Bio Platforms
SPECIAL FEATURE - Solubility & Bioavailability: Utilizing Enabling Technologies
Contributor Cindy H. Dubin interviews several leading companies on how they are using innovative technologies, such as lipid nanoparticles to achieve a high drug loading, combining anti-solvent continuous crystallization with micro-mixing technology to control crystallization and reduce crystal size, and how a robotic capsule can improve bioavailability in the range of 47% to 78%.
MARKET LANDSCAPE - The Future of Cancer Care Post-Pandemic: What Doctors, Patients, and the Healthcare Industry at Large Should Expect
Angelos Stergiou, PhD, explains how the COVID-19 pandemic saw failures in the healthcare delivery system not only in general medicine, but also specifically in oncology. At the same time, several opportunities came to light during such a difficult, frightening moment, bringing a number of large- and small-scale innovations forth.
GENE EDITING TECHNOLOGY - Harnessing a Cell’s Natural DNA Repair Process to Develop Medicines With Higher Levels of Precision & Durability
Mariana Nacht, PhD, reviews a new gene editing approach that harnesses a cell’s natural DNA repair process, known as homologous recombination, to insert a corrective copy of the gene (or transgene) at a precise spot in a patient’s genome.
eBOOK: Antibody Production
Antibody production is a multi-step complex process and generating reproducible antibodies is highly critical for immunoassays-based research, immunodiagnostics, and immunotherapy. Antibodies’ reproducibility is driven by…
EXOSOMES - The Next Evolution in Therapy Delivery Beyond the Cell Membrane: The Promise of Exosomes
Linda Marbán, PhD, says perhaps the best way to get past the cell membrane is to deliver contents the same way that cells send information to each other. And that is by the exosome, which in the case of targeted therapy delivery, has been identified as an alternative that shows powerful promise.
EXECUTIVE INTERVIEW - GATC Health & Liquid Biosciences: Faster, Cheaper, More Effective Drug Discovery
Ian Jenkins, Director of Science, and Jeff Moses, CMO at GATC Health, discuss the combined benefits of their MAT platform and Liquid Biosciences’ Emerge mathematical evolution platform to help identify the right biology sooner and focus on a smaller set of potential compounds early in the pre-clinical development process to enable pharma companies to develop drugs with more efficiency and a higher success rate.
GALECTIN INHIBITORS - Is a Galectin-3 Inhibitor the Answer for Millions of Patients With Cirrhosis & Cancer?
Pol F. Boudes, MD, explains how development of a galectin-3 inhibitor could play a significant role in treating liver diseases, such as non-alcoholic steatohepatitis (NASH) and its complication, liver cirrhosis.
BIOMARKERS - Biomarkers: The Guiding Light for R&D in Heterogeneous Diseases
Thomas Turi, PhD, says while biomarkers have been a long-standing part of R&D and a mainstay of clinical practice for the characterization and diagnosis of disease for decades, they are increasingly playing a crucial role in guiding decisions to improve efficacy and efficiency of clinical trials.
2022 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
APTAMER TECHNOLOGY - From Postal Codes to GPS: Building Better Drug Conjugates With Aptamers
David Bunka, PhD, and Emily Robinson, PhD, focus on a new breed of affinity binders that can be used as an alternative to antibody therapeutics and has the potential to reshape the industry, delivering new medicines with improved safety and efficacy profiles and reduced healthcare costs.
EXCLUSIVE ONLINE CONTENT
Cellares & Bristol Myers Squibb Announce $380-M Worldwide Capacity Reservation & Supply Agreement
Cellares, the world’s first Integrated Development and Manufacturing Organization (IDMO), will allocate multiple Cell Shuttles and its fully automated, high-throughput Cell Q systems across its IDMO Smart Factories in the US, EU, and Japan for Bristol Myers Squibb’s use ….
Neurolentech Signs Technology Access Partnership With Kaerus Bioscience
Kaerus Bioscience will access Neurolentech’s NDD Drug Discovery Platform to support development of its preclinical asset pipeline for numerous genetic syndromes….
Palisade Bio Enters Strategic Collaboration With Strand Life Sciences to Advance Precision Medicine Approach
Partnership marks a significant value-driving milestone in Palisade Bio’s mission to redefine UC treatment through targeted interventions based on PDE4-related biomarkers….
Evaxion Announces Phase 2 Clinical Trial Update: First Patient Completed Dosing With Personalized Cancer Vaccine
Significant Phase 2 clinical trial progress obtained with first patient finalizing EVX-01 vaccine dosing….
Voyager Therapeutics Announces Selection of Development Candidate for GBA1 Program in Collaboration With Neurocrine Biosciences, Triggering Milestone Payment
Voyager Therapeutics, Inc. recently announced the joint steering committee with its collaborator Neurocrine Biosciences has selected a lead development candidate in the GBA1 gene therapy program for the potential treatment of Parkinson’s disease….
WEBINARS
On-Demand Webinar: How to Safely Handle Your Antibody Drug Conjugate
Antibody Drug Conjugates (ADCs) have a highly specific mechanism of action which is an advantage for the treatment of several oncology indications…..
WHITE PAPERS
WHITEPAPER - Use of a Platform Formulation Technology to De-Risk Solid-State Variation in Drug Development
This white paper describes use of mesoporous silica as a porous carrier formulation technology to stabilize unstable polymorphs and to optimize solid state properties.
WHITEPAPER - Long-Acting Injectable Nanoparticle Formulations
Long acting injectable (LAI) formulations have been the subject of continued interest in the recent past due, in part, to their longer systemic circulation requiring less frequent dosing of drugs.
WHITEPAPER - PLGA Nanoparticles - Bridging the Gap From R&D to GMP
Poly(lactic-co-glycolic acid) (PLGA) has emerged as a promising material for drug delivery and biomedical applications. Its exceptional biocompatibility, customizable degradation and release properties, and versatility have led to….
APPLICATION NOTE: Process Optimization & Preclinical Production Using the ANP System
Particle Works is thrilled to announce the launch of a new Application Note that delves into the advancement of nanoparticles as carriers for targeted drug delivery. Developing nanoparticles for this purpose can be….
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.
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).