Success,” 

Articles

In this article, the potential pitfalls of technology transfers are discussed as well as ways to ensure a smooth transition.