MPTxpress enables us to produce biologics on a rapid, reliable and repeatable scale-up

MPT Biotech
 
Frost & Sullivan 2012 Best Practices Award

Contract Manufacturing Organization (CMO) Services

The R&D pipeline for new drugs has changed considerably over the past decade. Once dominated by big pharma and small molecules, today’s pipeline is increasingly populated with small and emerging biotech companies developing large molecules, or biologics, which now make up nearly 40% of the active R&D pipeline globally. As scientific advancement in biopharmaceuticals continues to rise, so will the market. The global biological market size is expected to reach $750 billion in 2028 — up from the $285 billion biologics revenues seen in 2020. This rapid and continual growth has created a demand for therapeutics, expanding indications for biologics, and the growing portfolios of biologics. Biologics are mainly used for treatment of conditions such as cancer, infectious, ophthalmic, anemia and autoimmune diseases and the current success rate is encouraging bio-pharmaceutical players to invest in research and development of biologics on large scale. While these projections are good news for patients and for makers of bio therapies, growth always comes with new challenges. In this case, the industry must learn how to deploy efficient, flexible-modular manufacturing technologies that can respond to upstream and downstream variables. These variables include the proliferation of new biologics, rapid shifts in volumetric requirements, and improvements in cell and bacterial culture strategies.

MPTxpress process is well positioned to offer tangible benefits such as modular batch size, lower operating cost, and faster turnaround and reduced capital investment. We draw on our manufacturing and quality expertise to design processes that optimize

GMP Biologic Development and Manufacturing

MPTxpress Process Development Services and Capabilities
MPT routinely performs upstream and downstream development and optimization studies for our clients, is a critical step towards efficient design of GMP-compliant manufacturing processes.

Protein Purification and Bulk Fill
MPT has experience with a wide range of protein purification capabilities to meet client’s GMP production needs. Protein purification areas at MPT are segregated and customized with equipment to meet the requirements of client’s process. Protein purification personnel at MPT are experts with protein refolding, multiple chromatography techniques, tangential flow filtration, lyophilization, and bulk drug substance filling.

Microbial Cell Banking
MPT Biologics manufactures and cryo-stores Working and Master Cell Banks to support current and future upstream and downstream requirements. Microbial Cell Banks are cryo-stored in the vapor phase of liquid nitrogen freezers. MPT manages and coordinates all required testing per ICH and FDA guidelines.

MPT has experience with modular MPTxpress of E.coli. MPTxpress processes are demonstrated in process development and scaled-up for GMP in our facility.

Few samples of CRO and CMO projects performed at MP

G1: SDS-PAGE Analysis of Biologic Drug Substance SB1 (sdAbs/Nanobodies).
Lane 1, M.W marker; Lane 2, SB1 5ug reducing condition; Lane 3, SB1 5ug non-reducing condition.
GMP grade Biologic Drug Substance SB1 manufactured at MicroProtein Technologies.

G2: SDS-PAGE Analysis of Biologic Drug Substance KB1 (Enzyme drug).
Lane 1, MW markers; Lane 2, 0.5ug; Lane 3, 1ug; Lane 4, 2ug reducing condition.
GMP grade Biologic Drug Substance KB1 manufactured at MicroProtein Technologies.

G3: 2ug of GMP-grade recombinant human FGF basic resolved by SDS-PAGE reducing conditions, showing a single band at 17 kDa.

G4: 2ug of recombinant human IL-2 resolved by SDS-PAGE reducing condition, showing a single band at 15.5 kDa.

G5: 2ug of recombinant Protein G resolved by SDS-PAGE reducing condition, showing a single band of 22.5 kDa.

G6: 2ug of recombinant Protein A resolved by SDS-PAGE reducing condition, showing a single band of 35 kDa.

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