Tech Briefing: How Good is Good Enough?
How good is good enough? As scientists we are trained to make our assays not just good but the best. However, sometimes taking that last step, going from good to best is a nearly impossible feat and requires more resources than it took to develop the assay in the first place. That brings us back to how good is good enough? (Hint, the answer is NOT: “good enough to pass regulatory scrutiny”). A typical answer, most of us can chant the phrase is that it must be “suitable for use”.
Tech Briefing: The Importance Of Being Potent (with apologies to Oscar Wilde)
The need for potency assays for biopharmaceutical therapeutics has been recognized for some time. The regulatory agencies from all ICH-abiding countries require one or more potency assays as part of the release suite of assays associated with DS and DP. Entire programs have been put on clinical hold for lack of a well-reasoned and supported potency assay.
Tech Briefing: ELISA and USP 1123.1 Interest Groups at BEBPA’s 2024 HCP Conference
The 2024 Host Cell Protein Conference will feature two Interest Groups on Day 3 which will be available only to in-person attendees. BEBPA conferences are well-known for their collegiality, opportunities for networking, and speakers/attendees who “tell it like it is,” and this is due in large part to conference Interest Groups and Workshops.
Reference Standards for Potency Assays – Considerations for the Preparation and Storage of In-House Standards
Volume 1, Issue 5: As potency of a biopharmaceutical product is determined by bioassay relative to a reference standard (RS), the development and establishment of a suitable in-house RS is an important activity. As drug development proceeds, with possible changes in the manufacturing process and formulation, it usually proves necessary to replace an earlier RS with one that is representative of the current production or if stocks are running low. Most drug development programs require the establishment of a succession of RS, starting with a development RS (DRS), followed, as clinical trials start, by an interim RS (IRS) and then, ready for license submission, a primary RS (PRS) and working RS (WRS).
Tech Briefing: Use of Design of Experiment (DOE) for Bioassay Development
Doing more with fewer resources is the name of the game in any business. One of the best tools for cutting through the early stages of assay development, when one doesn’t know what assay parameters are critical and which aren’t, is the use of a multifactorial design of experiments (DOE). DOE allows assessment of multiple factors rather than the traditional “one-factor-at-a-time” (OFAT) approach.
Tech Briefing: Reference Material (RM) For Determining Potency of Biopharmaceutical Products
Product Reference Material (RM) for determining potency of biopharmaceutical products is a critical manufacturing reagent. In a commercial environment a company allows their product RM to run out, newly manufactured product cannot be released. If an instability in the RM is discovered, not only can newly manufactured not be released, but all recently released batches using the unstable RM must be recalled.
Tech Briefing: Improved Clearance of High Risk HCPs
In this year’s BEBPA Host Cell Protein Conference, we are featuring presentations covering some recent successes downstream process engineers have had in in improving the purity of biopharmaceuticals.
Tech Briefing: Developing Potency Assays to Support Early Phase Clinical Studies
The International Conference of Harmonization (ICH) just finalized two guidance documents which discuss analytical methods in depth: Q2(R2) Validation of Analytical Procedures Guidance for Industry (Ref. 1) and Q14 Analytical Procedure Development Guidance for Industry (Ref. 2)
Tech Briefing: Pooling Industry-Wide Data for Determining Relevant HCPs
In the “early days” of BEBPA HCP Conferences, there always seemed to be at least one public request for companies to disclose information about HCPs in their products. My recollection is that these requests were always greeted with external nods of approval, but I think everyone was thinking internally, “Yeah, but what are the chances my company’s legal department is going to approve that.” In 2018 Vanderlaan et al. published a review article summarizing all clinical experiences with HCPs up to that time.[1] The case studies represented the major effects HCPs can have on product safety and efficacy: the adjuvant effect, cell line homologs of the product, immunogenic HCPs, cytokine HCPs, and HCPs that affect product stability. In recent years Regeneron published HCPs identified in 29 drug products,[2] and the BioPhorum Host Cell Protein Workstream Group published a list of common CHO HCPs reported in recombinant protein products.[3]
Tech Briefing: The Wonderful World of Potency Assays: Look at me now Ma!
The concept of potency assays came into being specifically for biopharmaceutical products. Originally these products were complex mixtures, produced in a natural system (Like a horse!). They were often ill-defined and rarely purified to any extent. Because of these characteristics, these products were defined as a manufacturing process. The mantra “the product is the process” was a well-known and guiding concept for regulation and oversight for decades. Vaccine products were some of these earliest approved biologicals.