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Is Your Lab Ready For A LIMS Implementation?
Deploying a laboratory information management system (LIMS) can boost your quality control lab's productivity, but how are you going about it? This article shares key steps and considerations for setting up your physical lab, controlling inventory, and more.
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Is Industry Ready To Take A Bite Out Of Obesity?
What are the clinical, economic, and policy considerations for a class of drugs offering a promising treatment for obesity, and how is the industry adapting to meet demand?
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New And Upcoming Trends In Immunodiagnostics
Explore the latest trends and cutting-edge technologies in immunodiagnostics that are transforming disease detection.
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When Measuring Filter Performance, Is Performance Absolute?
Learn why high-performing filters are inadequate for critical filtration processes and sterilizing-grade filters are necessary to effectively remove undesirable species, including bacteria and viruses.
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Optimizing Virus Filtration Validation
Explore guidance regarding the effective validation of a virus filtration process in the laboratory, including the fundamentals of viral filtration and an examination of relevant regulatory guidelines.
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Raman As A Quality Control Tool For Cell Culture Media Preparation
Explore study results demonstrating how Raman technology easily differentiates between media with similar compositions and detects potential preparation errors that other analysis methods might miss.
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Real-Time And In-Line Raman Spectroscopy For Glycan Quality Analysis
This study details the use of in-line Raman spectroscopy to monitor mAb glycan profiles within a production bioreactor, highlighting its potential for automation and customization.
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Fab Fragment Development And Manufacturing For Clinical Trials
Explore the outcomes of implementing an accelerated approach to process development and manufacturing for a project that was crucial for the future of Acticor Biotech and its therapeutic candidate.
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Revolutionizing Drug Discovery From "Undruggables" To AI
Explore four current trends in drug discovery, how each trend addresses some of the most crucial challenges in drug discovery, and the obstacles to their widespread adoption.
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The Growing Demand And Applications For HPLC
High-performance liquid chromatography offers more features compared to other analytical techniques, and the industry is finding more valuable ways to use it.
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Overcoming The Solubility Challenges Of Antibody-Drug Conjugates
Discover a chito-oligosaccharide that significantly improves the solubility of antibody-drug conjugates (ADCs) when included in the linker-payload construct.
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Efficacy Screening Of Antibody-Drug-Conjugates By Surface Plasmon Resonance
Rapid screening of ADC affinity using surface plasmon resonance provides preliminary efficacy data in comparing antigen binding affinity with selected linkers and payloads to the non-conjugated antibody.
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Establishing Commercial Manufacturing Services For ADCs
Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities.
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Quick Read: FDA's New Draft Guidance On Data Integrity For In Vivo BA/BE Studies
The FDA has released a draft guidance, Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. This article shares a concise summary. The FDA is accepting public comments through June 3.
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New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies
The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.
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Viral Vector Producer Cell Lines: Learning From mAbs
Learn how applying bioprocessing knowledge from the production of mAbs can accelerate the development of viral vector cell lines and improve efficiency in gene therapy manufacturing.
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Tips For Viral Vector Production
Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.
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2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies
Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.
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Top Challenges In Recombinant Protein Purification Process Development
Get insights from process developers working with recombinant proteins that cannot be purified with affinity chromatography.
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Three Key Considerations For Optimizing Process Development
When it comes to process development, timing, technology, and partners all merit careful consideration. Explore expert insights into these three crucial factors.
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Navigating Cell Therapy Process Development
Explore the main challenges and considerations inherent in cell therapy process development.
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Formulation Process And Analytical Development Capabilities
Explore process and analytical development capabilities that can help you advance your formulation to GMP Manufacturing.
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Advancing A LNP Formulation To Clinical And Commercial Manufacturing
Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.
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Building Biopharma Resilience In Developing Gene Therapies
Learn about the opportunities and challenges surrounding gene therapies, the importance of collaboration between biopharma startups and academia, difficulties with the talent pipeline, and more.
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Biopharmaceuticals: State Of The Industry
How are government policies, talent pools, and supply chain constraints affecting the state of the industry? Learn about the biopharma industry’s biggest strengths, greatest challenges, and much more.
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Biopharma Resilience: Mass Immunization Programs
Explore the challenges involved with mass immunization programs, what role government can play in facilitating vaccination programs, how technology is transforming the biopharma industry, and more.
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Process Development With “The End In Mind” For Startups
We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.
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2024 LIMS Trends
The laboratory information management system (LIMS) landscape in 2024 is a dynamic one, driven by accelerating advancements in technology and evolving industry needs. This article shares the four key trends.
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The Power Couple: CRISPR And Oligonucelotides
Drug design using CRISPR depends on long guide RNA (gRNA) sequences. Find out how this love match between long oligos and CRISPR works.
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Five Essentials For Accurate Oligonucleotide Chemistry
Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.
BIOSIMILAR DEVELOPMENT NEWS
- Sandoz Launches Biosimilar Pyzchiva® (ustekinumab) Across Europe, To Treat Chronic Inflammatory Diseases
- Kashiv BioSciences Announces Completion Of Enrollment For Phase III Clinical Trial Of ADL018, A Biosimilar Candidate To XOLAIR (Omalizumab)
- Bio-Thera Solutions Initiates Integrated Phase I / Phase III Clinical Trial For BAT3306, A Proposed Biosimilar Of Keytruda® (Pembrolizumab)
- Bio-Thera Solutions Announces Regulatory Filing Acceptance For BAT2206, A Proposed Biosimilar To Stelara® In The US And EU
- FDA Approves Samsung Bioepis' EPYSQLI® (eculizumab-aagh) As A Biosimilar To Soliris (eculizumab)
- STADA And Alvotech Launch Uzpruvo, The First Approved ustekinumab Biosimilar To Stelara, Across Europe
- Boehringer Ingelheim And GoodRx Announce Exclusive Patient Affordability Initiative For Adalimumab-adbm Injection, Boehringer's Biosimilar To Humira®
- Xbrane Provides Update On Its Development Portfolio