Antibody Development

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Bio-Techne and USP Announce Collaboration to Accelerate Monoclonal Antibody and Gene Therapy Product Development
Prnewswire· 2025-06-24 11:00
Core Insights - Bio-Techne Corporation has entered into a distribution agreement with the U.S. Pharmacopeia (USP) to sell USP monoclonal antibody (mAb) and recombinant adeno-associated virus (AAV) reference standards, enhancing support for mAb and gene therapy development globally [1] - The need for consistent mAb quality is increasingly critical as patent protections expire and biosimilars emerge, necessitating rigorous testing of quality attributes during development and manufacturing [2] - Gene therapy, utilizing recombinant AAV, is rapidly growing but faces challenges such as low yields and high costs; USP reference standards provide benchmarks for analytical testing to ensure product quality [3] - USP mAbs and AAV reference standards can be used with Bio-Techne's analytical instruments, facilitating reliable characterization of complex biologics throughout the development process [4] - The collaboration between Bio-Techne and USP aims to address quality challenges in biotherapeutics, ensuring safety and efficacy for patient care [5] Company Overview - Bio-Techne Corporation is a global life sciences company that provides innovative tools and bioactive reagents for research and clinical diagnostics, generating approximately $1.2 billion in net sales in fiscal 2024 [6]
AnaptysBio (ANAB) FY Conference Transcript
2025-06-11 13:40
AnaptysBio (ANAB) FY Conference June 11, 2025 08:40 AM ET Speaker0 All right. Good morning. And it's my pleasure to introduce Dan Vega, President and CEO of Adaptive Bio as our next speaker. Dan, welcome. It's the time for me to host you at the Goldman Sachs Conference. Conference. So thank you for being here. Before we kick off with the Q and A, I'm going to turn it to you for a quick opening remark. Speaker1 Perfect. Well, thanks for having me here today. It's my pleasure to be here. We have a lot going o ...
AbCellera Biologics(ABCL) - 2024 Q4 - Earnings Call Transcript
2025-02-27 23:00
Financial Data and Key Metrics Changes - AbCellera reported a revenue of approximately $29 million for the year, a decrease from about $38 million in 2023, primarily due to a shift towards internal and co-development programs [23][24] - The company experienced a net loss of roughly $163 million for the year, compared to a loss of about $146 million the previous year, which included non-cash impairment charges for in-process R&D of approximately $47 million [24][25] - Cash and equivalents at year-end were over $650 million, with total available liquidity estimated at approximately $840 million, including committed government funding [18][27] Business Line Data and Key Metrics Changes - The company advanced two programs, ABCL-635 and ABCL-575, which are positioned for CTA filings in Q2 2025 [7][17] - AbCellera has a cumulative total of 96 partner-initiated programs with downstream participation, with 16 molecules having reached the clinic [19][20] - The internal pipeline has grown to 27 programs, up from 19 at the beginning of the year, indicating a focus on internal development [21][22] Market Data and Key Metrics Changes - The total addressable market for ABCL-635 is estimated at $2 billion in annual sales, while the market for atopic dermatitis, relevant to ABCL-575, exceeds $10 billion [10][12] - The company is focusing on oncology, neurology, and immunology, reflecting broader industry activity [21] Company Strategy and Development Direction - The company is transitioning from a platform and partnership model to a clinical-stage biotech, emphasizing internal pipeline development and clinical trials [6][17] - Strategic focus includes initiating Phase 1 clinical trials for lead programs, nominating additional development candidates, and completing platform investments [17] - The company aims to build a portfolio of wholly owned and co-owned drug development programs, assessing opportunities based on scientific conviction, unmet needs, differentiation, and development paths [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's liquidity and ability to fund operations for the next three years while advancing the pipeline [27] - The competitive landscape, particularly from China, is being monitored, but management believes their portfolio is robust against such dynamics [35] - The company is optimistic about the upcoming clinical trials and the potential for significant advancements in their drug development programs [60] Other Important Information - The company is reducing new discovery partnership activities while still seeking collaborations in specific areas, such as TCE platforms [16] - The new clinical manufacturing facility is expected to come online by the end of 2025, supporting the company's growth strategy [26] Q&A Session Summary Question: What competencies are needed for clinical trials across different disease areas? - Management highlighted the importance of building translational science and clinical development teams to support diverse programs, with hiring focused on development and clinical areas as programs progress [30][32] Question: What is the status of the AbbVie collaboration? - The collaboration with AbbVie is seen as a significant step forward, with a focus on a small number of targets and a commitment to advancing TCE science [34][48] Question: What is the attrition rate for partner-initiated programs? - Management indicated that details on attrition rates will be disclosed in future filings, with expectations of consistent progress among partnered programs [38][39] Question: Why reduce the number of partnerships? - The decision to transition to a clinical-stage biotech necessitated a focus on internal programs, while still seeking strategic partnerships that align with their objectives [40][41] Question: What preparations are being made for the upcoming CTA filings? - Preparations for the CTA filings for ABCL-635 and ABCL-575 have been extensive, with clinical teams and plans in place to ensure smooth execution [60]