Aesica Pharmaceuticals, a UK-based contract development and manufacturing organization (CDMO), recently relocated its development and clinical manufacturing services from Nottingham to Queenborough, from which it now provides API production, formulation development, clinical manufacturing services through to commercial-scale product manufacturing. The new development center has more than twice the capacity of the Nottingham site, and as a result provides significant scope for further business expansion. Contract Pharma recently caught up with Aesica’s managing director, Ian Muir, to talk about the new development center, the company’s service offerings, as well as trends and challenges in the contract solid dose manufacturing market. —TW
Contract Pharma: What was the motive for relocating Aesica’s development and clinical manufacturing services from Nottingham to Queenborough?
Ian Muir: We took the strategic decision to provide the market with a complete end-to-end service from a single development location. This has now been achieved. From Queenborough, with the establishment of the development center, we now provide a center of excellence for both API manufacturing, early to late stage clinical development all the way through to commercial-scale production.
CP: What is the game plan for the Nottingham site now that these services are no longer being offered there?
Muir: The new development center replaces the facility in Nottingham as a consequence of the strategic decision to provide a wider range of services from a larger Aesica facility. The previous R5 building at Nottingham was initially designed for start-up companies and was leased through BioCity. Due to the natural progression of the business, Aesica has moved the new development center to Queenborough to a facility, which it now owns.
CP: How does the move to Queenborough facilitate growth and what does it say about the direction your business is headed?
Muir: The establishment of the development center at the Queenborough site adds significantly to Aesica’s overall growth potential. It forms part of the company’s strategy to achieve further growth through the commitment to continuously improve and optimize the efficiency of how we supply our services to our customers. Indeed, by co-locating the facility at our largest API and finished dose commercial site, Aesica hopes to drive greater integration with the commercial site, reduce the risks of technology transfer for customers and reduce the overall development cycle time. The tech transfer component to this is especially important as it is central to ensuring the efficient and seamless transfer of a product from clinical development into the commercial manufacturing arena.
As a consequence of this strategic decision, Aesica now provides for the full manufacturing and development requirements of a wide range of pharma customers, including the virtual pharmaceutical companies—maximizing new business opportunities from the Queenborough site.
CP: What services will be now be offered from Queenborough?
Muir: The Queenborough site will now provide full API manufacturing, clinical scale development and manufacturing all the way through to the commercial scale manufacture of drugs.
The new development center will be a leader in the development of solid and liquid dosage forms, including the ability to manufacture clinical drug product for Phase I to Phase III studies. As the new center sits on a commercial site, the technical transfer from development to commercial will be a smooth transition for the customer. The development center will be able to handle potent and controlled drugs that mirror the commercial manufacturing offering from Queenborough. Aesica will also still offer semi-solid development.
Furthermore, inhalation services will continue apace with access to technology and knowhow, including metered dose inhalers (MDI) and dry powder inhalers being provided by Bespak within the Consort Medical Group.
CP: What is the scale and scope of this center in terms of capacity?
Muir: The new development facility will have the full capability to conduct formulation development for solid, oral and liquid products from bench scale through to pilot production and then, with the close proximity of the commercial operations, potential transfer into the commercial plant on the same site. The facility will also be able to handle potent compounds (excluding hormones and antibiotics) using dedicated isolator technology and dedicated processing suites. Formulation work will be supported with analytical method development, testing and stability services.
CP: Plans for future expansion at the site?
Muir: Aesica constantly reviews scope to further expand its facilities at all its sites including Queenborough, hence the establishment of the new development center, and we will monitor developments and opportunities closely in response to the evolving demands and requirements of customers.
CP: How would you describe the current state of the CDMO/CMO market?
Muir: Firstly, prospects for continued growth within the sector market remain strong. Equally, the market is becoming more competitive, with pharma customers looking for a smaller number of best fit CDMOs that offer high value services that will help them meet a range of industry challenges.
It is now absolutely imperative that CDMOs are reliable and that they provide consistent, high quality OTIF delivery services to their customers and the market. Solutions and practices are needed that enhance both cost effectiveness and process efficiency.
Crucially, there is a pressing market need to simplify and streamline supply chains, generating cost savings and optimizing performance.
CP: What would you say are the three key trends and/or drivers impacting Aesica’s business?
Muir: There are a number of key market trends that impact strongly on our business and provide solid opportunities for growth. There is a growing trend towards larger full service CDMOs which can meet the market’s pressing demand for consistent, high quality and reliable services across API manufacturing, formulation development, clinical and commercial scale manufacturing and also small, highly specialist boutique CDMOs.
There is also a highly significant trend back and towards increasing engagement of Western-based CDMOs for API, clinical and commercial scale manufacturing as Indian/Asian-based competitors become less attractive to pharma with rising costs and mounting concerns about the quality of service. In the case of API manufacturing, this trend varies according to the phase of development.
Certainly, when new products are being introduced to the market, pharma tends to strongly favor Western suppliers in order to mitigate risk. This trend differs in relation to compounds that are more advanced in the product life cycle, such as generics, where there is greater evidence of healthy competition between, for example, Asian and Western CDMOs.
There is also a major trend with pharma customers requiring greater value and enhanced performance and outputs from the overall supply chain. This includes developing solutions that enable more late stage customization to be carried out.
CP: Where are the opportunities for growth?
Muir: There are strong opportunities for growth in the CDMO market, especially for companies that can demonstrate high value service delivery, flexibility, reliability and optimal supply chain efficiency in the global market for API manufacturing, formulation development, clinical scale manufacturing and commercial scale manufacture.
CP: Conversely, what are the major challenges or obstacles in the market?
Muir: In today’s competitive market place, the need for CDMOs to provide exceptional value in the supply chain is of paramount importance. Addressing challenges in the supply chain is also particularly pressing due to the need to streamline and accelerate the route of drugs to market and to reduce the cost and complexity of development for pharmaceutical customers, as well as addressing the need to reduce working capital and free cash to support the development of new products.
The manufacture and supply chain model in the pharma sector urgently needs to adapt as a consequence of the number of blockbusters decreasing, and as global wealth is redistributed and markets take an increasingly individual approach to regulation. Add to this the therapeutic trend to ever more individualized medicines and the gap between the historical pharma model and the models of the major online businesses is clear. The challenge for the CDMO industry lies in how to bridge this in a safe and regulated way.
The scale-up challenge is also highly important as pharma is under pressure to meet all its production requirements in full.
CDMOs increasingly need to demonstrate a strong track record of implementing QbD, PAT and continuous improvement. Meeting the continuous processing challenge is becoming ever more critical due to the need to significantly shorten drug development time, optimize cost efficiency and reduce wastage during production and to find ways to execute drug development with smaller quantities of available high value APIs.