From development to commercial supply we offer pragmatic, flexible and time-saving solutions for biopharmaceutical development and manufacturing. Our outstanding track record is rooted in innovation, quality and regulatory excellence, along with a genuine commitment to customers who rely on us to deliver the goods on time, every time.
With flexible global manufacturing in mammalian cell culture, supported by impeccable track record andseveral unique technologies,we are addressing unmet needs in a more sustainable and cost efficient way.
Preclinical & CT1/2
For our clients, fast and efficient progress into Phase I and Phase II clinical studies is crucial. Key to this effort is the establishment of a solid foundation. In these early stages of development our team applies its vast experience to provide development and manufacturing services to meet the needs of the project. We ensure the timely development of robust and scalable processes for transfer to GMP manufacturing. In addition, Genwell Biologics also performs cGMP cell banking services where Master and Working Cell Banks are tested and characterized to the appropriate ICH Guidelines.
For over 25 years we have worked with a vast array of biopharmaceutical targets, including recombinant proteins and monoclonal antibodies. With this breadth of knowledge comes experience in working with a wide range of mammalian cell lines, including CHO, myeloma and PER.C6®, as well as a wide range of cell culture processes, such as fed-batch, perfusion and XD®. Furthermore, this cell culture experience is complemented by a wide range of downstream processing capabilities, including column and membrane chromatography, TFF, UF/DF. These early development activities are underpinned by a sound analytical capability to support both process development and GMP manufacture.
A key focus in such early development is to gain process understanding knowledge to aid the design of processes suitable for process validation studies at a later date.
Process robustness and consistency, together with Quality and manufacturing excellence, underpins our proven ability to deliver on time, every time.
CT3
The execution of the pivotal clinical studies is key for our clients during Phase III, including the definition of the dosage to be used. The earlier development of a robust process ensures a consistency in manufacturing enabling a seamless supply of product in support of these pivotal clinical studies. Furthermore, our work also focuses on the establishment of a process validation work in support the commercial regulatory filing. In collaboration with the client, we use our experience to design and execute a process validation work package in support of the overall regulatory strategy.
Commercial
We provide flexible commercial manufacturing under full cGMP conditions while, in discussion with the client, our dedicated team continues to search for new ways of optimizing the existing process as appropriate.
In addition to manufacturing of the drug substance, we also provide Finished Product services through our sister unit based in the USA. Greenville, NC provides a wide range of sterile and solid dosage forms as well as pharmaeutical development services including packaging. Most importantly of all, with DSM you are guaranteed security of supply and online delivery – a critical factor for all our pharma customers.
Biosemilars
Increasingly we’re seeing that the market for biosimilars is growing fast with major opportunities for those with the scientific, technical and regulatory knowledge required.
A competitive landscape in the biosimilar field, dictates that Cost of Goods and pricing are key features of success where a quick return on development investment is essential. For these reasons it is crucial to put your product in the hands of a trusted, reliable partner. Look no further…
Process concepts
DSM’s provides unique, state-of-the-art and breakthrough technologies which , maximize yields, ensure the highest quality, and help you maintain a competitive cost advantage.
The seamless integration of a number of process permutations is possible to help you achieve your objectives, and may include any individual process or combination of the following:
- Fed-batch and perfusion processes
- XD® Technology: A breakthrough upstream process for maximizing yields up to 15 times of the typical industry process, while ensuring cost efficiency and reducing timelines
- RHOBUST® Technology: A downstream process that significantly reduces timelines while maintaining the highest quality
- The Kremer Method™: A downstream process that combines impurity removal steps and minimizes buffer and resin usage
As a partner of choice with respect to biosimilar development, our technologies impart a game changing impact on Cost of Goods. Companies turn to DSM for its strong track record of success across all of these processes and technologies and for the flexible approach to meeting your budget, timelines and distinct challenges.