Newsletter | August 5, 2022

08.05.22 -- Cell & Gene Therapy Regulatory And Compliance Solutions

 
     
 
 
 
 
OsmoTECH PRO Multi-Sample Micro-Osmometer From Advanced Instruments
 

Designed to meet the high sample throughput, regulatory compliance (including 21 CFR part 11), and data management needs of busy bioprocessing and biomanufacturing labs, the OsmoTECH PRO Multi-Sample Micro-Osmometer combines ease-of-use with accurate and precise osmolality measurements for reliable and reproducible results.

 
 
 
 
 
 
CHO Platform Service Package: The Fast Track To IND
 

Our service package brings together cell line development (CLD) to accelerate your program and puts your molecule on the path to success.

 
 
 
 
 
 
Benzonase endonuclease Safety Plus Emprove Expert Brochure
 

With its new features, Benzonase endonuclease Safety Plus Emprove Expert is ideally suited for manufacturing of cell and gene therapy agents such as adeno associated and lenti viruses, oncolytic viruses, and viral vector vaccines.

 
 
 
 
 
 
Quality, Compliance, And Regulatory Services For Life Sciences
 

The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.

 
 
 
 
 
 
PRECISION ADVANCE SERVICES
 

PRECISION ADVANCE, a collection of interconnected services and complementary teams uniquely focuses on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring cell or gene therapies to market.

 
 
 
 
 
 
Pharmaceutical Commissioning, Qualification And Validation Services
 

Our industry-leading compliance subject matter experts combine their technical and operational expertise in the areas of design, construction, commissioning, qualification, and validation to produce fully operational and compliant commercial operations.

 
 
 
 
 
 
GMP Formulate And Fill System For Cell And Gene Therapy
 

This formulate and fill platform is designed to accurately formulate and aliquot media or buffer solutions using flexible pre-defined recipes in a GMP environment. The platform gives confidence to your process utilizing sterile, closed single-use sets which allow for operation in class C or D cleanrooms.

 
 
 
 
 
 
FectoVIR-AAV GMP - Polyplus
 

FectoVIR-AAV GMP ticks all the boxes to make each AAV-based gene therapy a success.

 
 
 
 
 
 
Palltronic Flowstar V Filter Integrity Test Instrument
 

The Palltronic Flowstar V integrity test instrument ensures accurate filter integrity testing with a further reduction in test time, full compliance with 21 CFR Part 11, advanced automation capabilities, and simplified network integration saving the user time while improving process efficiency.

 
 
 
 
 
 
Chronicle Software: Scaling For Needs In Cell Therapy
 

Get support for your team through visibility of process data, locally and across your manufacturing sites. Obtain greater oversight of day-to-day operations, receive text and email-alerts of equipment alarms, and produce electronic batch records.

 
 
 
 
 
 
     
 
Solutions
 
Manufacturing Execution Systems (MES) For Drug Manufacturing
 

A traditional MES is too complex. Our solution is disrupting the market with a modern, cloud-based alternative that is fast to deploy, simple to configure, easy to use, and cost-effective to roll out across all your lines and sites.