Biological
Testing Services
Haemtech Biopharma’s stability and release
testing programs support your product and your company from early
evaluation of active pharmaceutical ingredients through stability
and release of your commercial drug product.
What We Do
Testing programs
Haemtech Biopharma offers stability and release testing services for
your biopharmaceutical, IVD or research product with a focus on
proteinaceous substances. Real
time, accelerated and long-term stability assessment programs are
offered as are shelf life testing and determination.
Regarding methodology we can conduct studies using
client-defined methods, compendial methods, or methods that we
design, develop and validate specifically for you.
We provide stability storage that meets ICH guidelines for a
variety of temperatures and humidity levels.
Analysis
In the course of your study we can evaluate your samples for a
number of characteristics or properties at pre-defined time points.
Potency, purity, and quality can be evaluated using a number
of techniques including activity assays, HPLC, moisture
determination, osmolality, and SDS-PAGE.
Data management
All data is generated on qualified equipment
using validated software, and is reviewed by our professionally
trained QA and QC staff. Data
is guaranteed to be accurate and traceable.
Results and essential data will be presented to you in
electronic format via a private and secure FTP site.
How We Do It
Personnel
The Haemtech staff that handles your project will consist of Ph.D.
biochemists and technicians with years of analytical experience with
biotherapeutics and other proteinaceous products.
Each member of our analytical team has been trained in GxP
methods, and will have the experience necessary to handle your
specific project.
The Service Proposal
Our staff will consult with you to identify the scope and needs of
your project. We will
work through scenarios with you that achieve your goals based on
your deadline. Finally,
you will be presented with a clear, easy to understand proposal
complete with costs and timeline.
Sample
Management
Samples are stringently reconciled against documentation
provided by the customer. Any
deviation between the samples and the documentation results in
immediate sample quarantine until clarification is obtained from the
customer. All customer
property is then maintained to protect against damage and
contamination and to allow for appropriate tracking and usage.
Safe and Secure
You can rest assured that your samples and data are in good hands
for the duration of your study.
Our safety program begins with our environmental monitoring
system, which monitors all storage chambers and freezers where your
samples are stored. Temperature
data is sent to a central server where it can be used to generate
temperature charts. In
the rare chance that a storage device does go out of specification
audible alarms alert on-site staff, and a call out system telephones
a chain of individuals trained in making sure your samples stay in
specification. Back up
storage devices are also in place in the event of a failure.
Should the power go out a back-up generator is activated
creating virtually seamless interruption in storage device function.
Your data is similarly secured on multiple on-site servers
that are maintained in a controlled environment, and with weekly
off-site, secure storage of tape back-ups.
Compliance
Haemtech
is an ISO 9001:2000 certified company that can perform services to
different degrees of regulatory compliance. Projects can be
done to meet cGMP, cGLP, or cGCP requirements and ICH guidelines.
We will implement specific USP and EP compliant methods when
required.
