Dear Valued Customer:
Proliant Health & Biologicals is committed to providing customers with unmatched service, products, and innovation. We decided to focus on a few internal improvement projects that are aligned with our most recent customer satisfaction survey as part of our continuous improvement process and to dynamically reposition ourselves in this ever-evolving supply chain to become more reliable, innovative, and resourceful.
The biggest change you will see within this year will be our rebranding effort: Proliant Biologicals USA, Proliant New Zealand and Entera Health will rebrand into Proliant Health & Biologicals with a revamped logo, without any change in the current ownership, manufacture locations or manufacture methods, raw materials/ingredients, regulatory status, finished product quality, batch size or availability.
Customers located in The People’s Republic of China may not receive products with the post-rebranding label and packaging until a later date due to potential delay from updating the GACC registration. Below you will see a link to examples of the new logo, rebranded label template, rebranded letterhead, and an example of the new universal Certificate of Analysis content. Examples of other service documentations, certificates, etc… are available upon request.
The scope of this change notification is limited to Proliant Biologicals’ Certificate of Analysis, Lot Number Assignment Plan, and product labels. The following changes will be applied to various product families:
- Adjustment to the format and alignment. General Proliant Release Specifications will be on the first page unless there are custom specifications in place. Extra tests requested by the customers will be placed on the second page.
- Lower the current Endotoxin specification for selected products from ≤3 EU/mg to ≤1 EU/mg without changing the current limulus amoebocyte lysate (LAL) method to maintain consistency.
- Protease limit for selected products will be adjusted from ≤0.005 units/mg to <0.001 units/mg, the detection limit of our current method. The specification will be “None Detected” with detection limit of 0.001 units/mg listed.
- Adding our internal release specification for our total aerobic microbial count/bioburden on the CoA for selected products and lowering the current release specification of ≤1000 CFU/g to ≤500 CFU/g.
- The method for our bioburden testing remains the same as plate count/pour plate method while adjusting the test standard to be aligned with the harmonized standard of USP <61>, EP2.6.12, JP 4.05 section I and modified ChP 1105 to eliminate any potential differences in testing standards across the world.
- The existing Lot Numbering System will be updated to an improved format. This change will not impact the traceability of the existing products manufactured prior to this change, nor have any impact on the current definition of lot or batch.
- Label format will be harmonized between different product lines to have a more unified appearance. Any existing product-specific recommended storage condition will be listed if applicable. The expiration date will be included on the labels based on the current shelf-life information found on our website. Each product family will have a different colored border for better aesthetics.
These changes will better reflect the uniformity of the manufacturing process and the consistent quality of BSA manufactured by Proliant across all locations. An example of the new universal Certificate of Analysis is available via the link below. SKUs impacted by those changes are detailed in Table 1 and the Lot Numbering System is detailed in Table 2 via the link below.
Proliant Health & Biologicals’ current target to implement the above changes applies to relevant products manufactured starting on June 1st, 2023. Customers may not see the new branding until July due to the time required for product release tests and shipment process. All products manufactured prior to this date, and not required to be stored below freezing temperature, will be harmonized by the end of 2023, without any change in their existing lot number. These efforts are part of our long-term commitment to continuous improvement as the world’s premier manufacturer of proteins supporting human and animal health applications.
Please direct any questions to your Proliant Health & Biologicals Sales Representative or Customer Service Representative.
Director, Quality Assurance
Please contact Proliant Biologicals sales or customer service if you have any questions.
View this notification as a PDF