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Small is the new big. Growth in specialty treatments that target smaller patient populations means less emphasis on economies of scale and more focus on adaptable and modular manufacturing.
High-value drugs may be manufactured in hundreds or even tens of thousands of units a year instead of in millions. Increasingly, products are piloted and manufactured using the same equipment. This changing backdrop throws into sharp relief the constant pressure that manufacturers are under to prepare and package drugs for trial as quickly as possible: today’s clinical or early-stage injectables packaging formats are more likely than ever to become tomorrow’s commercial presentations.
In this context, it is critical for biotechnology developers and other pharmaceutical operations engaged in clinical trials and scale-up to have at their disposal a range of closure choices to meet different small-scale needs. West has now added Daikyo’s new Ready to Use Validated® (RUV) to its existing offerings for small-scale manufacturing environments, extending customer options further in this area.
Sterile, ready to use Daikyo RUV stoppers are now available directly from West locations in North America and Europe with low minimum order quantities and accelerated lead-times. Daikyo RUV stoppers incorporate full vision inspection, subvisible particle specifications, and Drug Master File (DMF) support in the U.S. and Canada. They are based on a modern elastomer formulation that meets USP, Ph. Eur, and JP compendia requirements and lends itself to a range of applications, including those requiring multiple punctures.
Daikyo RUV small packs join a select group of premium West and Daikyo closure products in small scale formats that can be ordered directly from West locations in North America and Europe. These include West’s Ready Pack®, an offering that integrates ready to use, sterile Daikyo Crystal Zenith® vials, glass vials, seals and stoppers, as well as West NovaPure® components available in modern bromobutyl and chlorobutyl formulations. Small-scale manufacture has a range of needs and preferences to be met, and West provides a rich portfolio from which to select the best match for a specific project.
Our customers tell us that the advantages of high-quality pharmaceutical closures supplied on a small scale are clear. Lighter cartons containing fewer units can be shipped quickly and easily to where they are needed and are attractive in terms of lab and pilot-scale ergonomics. They can be stored and managed more readily than large packages and help avoid waste. Ready to use, sterile components furthermore eliminate the extra step of sterilization, which may be cumbersome, time-consuming, risky, or even beyond the scope of some sites.
To discuss your small-scale packaging needs and find out more about Daikyo RUV and RSV, contact your West Sales Accounts Manager.
<p>Demand is increasing for Daikyo’s sterile, ready to use closure components, known as Daikyo RUV® (Ready to Use Validated) components. Against that background, Daikyo has significantly expanded its packaging component sterilization operations to meet the needs of smaller customers as well as large scale pharmaceutical companies. By adopting an approach that replicates its existing footprint, Daikyo has been able to manage validation risks effectively, while meeting an ambitious timeline for bringing on new autoclave capacity. The result of this expansion is a state-of-the-art facility that triples the company’s previous sterilization capacity.</p>
There is an increasing trend in the pharmaceutical industry for ready-to-use components for a variety of reasons.
West is pleased to announce that it will begin distribution of a new Daikyo offering – the DAIKYO PLASCAP® RUV one-step press-fit vial closure solution for serum applications. DAIKYO PLASCAP RUV features an integrated stopper and plastic cap, offered in nested configuration for small-batch filling. The closure system offers an alternative to aluminum seals.
Research in the area of cell and gene therapies started almost 40 years ago, however recently there has been a surge of activity including landmark regulatory approvals for therapies treating chronic and rare diseases. In 2017 and 2018 the FDA approved the first two CART-T cell therapies for cancer treatment and the first two gene therapies for rare diseases. All four of these cell and gene therapies were approved under the FDA Accelerated Approval Program, aimed at expediting approvals for life saving drug therapies. These regulatory programs have the potential to shorten drug development as much as 1-3 years. Currently, there are more than 1,000 regenerative medicine clinical trials underway globally<sup>1</sup>, and the market is expected to grow rapidly over the next 10+ years.
Innovation in manufacturing involves a spectrum of evolutionary improvements resulting in what West’s partner Daikyo Seiko, Ltd. considers as “Absolute Quality.” Recent continuous improvement efforts helped Daikyo achieve even higher levels in cleanliness of elastomer products.<br />
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