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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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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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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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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.
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A New Reality In Life Sciences
Gain insight from this author's experience with virtual reality (VR) and the specific benefits of VR in scientific contexts.
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Big Risks Yield Great Rewards In Cell Therapy
George White, Cytiva’s GM of Product Management for Cell and Gene Therapy, provides insight into the latest developments and strategies in cell therapy and where this dynamic field is headed.
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Finding The Talent To Fuel Biopharma Breakthroughs
Explore findings from research into talent pool resilience in the biopharmaceutical industry that incorporate survey insights as well as external data to ensure a more accurate overview.
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Impact Of Glycosylation On The Effector Functions Of Monoclonal Antibodies
In an example using rituximab and its biosimilars, explore the significance of minor differences of glycosylation in antibodies and its impact on their properties and functionality.
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Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars
The presence of anti-drug antibodies (ADAs) can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.
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Metabolite And Nutrient Analysis As Crucial Components For Optimal Upstream Process
Discover how insights into cell metabolism can further enable the development of efficient cell culture processes through tailored nutrient supplementation and monitoring.
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Development And Regulation Of Veterinary Monoclonals
Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.
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The Latest Trends In The Prevention And Treatment Of Cervical Cancer
Unearth what immune checkpoint inhibitors are showing promise in treating cervical cancer and how advancements in these treatments paired with additional prevention strategies are improving patient outcomes.
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Novel Approaches For Obtaining High-productivity Clones
Let's dig into cell line selection approaches, transposons to increase copy number for the gene of interest, and targeted integration to rapidly obtain high-productivity clones.
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Lowering The Lipids Barrier: The Key To Accelerating RNA-LNP Drug Development
Learn about the drug development hurdles that must be overcome to deliver on the promise of mRNA.
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Getting CMC Right For Emerging Technologies
Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.
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Pacesetters Are Product Innovators Who Embrace Digital Process Enhancement
The Josh Bersin Company recently underwent research examining pharma/biotech “pacesetters” in the field. We caught up with Jordan Schmitting, senior research analyst at The Josh Bersin Company, to discuss the trends illuminated by the research.
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Following The Science To Develop Best-In-Class Cancer Drugs
As innovative cancer therapeutics continue to enter the clinical trial pipeline, some developers are shifting their focus toward developing drugs that are safe and efficacious with minimal toxicity.
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A Lean, Agile Business Model To Deliver High-Quality Oncologic Treatments
No two journeys through the drug pipeline are the same; the ability to leverage a variety of approaches for different products is what sets one lean biotech company apart.
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A Tale Of Two Brothers: The Abpro Founders
By founding their latest venture, Abpro, Ian and Eugene Chan are using their synergistic skillsets in business and medicine to rapidly generate antibodies that treat cancer and autoimmune diseases.
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Welcoming The “Era Of ADCs”
Dr. Loretta Itri sat down to explore the promise of TRODELVY®️ and other antibody-drug conjugates as transformative treatments for a range of malignancies and intractable diseases.
BIOSIMILAR DEVELOPMENT NEWS
- Biogen Receives Positive CHMP Opinion For TOFIDENCE™ (tocilizumab), A Biosimilar Referencing ROACTEMRA®
- Evernorth Announces Humira Biosimilar Available At $0 Out Of Pocket For Accredo Patients In June
- Alvotech Announces Topline Results From A Confirmatory Clinical Study For AVT05, A Proposed Biosimilar For Simponi® (golimumab)
- Samsung Bioepis Gains European Commission Approval For PYZCHIVA7™, A Biosimilar To Stelara (Ustekinumab)
- Sandoz Confirms European Commission Approval Of Pyzchiva (ustekinumab), Further Strengthening Immunology Offering
- Alvotech Signs U.S. Agreement To Expand Access For Newly Approved High-Concentration Interchangeable Biosimilar To Humira® (adalimumab)
- Alvotech And Teva Announce U.S. FDA Approval Of SELARSDI™ (ustekinumab-aekn), Biosimilar To Stelara® (ustekinumab)
- Fresenius Accelerates Momentum In Its (Bio)Pharma Business And Launches Tyenne, Its Third Approved Biosimilar In The U.S