02.23.23 -- Cell & Gene Therapy Regulatory And Compliance Solutions

We address the additional compliance challenge in biopharma of the requirement of complex analytical instruments that are not traditionally used in highly regulated labs.

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

We have developed an innovative portfolio of affinity chromatography resins to help you solve challenges in the downstream process of next-generation antibody therapeutics. These resins are specifically designed for the purification of engineered monoclonal antibody (mAbs) modalities.

Biosafety testing and characterization for new products is essential as they emerge for clinical study. Both measures will help mitigate safety concerns and confirm product quality before these therapies are administered to patients. Our BioReliance AAV testing services give you the confidence to get your products to market quickly and safely.

Our cell therapy product characterization services combine rapid PCR, ELISA and custom methods tailored to these product types from a single contract partner with fully compliant cGMP facilities and options for research grade testing available.

Novotech’s medical and regulatory consulting team offers full range of pre-clinical, regulatory affairs support, medical and pharmacovigilance consulting services.

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.

Discover an e-training center that provides a digital training and continuous learning platform that can be accessed 24/7, by a large number of users, to accommodate biopharmaceutical training demand.

Germfree’s bioGO Modular Cleanrooms are available in multiple configurations to meet a wide variety of cGMP product development, production, and training applications.

A small biotech company engaged Veristat early in clinical development for help with a novel biologic being tested for treatment of an ultra-rare and aggressive hematologic malignancy with no available effective therapies. Discover what happens in this case study.

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.

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.

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.

You need to build the right infrastructure and capabilities into the clinical process to support your product’s commercialization.

We help you implement innovative approaches that help you achieve higher quality, increased reliability, faster project delivery, reduced energy and operating costs, and an integrated, business focused approach to regulatory compliance.

With leadership in immunogenicity, a regulatory team that coordinates therapeutic and companion diagnostic strategy, and a focus on executing end-to-end clinical trials in oncology and rare disease, Precision is positioned to guide successful gene therapy development.