Biotech & Pharma
LMS Issue 4 | 2014
19
Be Confident in your Results
F
or biopharmaceutical organisations
challenged to deploy high-resolution analytics across the innovative
biotherapeutic or biosimilar development process, Waters’ Biopharmaceutical Platform Solution with
UNIFI® integrates robust UPLC/MS
characterisation technology with comprehensive software for applications
in bioseparations, intact protein mass
analysis, peptide mapping and released
glycan analysis.
The platform enables a laboratory to
comprehensively acquire process and
report LC and MS characterisation
data throughout a biotherapeutic’s
development lifecycle. From bioseparations to LC/MS characterisation, the
Biopharmaceutical Platform Solution
provides detailed workflows that enable
results to be readily shared from discovery to development to GxP quality
control laboratories.
The platform increases confidence
in the results - confidence that one has
obtained the best results for development decisions, and confidence that
one has the information necessary to
address regulatory requirements.
At the heart of this platform is the
UNIFI Scientific Information System,
which is the first software to merge
LC and MS data in a single solution
that encompasses data processing, visualisation, and reporting and configurable compliance tools. The GlycoBase
database of glucose unit values is now
integrated as a library within UNIFI. The
platform supports a mix of quadrupole
time-of-flight MS and optical detection
instruments within a networked laboratory workgroup.
The ability to deploy UNIFI-based
systems within regulated or nonregulated laboratories provides companies the flexibility to employ high
resolution UPLC bioseparations and
high performance mass analysis. ⚛
Microsep
Contact: Louis van Huyssteen
Tel: 011-553‑2300
Email: [email protected]
Electrolab 14
T
he most effective and perfect tool
for R&D, QC and BE studies
is the Electrolab 14 place dissolution
tester. According to the South African
FDA regulations this tester should be
used so that there is no need to make
bio-availability studies again.
The dissolution tester includes temperature monitoring of all 14 vessels
with motorised driving manifold and
a tablet input device as an option. One
of the most advanced dissolution testers
for the pharmaceutical industry today, it
also facilitates online/offline automation.
Additional features include:
• Time saving tool for S1, S2, S3
• Complies with USP, IP, Ph. Eur.
specifications
• Supports USP I, USP II, USP V and
USP VI test methods
• 20 programmable protocols +