In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|March 5, 2018
Packaged LIMS Solutions
Author(s)BioPharm International Editors
LabVantage offers laboratory information management system solutions that include additional industry-specific functionalities.
Advertisement
LabVantage, a provider of laboratory informatics solutions and services, offers packaged laboratory information management system (LIMS) solutions with additional industry-specific functionalities that are user friendly and adaptable, as stated by the company.
According to the company, all LabVantage LIMS systems share certain core configurations needed by most labs, but the specific capabilities of the company’s packaged solutions extend past basic system requirements and include software, services, and training delivered at a set price. Services include master data creation and site process mapping.
Specific “accelerated” capabilities include user requirement documentation, a pre-configured LIMS that meets a target lab's business needs, and a set of packaged services and training to deploy the LIMS quickly. Some of the packaged solutions also include additional deliverables, including industry-specific master data and fully executed validation documentation, according to the company.
The Pharma package, intended for labs that require validation based on the fifth version of the Good Automated Manufacturing Practice guide, provides complete pre-executed validation to match the delivered LIMS and includes United States Pharmacopeia master data method templates.
These solutions, including the Pharma package, were highlighted at Pittcon 2018 from February 26-March 1, in Orlando, FL.
Source:
Advertisement
Related to this article
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
Detalimogene voraplasmid produced a 56% complete response rate in BCG-unresponsive bladder cancer, with an estimated 43% of responses lasting a year.
FDA has cleared Biolojic Design’s IND for BD200, a bispecific antibody-drug conjugate targeting Trop2 and Nectin-4 whose arms can each bind either target. A global Phase 1 study in solid tumors is expected to begin in the coming weeks.
Blackstone Life Sciences will fund up to $1.5 billion of development costs through 2028 for Pfizer’s monthly GLP-1 receptor agonist berobenatide, in exchange for milestone payments tied to approval and sales. Pfizer keeps full control of the program.
Gene-corrected nula-cel freed all 3 RESTORE patients from transfusions, with sickle hemoglobin below 20% in the 2 followed for over 6 months.
Beam Therapeutics’ base-edited cell therapy risto-cel meets its primary endpoint in the BEACON sickle cell disease trial, Amgen’s CD40L antagonist dazodalibep reduces systemic disease activity in the phase 3 OASIZ-301 Sjögren’s disease trial, and ImvivaBio’s allogeneic CD19/BCMA CAR-T CTA313 sustains lupus remission through 12 months.
Matt Truppo, Richard Jaenisch, and Brian Drapeau examine AI's impact on drug success, human oversight, data governance, and biopharma's future.
Advertisement
Advertisement
Trending on BioPharm International
1
ImvivaBio’s Dual-Target Allogeneic CAR-T Sustains Lupus Remission Through 12 Months
2
Updates on Simtra BioPharma Solutions’ Bloomington Capacity Expansions
3
Blackstone to Provide Pfizer Up to $1.5 Billion for Monthly GLP-1 Berobenatide Development
4
Beam's Risto-cel Meets Primary Endpoint in Sickle Cell Trial
5