Selecting the right biotechnology company is imperative in ensuring the quality of materials and a satisfying result. Alliance BioMed is the right choice for you. Well-versed in contract manufacturing, we have a laboratory that can put your medical devices to the test, along with being able to produce them for you.
Our contract development for PCR includes formulation and testing, filing, labelling, inspection, and shipping. We are committed to bringing your ideas to fruition. Thus, the best-suited choice for full-scale manufacturing and commercialisation.
But before we walk you through each step of our PCR Contract development, let’s look at why contract development is preferred.
Why should I go for contract development?
Engaging a contract developer can be cost-saving, as the business wouldn’t have to invest in equipment and facilities and staff members to begin this stage. Also, the contract developer can take on the role of an expert to conduct any testing through trial and error and note any modifications that need to be made. This will lead to an end product of greater quality and satisfaction.
If you would like more information, take a look at our write-up, which provides detailed explanations of the various benefits of contract development.
Now let’s take an in-depth look at each stage of our end-to-end contract manufacturing.
Stages of contract manufacturing that we provide.
Formulation and Testing
We will build your PCR assays and kits according to your specifications and recipes and accommodate special requests, such as additional filtration steps to remove particulates. These procedures will be performed in a clean room environment.
For kit components that contain templates (e.g.: positive controls), we can provide accurate dilution services to achieve your desired target copy number. Notably, preparation of components containing templates will be performed separately from the other reagents to prevent contamination.
In addition, we will advise on the quality control steps to be implemented and performed to ensure the manufacturing process. Finally, the final testing can be performed according to your Standard Operating Procedure. To avoid cross-contamination, the areas where the reagents are prepared, kitted and tested will be separate.
Our staff receives extensive training before being assigned to new projects to ensure excellence in process and quality control.
We will use various filling methods to meet your needs, either through automation or by hand.
Our experienced personnel handle your labels, including design, printing, and application. In the event of a label reconciliation, all unused labels will be accounted for and destroyed.
We perform inspections on all products before they leave for critical or non-critical defects.
Each stage of your product’s development is paramount and held to a high standard, which includes its shipping and packaging. We will store them in temperature-controlled areas, to ensure quality. Before shipping, the use of appropriate packaging materials will ensure their safety while transporting.
Where else to bring your ideas to life, if not a laboratory with Biosafety Level 2 facilities, and an ISO 13485 certification? With more than two years of experience in the field, we will truly be with you every step of the way.
Reach out to us through firstname.lastname@example.org, or +65 6865 5700 if you would like more information on PCR Contract Development.