Scheduling Aseptic Filling for Preclinical and Clinical Batches

A biopharmaceutical sponsor’s selection of a CDMO partner is a matter of finding the appropriate partner for a particular job. While a prospective partner’s qualifications may appear acceptable on paper, its company culture, the priority it places on a client’s project, or its availability to schedule client aseptic filling runs may not make it a good fit.

Drug Development and Project Scheduling Challenges

Operating in the drug development space – primarily for small-batch aseptic manufacturing for preclinical and clinical use — Singota is keenly aware of the project scheduling challenges faced by our clients. We have built our business with the understanding that many factors affect drug development timelines, from the intricacies of cutting-edge chemistry to the unpredictable-at-times availability of raw materials, that are often beyond our clients’ control.

Project scheduling challenges faced by drug developers range from the highly technical to the mundane, either of which can be unpredictable and frustrating. A biopharma’s active pharmaceutical ingredient (API) manufacturer may have difficulty producing and duplicating the formulation after earlier successful batches, resulting in unexpected delays. The API could be compromised during shipment, held up in customs, or lost during shipping. During the formulation development process steps, solubility and stability problems may be encountered and necessitate excipient and/or process changes, leading to project delays. Further, the COVID-19 pandemic has lengthened manufacturing lead times due to shortages of supplies, instrumentation, equipment, and raw materials.

Operator loading Singota’s Vanrx SA25 with a nest of vials

Singota’s Scheduling Approach

An understanding of the dynamics of the development space guides a key aspect of Singota’s approach to aseptic filling process and manufacturing scheduling. Singota has designed its aseptic filling project processes to accommodate the “bumps in the road,” helping clients to their feet when a project stumbles, rather than punishing them further for occurrences common to this industry. This innovative approach empowers us, and our clients, to better dedicate resources toward our shared vision: expeditiously delivering life-changing therapies to the patients who need them.

When we begin working with a client, together we identify a target window for their fill, rather than a specific date. As the project progresses, we continuously monitor and narrow the production window down to the span of a couple of weeks. Only once all the necessary documentation and other pre-fill tasks are imminent is the fill date hard-coded into the schedule. This dynamic approach allows both parties to accommodate some of the unforeseen delays in the development process.

If the client experiences an unexpected delay late in the project, preventing the batch fill from happening during its scheduled week, Singota will schedule a new fill target as soon as possible after the issues have been resolved. We can very often “pull in” another aseptic filling process project to occupy the vacated space in our manufacturing schedule. We can contact other clients and say, “We’ve got an opening. Could you be ready to go?” It may be a company we’ve already filled for, so they can quickly take advantage of an earlier fill. Perhaps their project utilizes bulk drug substance already on hand.

In other cases, we may have finished a filling project early, creating an opening. In this manner, the scheduling of Singota’s aseptic filling and manufacturing process is dynamic.

How Singota Achieves Truly Flexible Production Scheduling

Small Batch Sizes

Fills used for developmental purposes (from a few hundred to several thousand units), can be completed in a matter of just a few days, enabling Singota to manage aseptic manufacture scheduling changes more easily than is possible for long batch runs.

Fill Equipment

Singota’s production equipment also helps us to be flexible. The company utilizes the Vanrx SA25 Aseptic Filling Workcell to run either vials, syringes, or cartridges with minimized setup times.

Incoming Material Format

Vials, stoppers, syringes, etc., all arrive pre-sterilized and ready to use, eliminating the need to spend extra time on washing, sterilization, siliconization, depyrogenation, etc.

Simplified and Streamlined Batch Records

By using the RTU container formats and the fully robotic, integrated isolator/filling unit, our batch records are simplified and streamlined, allowing shortened project lead times and efficient use of resources that enhance project schedule flexibility.

On-hand Container and Closures Inventory Management

Singota minimizes potential delays by remaining well-stocked with commonly used containers/vials/syringes.

Company Size

Singota is a small CDMO and our size, in part, enables our scheduling flexibility. A large CMO booking commercial lines with tight, back-to-back schedules — comprising batch sizes of several hundred thousand units, each of which could take many days — is much more difficult to manage in terms of shuffling slots around to accommodate delays.

Our Mission and Company Structure

From the company’s beginnings, Singota was set up to support the development of drug products and to quickly get these products to patients that need them. Our organizational structure, focus, systems, processes, and approach to client project management are dedicated to doing things right the first time by being accountable, agile, and transparent.

Final Thoughts

Many CDMOs have unique technical proficiency and reputations built on past successes. Thus, the differentiator between several viable choices is, “how will this partner go the extra mile for me where others will not?” Singota sets itself apart by its commitments to its clients, working with them to achieve success, and treating them the way Singota would like to be treated. From our collaborative project management meetings to being flexible on aseptic filling process schedules, we strive to offer an unmatched client experience.

At Singota, accountability, transparency, flexibility, and trust are not just marketing words. They are qualities sponsors value and expect when selecting a partner who is responsible for moving a project ahead using precious materials. Singota understands the problems clients encounter in the drug development process. We offer a collaborative and fresh project scheduling and manufacturing planning approach to manage expectations, avoid delays at the outset, and then minimize delays as the project progresses.