Fast Track Kits for Research and Clinical Trials

June 30, 2020
Fabian Stöcker, Pharma Insights Contrib., VP Global Strategy & Innov. SCHOTT Pharmaceutical Systems
Fabian Stöcker, Pharma Insights Contrib., VP Global Strategy & Innov. SCHOTT Pharmaceutical Systems

Fabian, having joint SCHOTT AG in 2012, is Vice President Global Strategy & Innovation for the SCHOTT Business Unit Pharmaceutical Systems Within the management team he is responsible for strategy, product management, product development, IP management and market intelligence covering ampoules, cartridges, pre-filled syringes and vials for injectable use. Prior to this, he was heading the corporate strategy department of SCHOTT AG being responsible for corporate development, strategic planning and portfolio management of the whole group.Fabian studied business administration at the University of Cologne/Germany and the Corvinus University of Budapest/Hungary and holds an MBA from the University of Cologne. He is a Chartered Financial Analyst (CFA) charterholder from the CFA Institute, Charlottesville/USA.

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The global pharma industry drug pipeline is bursting with more than 3,800 injectable drugs of which more than 70% are biologics in clinical phases

The global pharma industry drug pipeline is bursting with more than 3,800 injectable drugs of which more than 70% are biologics in clinical phases (1). These drugs tend to have smaller target populations than their small molecule counterparts, which has led to an increase in smaller batch sizes. Moreover, they require special attention as their complex molecular structure is prone to interact with primary packaging materials. Subsequently, the rise of biologics has resulted in the need for packaging solutions that are suitable for smaller batch sizes, while ensuring drug stability throughout the entire shelf life.  

Adding to this is that new drug development has generally never been more expensive, competitive, and complex. The average cost to develop a new drug from discovery to approval is estimated near $2.6 billion. That’s more than double the $1 billion in costs in the early-2000s (2). The time between initial investigations and drug approval can last 10–15 years (2). Hence, all new drugs including biologics and even unprecedented events like the COVID-19 pandemic are challenging the global pharma industry to reduce the time to market for new drugs without compromising patient safety.

Increasingly, research is driven by smaller companies. Novel therapeutics arise from complex networks of universities, research organizations, startups, and small biotech companies. According to HBM Partners New Drug Approval Report, 63% of drugs approved in 2018 originated at a small biotech firm (3).

For small companies, startups, research organizations, and even R&D groups in big pharma, fast and easy access to high-quality primary packaging components at the small volumes used in early research and clinical trials is a challenge.

In order to meet these new requirements, SCHOTT is introducing Fast Track Kits, providing a pre-tested fully sterile system composed of pre-sterilized pharmaceutical glass containers and matching drug delivery components and closure systems. This offering simplifies the process of ordering primary packaging in small volumes as needed in early research and clinical trials and thereby accelerating time to market. The Fast Track Kits were developed together with industry-leading elastomer manufacturers of high-end components.

Traditional Small-Quantity Procurement Is Inadequate

Conventional pharma production and supply chains are designed for large-volume commercial production. Suppliers have typically required orders of 50,000 pieces or more, often with lead-times of several months. Pharmaceutical companies need to order the glass containers independent of the closure system such as stoppers and crimps or drug delivery components such as plungers and plunger rods, which adds complexity in supply chain and mandates additional testing by customers.

As the trend indicates, most new drugs originate at small biotech firms and startups that do not have the need for large volume orders and, in a competitive environment, cannot wait months for their primary packaging. Additionally, containers are often not available in a pre-sterilized, ready-to-use format requiring additional cleaning procedures.

In essence, the current solutions are not in tune with the new market developments and may hinder both small and big companies to bring new drugs to market faster.

 

 

Accelerating Time to Market

This changes with SCHOTT Fast Track Kits. They consist of SCHOTT’s adaptiQ® ready-to-use vials in the ISO 2R, 6R, 10R or 20R formats together with matching stoppers and seals. Other containers of the SCHOTT iQ® platform such as syriQ® prefillable syringes, as well as the new cartriQTM ready-to-use cartridges, will be added in the near future.

The Fast Track Kits allow startups, research institutions, drug development teams, and others to source all of their materials from a single source. Each combination of stoppers and vials is pre-tested and fully documented, with corresponding container closure integrity (CCI) reports, product specifications, drawings, and extractables report to simplify testing efforts.

The ready-to-use glass vials have been developed for complex biological drugs, featuring ultra-pure materials and superior manufacturing processes to reduce the risk of drug/container interactions. These high-quality containers arrive pre-sterilized in a tub and nest that prevents glass-to-glass or glass-to-machine contact throughout the entire fill-and-finish process, which becomes especially useful when transferring from drug development to commercial production.

Fast Track Kit is based on the partnership between SCHOTT and West Pharmaceutical Services, Inc. (West). West offers similar solutions with its Ready Pack® containment system. Both systems consist of sterilized premium line NovaPure® stoppers, gamma-sterilized Flip-Off® CCS seals and SCHOTT's adaptiQ® ISO vials. All Ready Pack® components are capable of meeting the challenges of today’s sensitive, high-value biologics and small molecules. They are provided ready-to-use, from stock, and for fast delivery.


 

Further offerings with SCHOTT’s ready-to-use containers in small quantities will be available in combination with Datwyler (Starter Pack™) as well as Aptar Pharma (QuickStart™).

Easy Access and Fast Delivery

The full system can be easily accessed and ordered online at the SCHOTT web shop (https://shop.schott.com/pharma). The shop features a product configurator to provide customers with information about the available high-quality combinations, offering all required components pre-tested and CCI compliant from one single source. Furthermore, a simplified ordering process, and availability of various product combinations on stock, ensure short delivery times of one week instead of months.

With the SCHOTT Fast Track Kits, clinical development can be de-risked by offering pre-tested, pre-validated solutions that are readily available for commercial production. It means companies can rely on the same container performance at commercialization as they did in R&D. This helps small biotech companies, universities, and even large firms accelerate time to market, bringing life-saving medicines to patients faster.

 

References 

1. Pharma R&D annual review 2020, Pharmaintelligence, Informa UK Ltd 2020, https://pharmaintelligence.informa.com/resources/product-content/pharma-rd-annual-review-2020-whitepaper

2. Congressional Research Service, Drug Pricing and Pharmaceutical Patenting Practices, February 11, 2020, https://fas.org/sgp/crs/misc/R46221.pdf

3. HMB Partners, HBM New Drug Approval Report, https://www.hbmpartners.com/media/docs/industry-reports/Analysis-of-FDA-Approvals-2018-and-Previous-Years.pdf

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