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Need for a contemporary manufacturing strategy?

Need for a contemporary manufacturing strategy?

Consider a parallel development approach to differentiate your drug product in developed market segments

Beginning with in-human phase I trials, significant thought is applied to study design, logistics, CRO selection, patient populations, study centers, software and clinical distribution. These are all important considerations in the drug development process, but what is often missing is an equally important, well-thought through manufacturing strategy for the clinical material.

Dr. David Brett, Product and Service Manager at Vetter provides answers about a clinical manufacturing approach that meets the needs for aseptic filling of high value antibodies, proteins, peptides, etc.

Question: Innovative drug products in development are on the rise. What kind of drug products or molecules are most suitable for a parallel manufacturing strategy?

Dr. Brett: The decision for the right packaging strategy strongly depends on the market requirements, the product attributes and moreover the company´s commercialization strategy for its new drug product. For a new product or biosimilar where there exists an approved treatment or patented biologic in syringe or cartridge form, there can be a competitive advantage using a parallel manufacturing development strategy: Focusing on vial first often allows a faster time-to market strategy while developing in parallel in syringe offers the clients a more flexible commercialisation strategy. This is true in less price sensitive markets where there is a need to attract patients, and vials offer a price advantage. This is also the case where health care workers are being paid per administration step, receiving higher reimbursement from insurance companies using a vial. For example, we recently experienced a parallel manufacturing strategy for clients developing for indications like autoimmune diseases and blood products. It offered them the flexibility to approach unique market segments with differently priced and positioned offerings.

Q: At what phase does a company needs to decide to kick off a parallel vial-syringe development?

Dr. Brett: The majority of new products are initially filled in vial form since it is easier to carry out dosing studies and the regulatory path is clear. Many biotech companies choose this development path due to their restricted resources, budget and market entry strategy. The best timing to consider parallel development is after dose finding studies (Phase IIb). These clinical trials usually represent the most rigorous demonstration of a medicine's efficacy. Sometimes referred to as pivotal trials. In this clinical trial phase it´s best to think early not only about primary but also secondary packaging components to be best prepared for scale-up and commercialization.

Q: Do you need to pursue regulatory processes twice or in parallel when choosing a parallel manufacturing strategy?

Dr. Brett: The regulatory pathway can be pursued in parallel following an FDA Guidance. It is essential that biopharmaceutical clients work with a partner that has strong regulatory experience and is regularly audited to highest manufacturing standards, both in early clinical and later stage clinical phases. Each primary packaging configuration needs to meet specific regulatory requirements.

Q: How much are the extra cost for a parallel drug development strategy?

Dr. Brett: It is difficult to give a concrete number for a parallel manufacturing development strategy. Certainly, it is more expensive to pursue a parallel development path. However, depending on the product attributes, market requirements and commercialization strategy it is advised to consider starting feasibility studies in both syringe and vial packaging as a first step without committing to full development of one or the other pathway.

The choice of a high quality manufacturing partner with the contemporary manufacturing capabilities and expertise to offer advice on future drug product development is critical. The wrong choice can leave biotech companies with the need to switch partner’s midstream, resulting in high cost and risks such as failure to produce, the loss of API or trial delay.  Vetter offers a large expertise in primary and secondary packaging components and strong regulatory expertise .