The Situation
A global IVD reagent manufacturer based in Ohio was scaling its production operations and needed a reliable, high-volume source of Immunoglobulin G (IgG) at 98% native purity—a specification well above standard catalog offerings. The initial order alone called for 2 kilograms of material, with an ongoing supply commitment to follow.
The program introduced several requirements Athens had not previously handled in combination: a customized buffer system tailored to the customer’s manufacturing process, elevated purity specifications beyond Athens’ standard IgG product, and defined packaging and aliquoting formats aligned with the customer’s internal production workflow. The requested volume also exceeded Athens’ existing open production capacity for this protein at the time.
Beyond the initial delivery, the manufacturer needed a structured inventory stocking arrangement—a program in which Athens would produce and validate a single large lot, then hold the material and release it in scheduled shipments over an extended period. This approach was critical to the customer’s operations: drawing from one validated lot across multiple production runs would eliminate requalification risk and ensure consistency in their downstream diagnostic products.
Why This Was Hard
Producing kilogram quantities of IgG at 98% native purity is not a straightforward scale-up exercise. IgG is the most abundant immunoglobulin in human plasma, but isolating it to near-homogeneity while preserving native conformation requires multi-step chromatographic purification under carefully controlled conditions. At higher volumes, maintaining that purity threshold becomes progressively more demanding—any compromise in process control shows up immediately in the final product’s electrophoretic profile and functional performance.
Layering in a custom buffer system and non-standard packaging added further complexity. The buffer had to be compatible with both the purification process and the customer’s downstream manufacturing steps. The aliquoting format had to integrate directly into the customer’s production line without requiring additional handling or reformulation on their end. Each of these customizations had to be validated at scale—not just at the bench—before the first shipment could be released.
For Athens, this program also represented a capacity challenge. The requested volume was larger than what the facility had been producing for IgG at this purity level. Executing the program required not just scientific problem-solving but operational planning to expand throughput without disrupting existing production commitments.
The Athens Approach
The program began with a structured technical kick-off meeting that brought together Athens’ Key Account Managers and R&D team with the customer’s technical and manufacturing groups. The objective was to align on every critical parameter before production began: purity specifications, QC acceptance criteria, buffer composition, packaging formats, production milestones, and delivery timelines.
From there, Athens’ R&D and production teams developed a scalable purification strategy capable of achieving the elevated 98% purity requirement at kilogram scale—while integrating the customer’s custom buffer system and packaging specifications into the process. This was not a matter of running an existing protocol at higher volume. The team engineered a production approach that addressed the specific technical constraints of this program, drawing on Athens’ proprietary library of purification methods built over four decades of native protein chemistry.
Regular progress meetings throughout the program kept both teams aligned as technical considerations arose. Because Athens manufactures entirely in-house at its USA-based facility, adjustments to process parameters could be made in real time—without the delays and communication gaps that multi-site or outsourced production introduces. This structured project management discipline was as important to the program’s success as the purification science itself.
The Result
Athens delivered 2 kilograms of high-purity IgG that met all customer QC specifications—ahead of the agreed timeline. The product exceeded the 98% native-purity requirement while fully incorporating the custom buffer conditions, packaging, and aliquoting formats the customer’s production process demanded.
With the initial delivery complete, Athens established a long-term inventory stocking program. A single validated production lot is held at Athens’ facility and released in scheduled shipments based on the customer’s demand. This structure gives the manufacturer the consistency they need—every shipment draws from the same qualified lot—while eliminating the supply uncertainty and requalification cycles that come with sourcing new lots from new production runs.
The program also delivered meaningful cost advantages. By producing at scale and committing to a multi-year supply relationship, Athens was able to offer competitive pricing that improved the manufacturer’s cost predictability as their own production volumes continue to grow. What began as a single large order has become an ongoing strategic supply partnership.
What This Means for You
If your IVD manufacturing requires high-purity proteins at kilogram scale—with custom specifications that catalog products can’t meet—Athens has the technical depth and manufacturing flexibility to build a solution around your process. Our scientists work with your team from specification through delivery, and our stocking programs are designed to keep your production running with consistent, qualified material, year after year.