Celltrion Inc.

Kemwell is a contract biologics development and CMO company providing services to global biopharmaceutical organizations. Kemwell facilities, located in Bangalore, India, are designed and developed with technological support from a leading German pharma company. Kemwell provides customers with cost-effective access to state-of-the-art technology for all mammalian cell culture based products’ development and manufacturing.

15,000 sq. m. Kemwell facility consists of a cGMP drug substance manufacturing area with over 4500L bioreactor capacity, sterile fill and finish areas for cGMP drug product manufacturing and process development laboratories to support production of protein therapeutics from mammalian-cell culture – monoclonal antibodies, bi-specific antibodies, fusion proteins, etc. Kemwell is capable of supporting novel, bio-better and biosimilar programs’ preclinical development, clinical development, cGMP clinical manufacturing and cGMP commercial manufacturing.

Kemwell, having established in 1980, had long term associations with pharma majors such as Bayer, GlaxoSmithKline, Merck KGaA, Novartis, Pfizer and others for small molecule contract mfg. and R&D. In 2016, Kemwell divested its small-molecule division to focus on biologics, leveraging its vast and rich experience. Kemwell is now a 100% biologics CDMO.

Custom Biologics provide exceptional, high quality, customized assays to measure the functional properties of cellular and biotherapeutic drug candidates. We are a Health Canada audited, GMP-compliant, global service provider for functional testing of biotherapeutics, biosimilars and antibody drug conjugates.

For over 14 years our scientists have been designing and validating sophisticated bioanalytical assays, to characterize and measure the therapeutic potential of large and small molecule biotherapeutics.

Our work supports regulatory drug submission applications from biopharmaceutical companies throughout North America, Europe and Asia.

Great Science - It's at the heart of everything we do!

Adipogen Life Sciences is a leading research reagents company with its corporate headquarters is in San Diego, USA and the Operational headquarters and production in Switzerland. A motivated team of highly-skilled individuals develops and manufactures new products for the Life Science Research Market in its main areas of interest including obesity & diabetes, immuno-oncology, inflammatory diseases, innate immunity (inflammasome) and antimicrobial resistance. A major focus is on innovative and advanced ELISA Kits. In addition to the antibody and protein facilities, Adipogen Life Sciences owns chemical laboratories, enabling the company to isolate unique natural products and to develop new and innovative small molecules and rare antibiotics.

Alomone Labs, your partner in ion channel research, is a leading supplier of Ion Channel, GPCR and Neural Signaling tools. We specialize in the production of primary antibodies, small molecules and proteins and peptides used in basic science research. Alomone was established in 1989 and has become the most comprehensive source of ion channel research tools used by scientists worldwide. All of Alomone`s products undergo bioassay validation and are supplied in lyophilized powder format so that you can be confident about their biological activity and long shelf life.

At Alturas Analytics, we deliver results on time with the highest level of integrity. Our business is built on developing long term collaborations with our clients by providing advanced MS/MS solutions through a focused emphasis on teamwork, communication and exceptional science.

Alturas has a proven record with complex analysis supporting drug candidates for the pharmaceutical and biotechnology industries, from discovery through phase IV clinical trials. The company operates in a GLP environment using validated operational processes in strict adherence to internal SOPs and applicable global regulations. Bioanalytical services routinely performed include the following:

• GC-MS/MS and LC-MS/MS bioanalysis – allows for the broadest range of chemical properties across a wide mass range
• GLP and non-GLP bioanalysis of large and small molecules in any matrix
• Quantitative Antibody Drug Conjugates (ADC) analysis
• Biomarker quantitation
• Protein binding estimations
• Dried Blood (DBS) and Matrix Spot (DMS) analysis (limited sample volume ex. pediatrics, CSF, tears)

Ensuring that a project is completed on time to a company's specifications demands clear lines of communication before, during, and after a study's completion. Clients have direct access to a team of professionals who understand the critical nature of the business. An Alturas Study Director is assigned to each client based on their working knowledge with compounds of similar chemical properties.

Comments & Feedback:
"Thanks. We owe a lot to Alturas for the great nonclinical and clinical bioanalytical support for the program. Happy 2013!"​
January 2013: Comment from a Sponsor after receiving FDA Approval.

“You solved all of our bioanalytical problems.”
Comment from a Sponsor after the Alturas Team was able to address technical difficulties.

"Five Stars. Would definitely use Alturas again for upcoming projects."​ Comment from a Sponsor in 2016.