Bio Platforms
WHITEPAPER - Improve Process Economics & Enable High Protein Concentrations
What if you could achieve higher protein concentrations during downstream processing? This whitepaper spotlights how excipient combinations can enhance manufacturability and final concentration of mAb formulations.
Atavistik Bio Announces Publication Describing Foundational Technology for its AMPS Platform
Atavistik Bio recently announced a new publication in the journal Science by Atavistik Bio co-founder Jared Rutter, PhD, describing the foundational technology upon which the…
Catalent Expands UpTempo AAV Platform to Accelerate Development of Gene Therapies
Catalent recently announced the expansion of its UpTempo platform process for the development and CGMP manufacturing of adeno-associated viral (AAV) vectors. The platform now includes an…
Sermonix Pharmaceuticals Announces Initiation of Phase 3 ELAINE-3 Study of Lasofoxifene Plus Abemaciclib
Sermonix Pharmaceuticals Inc. and Guardant Health, Inc. recently announced the initiation of a registrational Phase 3 clinical study comparing targeted lasofoxifene in combination with the…
QSAM Biosciences Receives FDA Clearance to Expand Enrollment Criteria in its Phase 1 Study Targeting Metastatic Bone Cancer
QSAM Biosciences Inc. recently announced US FDA has cleared the Company’s amended clinical trial protocol increasing the maximum age of participants to 75 years old…
Indaptus Therapeutics Doses First Subject in its Ongoing Phase 1 Open Label Clinical Trial of Decoy20 in Patients With Advanced Solid Tumors
Indaptus Therapeutics, Inc. recently announced the dosing of the first subject in INDP-D101, the company’s first-in-human, open label, dose escalation and expansion, multicenter Phase 1…
BioStem Technologies to Acquire Majority of Assets of Auxocell Laboratories, Inc.
BioStem Technologies Inc. recently announced it has entered into an agreement to acquire the majority of the assets of Auxocell Laboratories, Inc., a leading solid tissue processing equipment manufacturer…..
Dyadic Provides Phase 1 Clinical Trial Update for its COVID-19 Recombinant Protein RBD Booster Vaccine Candidate
Dyadic International, Inc. recently provided an update regarding its Phase 1 Clinical Trial for its DYAI-100 COVID-19 recombinant protein receptor binding domain (RBD) booster vaccine…
WHITEPAPER - Purity is Paramount: Assessing N-Oxide Impurities in Lipids Used in Lipid Nanoparticle Delivery Systems
This study demonstrates that Evonik is capable of manufacturing high-quality lipids with a purity greater than 99% and a consistently low level of the N-Oxide impurity.
TCR² Therapeutics & Adaptimmune Announce Strategic Combination to Create a Preeminent Cell Therapy Company for Solid Tumors
TCR² Therapeutics Inc. and Adaptimmune Therapeutics recently announced entry into a definitive agreement under which Adaptimmune will combine with TCR² in an all-stock transaction to create a preeminent cell therapy company….
New Data Show CNM-Au8 Preserved ALS Patient Function & Slowed Disease Progression in the Open-Label Extension of the Phase 2 RESCUE-ALS Trial
Clene Inc. and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, recently announced new results showing preserved ALS….
NeOnc Technologies Engages Anova Enterprises to Pursue Pediatric Brain Tumor Indication & FDA Fast-Track Status
NeOnc Technologies Holdings, Inc. has recently expanded its engagement of Anova Enterprises to pursue a pediatric indication for NEO100, an enhanced method of delivering pharma-based…
Sermonix’s Lasofoxifene Improves Vaginal/Vulvar Symptoms Relative to Fulvestrant in ELAINE 1 Study of Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2- Breast Cancer and an ESR1 Mutation
Sermonix Pharmaceuticals Inc. recently announced that its lead drug candidate, lasofoxifene, improved vaginal/vulvar symptoms while fulvestrant worsened them in a study of postmenopausal women with locally…
Anti-Properdin Antibody Demonstrates Efficacy in a Primate Model of Wet-AMD & Dry-AMD
NovelMed Therapeutics recently announced NM3086, the lead clinical asset in its Properdin-associated Alternative Pathway (AP) program, demonstrated favorable efficacy in an animal model of neovascular…
Checkpoint Therapeutics Announces FDA Filing Acceptance of BLA for Cosibelimab in Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
Checkpoint Therapeutics, Inc. recently announced the US FDA has accepted for filing the Biologics License Application (BLA) for cosibelimab, Checkpoint’s investigational anti-PD-L1 antibody….
Avenue Therapeutics Enters Transformational License Agreement With AnnJi Pharmaceutical
Avenue Therapeutics, Inc. recently announced it has entered into an exclusive license agreement with AnnJi Pharmaceutical Co., Ltd. for AJ201, a first-in-class clinical asset currently…
SiSaf & the University of Leipzig Partner to Develop Bio-Courier Targeted miRNA for the Treatment of Pancreatic Cancer
SiSaf Ltd recently announced its collaboration with the University of Leipzig, Germany, to develop Bio-Courier targeted micro interfering RNAs (miRNA) for the treatment of….
EPO Decision to Grant European Patent for Rencofilstat Further Strengthens Hepion’s Patent Portfolio
Hepion Pharmaceuticals, Inc. recently announced the European Patent Office (EPO) has granted European Patent No. EP 3886813, covering the innovative formulation of Hepion’s lead cyclophilin…
SPECIAL FEATURE - Solubility & Bioavailability: Difficult Beasts to Tame
Contributor Cindy H. Dubin highlights the services many of these outsourced providers offer to enhance solubility and bioavailability and get their clients’ projects to market faster and cost effectively – while maintaining critical quality attributes.
EXECUTIVE INTERVIEW - Purple Biotech Ltd.: Developing First-In-Class Oncology Therapies
Gil Efron, Chief Executive Officer of Purple Biotech, discusses the company’s focus on identifying and developing promising molecules that may offer first-in-class approaches to treating devastating cancers with large unmet medical needs.
What are Bio Platforms?
Platforms (or asset-independent technologies to capture all kinds of capabilities that can be leveraged across many different drug candidate assets rather than just discovery tools that the term ‘platform’ immediately brings to mind) are ubiquitous in modern pharma. They are the product of an arms race, to secure access to the best capabilities in key areas.
Platform technologies are considered a valuable tool to improve efficiency and quality in drug product development. The basic idea is that a platform, in combination with a risk-based approach, is the most systematic method to leverage prior knowledge for a given new molecule. Furthermore, such a platform enables a continuous improvement by adding data for every new molecule developed by this approach, increasing the robustness of the platform.
But it has often been said that access to the latest technological platforms to aid efficient drug discovery and development is limited to Big Pharma, which can more easily justify the costs of creating and operating these platforms.
Benefits of Bio Platforms
Platform technologies have the ability to radically improve upon current products and generate completely novel products. In this sense, they open up new arenas for drug discovery and development, potentially increasing the number of therapeutic options for patients. Once a single compound or therapeutic has been generated and demonstrates a clinical benefit in patients, it is more likely this platform technology can successfully be applied to other therapeutic areas, derisking future compounds/products.
Complex drugs by their very nature are challenging and costly to manufacture. This, in turn, translates into higher costs for patients and other payers. In order to provide safe and effective therapies at a reasonable price, it is necessary for the industry to develop manufacturing technologies that reduce costs and provide a consistent product. While the initial investment may be larger, manufacturing costs will be lower over time as the manufacturing process is solidified.
Scale and Investment of Bio Platforms
Despite the initial upfront costs, platform technologies inevitably provide pragmatic solutions to production challenges, while yielding safer and more effective therapeutic products. It has often been said that one of the key features that distinguishes “Big Pharma” from biotech is access to the latest technological platforms to aid efficient drug discovery and development.
These platforms range from vast chemical libraries, ultra-high throughput screening and huge genetic databases in discovery, to predictive toxicology platforms, cutting-edge ‘omics’ and even deep-seated knowledge of particular therapeutic areas in development. All these platforms have two things in common: They can be used on any (or many) development candidate assets, and they cost huge sums to establish in the first place, and in a few cases each time they are used as well. Hence their restriction to the largest pharmaceutical companies (and a few of the so-called “big biotechs” that are, in many ways, indistinguishable from the old-guard pharma).
Only when you have hundreds of active projects can you justify the cost of creating and operating these platforms. Or so the mantra goes. It is access to these platforms that keeps the big companies ahead in the race to discover and develop the best medicines (or at least counterbalance the disadvantages of being large and slow-moving, depending on your point of view). But is that just an assertion? How much evidence is there to support the proposition that the efficiency gains due to these platforms outstrips the cost of creating and maintaining them?
Keeping these technologies “cutting edge” has become so expensive that increasingly we hear pharma companies talking of “pre-competitive” approaches to develop the next generation. A group of companies might develop a platform capability they then share. The principle goal of such initiatives is to access even grander and more expensive tools than individual companies could afford, rather than to dramatically cut costs (although sharing platforms rather than developing the same thing in parallel in each silo should at least keep a lid on rising costs).