Speeding medicine delivery with One Day Batch Release | Takeda Stories

When a viral disease outbreak spreads throughout a region, the ability to meet the immediate increased demand for preventive tools and medical care has a tangible impact on people’s lives. Rapidly spreading diseases can result in experiences such as missed work or school, severe symptoms and in some cases can even be fatal.

When patients with a rare neurologic disease have been waiting for treatment, every minute between approval and delivery of the medicine counts.

And when patients depend on a medicine to help manage their gastrointestinal symptoms, even the smallest inefficiencies in the product manufacturing and release process can delay delivery.

Takeda’s “One Day Batch Release” program aims to ultimately deliver medicines to patients more quickly and reliably while maintaining the highest safety, quality and efficacy standards. To achieve this goal, the program is intended to simplify and harmonize all steps in a medicine’s batch release process into one digital and automated end-to-end pathway, significantly accelerating product release and availability of medicines for patients while enabling operational efficiencies. By incorporating digital technologies and automation alongside human expertise, the company has set the ambitious goal of releasing batches in as little as one day.

Head of Plasma-Derived Therapies Quality Barbara Glantschnig explains: “One Day Batch Release represents a commitment by Takeda to innovative methodologies, where automation and agility empower our teams to simplify processes end-to-end in the value chain, and focus on aspects that truly matter. This transformative program accelerates the delivery of safe, high-quality products to patients worldwide.”

Over the past two years, the program has been implemented at six pilot sites across different parts of the business that include the manufacturing of vaccines, small molecules, biologics and plasma-derived therapies. They were selected based on their involvement in manufacturing high-volume, high-demand products as well as certain pipeline products with anticipated near-term launches. The success of the six pilot sites has paved the way for this approach to be rolled out across the company.

For example, Takeda’s vaccine manufacturing facility in Singen, Germany, has applied a series of technical and process improvements that have brought the average batch release time down from more than 30 days to 19 days – and one batch was released in just seven days.

Head of Vaccine Product Operations Anita Rehberger highlights how this achievement was driven by the team’s commitment to patients. “Working on vaccines for infectious diseases, our team was acutely aware of the human impact we could have if we released vaccine batches more quickly. The progress we’ve made to date has shown us what’s possible, and we have strong momentum as we work toward our goal of even faster batch releases.”

Before a batch of medicine can be released for distribution to patients, it undergoes a disposition process to ensure manufacturing and testing of the product meets current good manufacturing practices as well as local compliance requirements. This is the final quality assurance process that involves a comprehensive review of all data required for product release. Release decisions depend on information from multiple systems – manufacturing, laboratory, quality, logistics and regulatory – often requiring significant manual effort to collect, reconcile and assess evidence. One Day Batch Release began by simplifying and streamlining the processes involved in batch release. The program is now using digital technologies to centralize release-relevant data across systems, enabling a more efficient, standardized and transparent release process. Rather than replacing foundational systems, this “release hub” brings them together, ensuring that quality specialists have timely, consistent and reliable information to support release decisions. This eliminates the need for manual evidence gathering and reduces inconsistencies across systems.

Emphasizing both innovative technology and process improvements, One Day Batch Release takes a three-pronged approach:

• Review by exception (data review automation): Creating a framework whereby systems flag anomalies in electronic batch records, based on established rule sets, for human review.
• Release of the future (release process simplification): Simplifying batch release processes by removing redundancies and unnecessary complexities and establishing a globally harmonized standard for batch release.
• Release technology (technology standardization): Standardizing the data and technology required for batch release, paving the way for a companywide release hub that will act as a trusted control tower for batch release.

One Day Batch Release Lead, Michalina Szatała, underscores the importance of this program for all Takeda medicines, including marketed products and those in late-stage clinical development. “One Day Batch Release is a key piece of our enterprise digital transformation. With three anticipated product launches over the next 18 months, it’s critical that we have the technology, tools and processes in place to ensure these products can reach patients as quickly as possible.”

Site Quality Head at the Singen site, Carola Bleeker, agrees and believes we are already benefiting from the efforts underway to improve the batch release process around the world. “Thanks to the perseverance of our cross-functional team, we are cracking the code on the batch release process for our vaccines. And by collaborating and exchanging best practices with colleagues in other manufacturing sites, we are confident that we can see similar positive outcomes across the company, enabling us to provide high-demand products to patients more quickly than ever before.”