BPR: What new products or innovations is Abzena showcasing at BIO 2024 this year?
Abzena has recently launched our AbZelect and AbZelectPRO cell line development (CLD) platforms, to enable the rapid generation and selection of high-yielding mammalian cell lines for therapeutic protein and recombinant vaccine production.
Thiobridge is Abzena’s conjugation technology that makes use of the native interchain disulphide bonds of an antibody, or similar targeting protein, to conjugate an array of linker payloads.
BPR: How does Abzena stay ahead of industry trends and developments in the pharmaceutical sector?
Abzena is expanding its focus on product and process services to clients who wish to go to early-phase, first-in-human, clinical trials, to include services to support late-phase clinical trials as well as commercial launch and commercial supply. Our first PPQ runs are scheduled for early 2025 and late phase process execution soon after.
BPR: What challenges are Abzena currently facing in the pharmaceutical market, and how are you addressing them?
Abzena specializes in difficult-to-express proteins, monoclonal antibodies, and associated products including for example fusion proteins, bispecific ad bifunctional antibodies, and antibody fragments, as well as bioconjugated products including antibody-drug conjugates and antibody oligonucleotide conjugates to name a few. Our integrated end-to-end platforms provide the most efficient path to process and product development from gene to first-in-human clinical material to late phase, PPQ, and commercial launch.
BPR: What strategies does Abzena employ to ensure the quality and safety of its pharmaceutical products?
Abzena guiding principles in product and process design are deeply rooted in FDA’s risk-based approach and quality by design (QbD) introduced over two decades ago, acknowledging that quality should be built into the product and that testing alone can not be relied on to ensure product quality. Our key to success is our ability to apply systematically the tools of QbD, starting with a detailed knowledge and understanding of the target product quality attributes to defining, optimizing, and characterizing the process by a combination of scale down models and statistically informed DOE studies to process and analytical control strategies and PPQ batches.
BPR: Can you provide insights into any regulatory changes or compliance issues that are impacting Abzena?
New guidances of ICH Q14 / ICH Q2(r2) release are driving streamlined strategic approaches in analytical qualification/validation tactical offerings to allow for speed to market and refocused, vigorous analytical development.
ICH Q5A(r2) updates around risk based approach shifts in thinking for viral safety are allowing for enhanced emphasis on risk-based thinking in manufacturing process viral clearance studies, particularly in platform manufacturing campaigns.
BPR: Can Abzena discuss any plans for expansion or market growth in the pipeline?
Abzena is expanding its focus on product and process services to clients from early phase, first-in-human, clinical trials, to include services to support late phase clinical trials and as well as commercial launch and commercial supply. Our first PPQ runs and commercial process support activities are scheduled for early 2025.
BPR: What sets Abzena apart from competitors in the pharmaceutical industry, and what value do you offer to your customers?
Abzena specializes in difficult to express proteins, monoclonal antibodies and associated products including for example fusion proteins, bispecific ad bifunctional antibodies and antibody fragments, as well as bioconjugated products including antibody drug conjugates and antibody oligonucleotide conjugates to name a few. Our integrated end-to-end platforms provide the most efficient path to process and product development from gene to first-in-human clinical material to late phase, PPQ and commercial launch. Abzena’s use of single use, ready-to-use, technologies throughout the manufacturing process reduces costs and time to market while providing highest quality material fit for its intended use.