Broad Institute

MAY 14, 2024

William Studier for development of widely used protein- and RNA-production platform By Corie Lok May 14, 2024 Breadcrumb Home Merkin Prize in Biomedical Technology awarded to F. William Studier developed the T7 expression technology at Brookhaven National Laboratory. Credit: Brookhaven National Laboratory.

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RNA Production Molecular Biology Laboratories 84

Drug Target Review

JANUARY 26, 2024

Researchers from Columbia University and the US Department of Energy (DOE)’s Brookhaven National Laboratory have elucidated a method to produce large quantities of the receptor that the SARS-CoV-2 spike protein uses to bind to the surface of human cells. This study was published in Virology. Reference 1 Fan S, Ge J, Lan J, et al.

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Production DNA Virus Protein Expression 114

Conversations in Drug Development Trends

JANUARY 21, 2025

Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. What is one contributing factor that sets the 20% that do apart from the rest?

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Clinical Trials Laboratories Trials Drug Development 78

Agency IQ

MAY 28, 2024

BY RACHEL COE, MSC The House E&C Health Subcommittee Hearing on May 22 featured an extensive grilling of the leaders of FDA’s three medical products centers: CDER, CBER and CDRH. Fill out the form to read the full article.

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Production FDA Laboratories 59

Agency IQ

APRIL 12, 2024

BY RACHEL COE, MSC Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. As defined in statute, the FDA uses the term “potency” to refer to the “specific ability or capability” of a product to “effect a given result.”

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Production Laboratories FDA Regulations 59

PPD

OCTOBER 18, 2023

1 With this growth comes increased demands for laboratory services at all steps across the development process. Access to a laboratory partner that already possesses the equipment, knowledge and personnel can save time and money. Stay ahead of the curve with a great GMP/CMC contract laboratory partner.

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Laboratories Assay Development Small Molecule Drug Development 52

The Connected Lab

MAY 4, 2022

Connected digital technologies and advanced analytics are revolutionizing chromatography and mass spectrometry (CMS) workflows , enabling more efficient and productive ways of working. Here, we look at how ongoing advances in laboratory informatics solutions will help organizations ease the path to this future landscape.

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Laboratory Informatics Laboratories Pharmaceutical Companies Pharmaceuticals 52

Precision for Medicine

APRIL 7, 2023

The custom-designed laboratory accommodates the growth in demand for advanced digital pathology and imaging capabilities, expertise in molecular sciences and a wide array of sequencing technologies. The expansion significantly increases the sample processing capacity of the laboratory. Senior Vice President at Precision for Medicine.

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Laboratories Clinical Research Clinical Trials Cell Biology 52

Conversations in Drug Development Trends

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. Modifying and expanding the cells in a GMP laboratory. These advanced therapeutics harness the power of molecular biology to improve human health.

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Therapies Clinical Supply Clinical Trials Trials 72

sptlabtech

JANUARY 15, 2024

Laboratories globally rely on firefly for its liquid handling precision. firefly: More than a tool, a laboratory partner firefly isn't just another piece of lab equipment; it's a dynamic partner in scientific research. By working with reliance, our customers can safeguard their investment and achieve sustained productivity.

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Engineering Laboratories Production Research 103

Alta Sciences

JULY 11, 2023

VIRTUAL TOUR: Discover our In-House R&D and Formulation Laboratories tchichekian Tue, 07/11/2023 - 17:49 HTML Enhance Your Outcomes With Our Analytical Services Altasciences’ in-house R&D and formulation laboratories offer an extensive array of analytical solutions to support sponsors’ drug development and manufacturing programs.

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Laboratories Packaging Drug Development Production 40

Drug Target Review

APRIL 17, 2024

HLA-II presents peptides to CD4 T cells thought to be important for indirectly helping immune responses and facilitating antibody production. Dr Chowell spent a year as a visiting graduate student at the Moe Win Laboratory for Information and Decision Systems at MIT.

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Immune Response Laboratories DNA Virus 105

SCIENMAG: Medicine & Health

JUNE 26, 2023

Chicago, Illinois (Embargoed until 9:30 am CDT, June 26, 2023)—Cathy Sue Cutler, PhD, FSNMMI, director of the medical isotope research and production program at Brookhaven National Laboratory in Upton, New York, has been named as president-elect for the Society of Nuclear Medicine and Molecular Imaging (SNMMI).

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Laboratories Production Research 85

Alta Sciences

NOVEMBER 4, 2024

The Challenge: Safe Manufacture of Highly Potent APIs Exposure to highly potent APIs must be carefully managed during production. Known to be a reproductive toxin and harmful to aquatic life, it required careful containment measures during production.

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Engineering Production Compliance Laboratories 52

FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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Laboratories FDA Regulations Licensing 81

thought leadership

SEPTEMBER 7, 2023

Developing in vitro diagnostic tests, laboratory-developed tests, medical devices, or therapeutics is complex and requires careful consideration of various factors. In this blog post, we will explore the value of market access analysis and its role in the development of medical products.

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Marketing Production Laboratories Science 40

sptlabtech

JUNE 9, 2023

However, with so many individual processes involved in NGS library preparation, you might think that automating this workflow requires several instruments costing large amounts of laboratory space. Enter firefly ®. What benefits can you expect to see from making the switch to automated liquid handling with firefly?

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Laboratories Molecular Biology DNA Engineering 98

FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

FDA noted that because the scope of ISO 13485’s complaint handling requirements are “substantially similar to the QS Regulation for complaints”, FDA believes that laboratories that satisfy the current QSR complaint requirements “will meet the amended QS Regulation requirements” for complaints.

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FDA Laboratories Regulations Compliance 64

Codon

JULY 14, 2024

receives a blood transfusion or a blood product every two seconds. But currently, traditional blood transfusions face significant challenges, including a dwindling pool of donors and a limited shelf life for stored blood products. Karl Landsteiner in his New York laboratory.

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Production Clinical Trials Trials Therapies 140

FDA Law Blog: Biosimilars

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 1] However, the focus of CLIA requirements is on laboratory processes, not specific assays.

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Compliance Laboratories FDA Regulations 64

Agency IQ

JULY 26, 2024

reference laboratories for high-risk diagnostics The newly available May 2024 meetings of the Medical Device Coordination Group provide insight into the European Commission’s efforts to fully implement the European medical device and diagnostic regulations. Reference Laboratories: E.U. Top IVDR Notified Body concern: Lack of E.U.

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Laboratories Regulations Virus Production 40

Drug Target Review

DECEMBER 11, 2024

Our approach, grounded in Good Laboratory Practice (GLP) and honed through thousands of studies, ensures that even the most subtle toxicological indicators are reliably detected. Purity and radioactive enrichment are key factors in ensuring the IS aligns with product specifications.

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International Laboratories Drugs Pharmacokinetics 52

DrugBank

MARCH 28, 2024

Their focus spans a wide range of potential solutions, from drug repurposing to the creation of nutrient-dense products tailored to counteract the omics-level changes.  Vector Space Biosciences is pioneering this effort by devising countermeasures against the detrimental impacts of space travel on human physiology.

DNA 144

DNA Laboratories Disease Engineering 144

BMG Labtech

DECEMBER 20, 2024

6 It provides the energy needed to support cell division, synthesize necessary macromolecules, make use of nutrients, manage waste products, and adapt to environmental conditions. No substrate can be converted to a metabolic product if no active enzyme is available to metabolize that substrate. Why measure bacterial metabolism?

Regulations 52

Regulations Laboratories Research Production 52

Drug Target Review

JULY 5, 2023

A good introduction to the use of CHO cells for biotherapeutics production can be found in an article commemorating the 20th anniversary of the approval of a product produced using CHO cells. However, some groups will decide to complete this stage within their own laboratories.

Engineering 105

Engineering DNA Laboratories Production 105

Drug Target Review

JULY 24, 2023

In addition, we have concluded that the gene product is an apicpolast RNA polymerase sigma factor because of the localisation of the gene product, ApSIGMA, in the apicoplast interaction with apicoplast promoter DNA sequences, and the activity of an ApSIGMA- E.coli _RpoS chimeric sigma factor protein.

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RNA Regulations Bioinformatics Laboratories 98

Fierce BioTech

JULY 18, 2024

Efficient-Pro Medium and Feed 1 enable rapid and seamless upstream process development and scale-up for CHO-K1 cells Download the white paper to learn how this innovative solution can help optimize your mAb production processes.

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Laboratories Production 52

FDA Law Blog: Biosimilars

OCTOBER 6, 2023

Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. By Allyson B. Mullen & Gail H.

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Laboratories FDA Regulations Production 64

FDA Law Blog: Drug Discovery

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

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FDA Production Drugs Laboratories 108

ASPET

MARCH 20, 2024

Our laboratory previously demonstrated reduced levels of TOP2β/180 (and the paralog TOP2α/170) in an acquired etoposide-resistant K562 clonal cell line, K/VP.5 TOP2β/180 can be a target for DNA damage-stabilizing anticancer drugs, whose efficacy is often limited by chemoresistance.

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DNA Laboratories Therapies Regulations 100

Agency IQ

JULY 22, 2024

BY LAURA DIANGELO, MPH In April 2024, the FDA issued a final rule to update its regulatory approach to certain test products known as Laboratory Developed Tests (LDTs).

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FDA Laboratories Regulations Drug Development 59

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 3] FDA further assumes that these laboratories collectively perform roughly 80,000 LDTs.

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FDA Laboratories Regulations Production 69

Quanticate

JUNE 13, 2024

When relying on clinical research to introduce new products to the market, adhering to regulations like Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and CFR Part 11 is mandatory. All trials must comply with country-specific regulations set by regulatory bodies.

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Clinical Trials Laboratories Regulations Clinical Research 59

DS in Pharmatics

JANUARY 6, 2025

In the pharmaceutical industry, the successful transition of a drug substance from the controlled environment of the laboratory to large-scale production at a manufacturing plant is critical.

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Compliance Laboratories Drugs Pharmaceuticals 52

FDA Law Blog: Biosimilars

OCTOBER 30, 2023

Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals, 88 Fed. Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Clandestine Production of Controlled Substances or Listed Chemicals, 64 Fed. 73,044 (Oct.

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Laboratories Production Regulations Drugs 59

FDA Law Blog: Biosimilars

JUNE 26, 2023

Houck — The Drug Enforcement Administration (“DEA”) has designated precursor chemicals, including 4-piperidone just last month, used in the illicit manufacture of controlled substances as List I and II chemicals over the years as “laboratory supplies,” but has never revised or updated its Special Surveillance List. 21 U.S.C. § 21 U.S.C. §

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Laboratories Production International Drugs 53

Drug Target Review

NOVEMBER 1, 2023

ATX is mainly involved in phospholipidic metabolism and the production of extracellular lysophosphatidic acid (LPA) from lysophosphatidylcholine (LPC). Recently, our laboratory discovered a potent partial inhibition of ATX by cannabinoids in a nanomolar range. Cancer Metastasis Rev. 2018 Sep;37(2–3):509–18. The Journal of Cell Biology.

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Clinical Trials Trials Small Molecule Disease 134