Drug development and manufacturing is demanding. To achieve the best results from clinical trials to commercial manufacturing, an organization must consider all possible alternatives and strategies around production. For a pharmaceutical or biotech company, it is critical to consider not only drug development but also to develop a thoughtful commercial manufacturing strategy designed to achieve success in the market. A manufacturing strategy should be considered as soon as the drug development process begins. Often, the best decision for a company’s bottom line is to rely on an experienced manufacturing partner, with regard to the cost of development and time-related expenses.
To help make sure that the partnership with the contract development and manufacturing organization (CDMO) is mutually beneficial, certain factors must be determined. First, what are the market requirements and the product attributes, including dosage form? Does the partner organization have the capacity and experience to tackle the project? Will the drug be developed for out-licensing purposes, or will it also be commercialized by the company — and if so, in what markets? To establish the correct type of partnership, the commercialization strategy must be considered from the start.
Proven Strategies from a CDMO Perspective
There are many dosage options, including full vial development, full syringe/full cartridge development and parallel development approaches. The best route is highly dependent on the product’s attributes, the market requirements and the commercialization strategy. The majority of new products are initially filled in vial form; this approach is preferred because dosing studies are easier to carry out and there is a clear regulatory path. Vials are also preferred for companies dealing with highly restricted resources, including budget or market entry strategy. However, there are always exceptions.
A parallel manufacturing strategy (e.g., prefilled syringes or a pen/cartridge combination) can be advantageous when developing a new product or biosimilar for which an approved treatment or patented biologic exists. It is best to begin parallel development after dose-finding studies (phase IIb) have been conducted. Parallel development is most beneficial when dealing with less price-sensitive markets where there is a need to attract patients or for drugs that are administered by healthcare workers paid per administration step. If an organization chooses the parallel development approach, the regulatory pathway can also be pursued in parallel.
Choosing the Right Partner
It is never too early to involve a manufacturing partner. Selecting the right outsourcing organization is critical — the wrong choice can mean having to switch partners in the middle of a project, resulting in costly risks, such as failure to produce, loss of valuable API or trial delays. A local CDMO or formulation company with extended small-scale filling services may be an adequate partner at the start of a project; however, when the drug product completes early clinical phases, these partners may not be able to offer the additional services needed for larger-scale production.
Ideally, a pharma or biotech company will select a manufacturing partner with comprehensive development and manufacturing capabilities, global operations and broad and long-standing expertise. The selected partner organization must offer a range of services, from early development support to clinical filling, commercial manufacturing and various packaging solutions — and they must also possess strong regulatory experience and provide advice through all phases and processes.
Seeking a Global Leader Like Vetter
Vetter is a global CDMO that specializes in aseptic manufacturing of prefilled syringes, cartridges and vials. Because of our extensive experience with biologics and other complex compounds — including monoclonal antibodies, peptides, interferons and vaccines — we are able to support customers’ products from early clinical development to global market supply. We offer state-of-the-art technology and innovative processes to promote product quality and maximize API yields. As a result of all these capabilities and more, we are a strategic choice when selecting an outsource partner.