The Real Revolution in Bioteh is just Starting the new Frontier of Biosimilars

Aequilibrium pharma is a privately owned, fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high quality biosimilar products. We are specialists in biogeneric product creation, all along the value chain from cell line development to commercial manufacturing.

Aequilibrium Pharmaceutical company are continuously searching for the safest, fastest and most cost effective methods to bring quality drugs to market. Biosimilars, Biotech, Pharmaceuticals, generics products are developed under tight deadlines, competitive pressures and regulatory compliance.

Aequilibrium Pharmaceuticals work to ensure consistent revenue streams, speed production and delivery of products, minimize disruption and adhere to FDA& EMA guidance, compliance & regulatory requirements such as Current Good Manufacturing Processes (CGMP), (GxP) and 21CFR11.

Aequilibrium Pharmaceuticals multimedia management systems solutions require delivery of a unified, configurable, multimedia control platform for marketing, R&D, clinical systems, health data, as well as trial outcomes and health research to enable researchers to gain insights into the viability, safety, and efficacy of new and existing therapies. Equilibrium can help drive greater discovery productivity and regulatory compliance through its extensive product line.

Strong and Robust Biosimilars and Biotech Our Specialty PIPELINE

Aequilibrium Pharma is a biotechnology company developing and commercialising high quality biosimilars.

The company is focused on creating a deep pipeline of clinically identical biosimilars at significantly reduced prices for entry into both new and established markets.

Our current pipeline consists of severals biosimilars and several monoclonal antibodies aimed at treating cancer, autoimmune, inflammatory and other diseases.

We develop, produce and release our biosimilars in house with the latest available technology and to the highest quality standards for the supply of finished and ready to commercialize products worldwide.

Aequlibrium pharma sign and agreement with one of the world’s premier provider of services related to preclinical development of biosimilars. 

Our partner offers stable Cell line development for high-titer and scalable manufacturing of various molecules (e.g., IgG1, IgG2, IgG4 and non-antibody proteins).

We have optional access to different cell lines and optimized vector systems for transfection.

 

Originator

Biosimilar Protein to 

Cell lines available

 API/BULK Available

Yervoy®

Ipilimumab

 

Perjeta®

Pertuzumab

Entyvio®

Vedolizumab

 

Herceptin®

Trastuzumab

Humira®

Adalimumab

Erbitux®

Cetuximab

 

Avastin®

Bevacizumab

Rituxan/MabThera®

Rituximab

 

Enbrel®

Etanercept

Synagis®

Palivizumab

 

Xolair®

Omalizumab

 

Myozyme®

Alglucosidase alfa

 

Zaltrap®

Aflibercept

 

Kineret®

Anakinra

Cimzia®  

Certolizumab

Solaris®

Eculizumab

 

Aldurazyme®

Laronidase

 

Tysabri®

Nalizumab

 

Keytruda®

Pembrolizumab

Praluent®

Alirocumab

 

Dupixent®

Dupilumab

 

Cerezyme®

Imiglucerase

 

Nucala®

Mepolizumab

 

Opdivo®

Nivolumab

Remicade®

Infliximab

 

We sign also and agreement with aprivately-held biopharmaceutical company focused on the rapid development and production of specialty antibody and protein drugs using their poprietary manufacturing platform based on plant based system. The plant-based system makes it easier, faster and less expensive to produce approved biologic drugs for novel indications and new markets.

The company’s technology uses genetically modified plants to produce biopharmaceuticals in fully contained greenhouse environments. Their plant-based technology delivers high drug expression levels and mammalian-type glycosylation (to eliminate the risk of an unwanted immune system reaction) also provides key advantages compared to other fermentation systems for biologic drug production (e.g., mammalian cell culture).

Biosimilars Technology Production

Aequilibrium Pharma has world leading expertise in the upstream development of biosimilars including mammalian cell line development and the analytics required to confirm biosimilarity.

With this collaboration , Aequilibrium Pharma has developed the platform as a part of its approach to biosimilars development.

with an an integrated platform for commercial scale manufacture of complex biologics, including monoclonal antibody and other protein drugs. The platform comprises a complementary portfolio of technologies designed to provide enhanced production of protein drugs, with major manufacturing advantages.

The system includes: 

 1)a robust and enhanced CHO and Plant cell line with superior viability and growth characteristics;

2) optimised expression vectors, designed for enhanced expression;

3) a low cost, chemically defined and animal component-free medium formulation designed to complement cell lines.

Biological Production Process

BIOSIMILAR DEVELOPMENT

 Determination of amino acid sequence and target profile of RMP

Cloning of synthetic target sequence into high-titter expression vector (gene of interest)

Transfection of Host cell line + single clone Preparation + Stability Assessment of Lead clone clone

Upstream and Downstream Process Development ( USP & DSP)

CELL BANKING (RCB)

Technology Transfer to production site (CDMO)

cGMP to production site (CMO)

Technology Transfer trading & Parellel Import

We trade in API, Bulk and FDF( finish dosage forms).

 

Available Technologies

Recombinant Human Erythropoietin (EPO) and Pegylation of EPO

Recombinant Human Interferon α2a (IFNα2a) and Pegylation of IFNα2a

Recombinant Human Granulocyte Colony Stimulating Factor (GCSF) and Pegylation of GCSF

Recombinant Human Insulin

Insulin Degludec

Insulin Detemir

Recombinant Human Interferon β1b

Pegylation of Recombinant Human Interferon β1a

Recombinant Human Growth Hormone

Recombinant Hepatitis B Surface Antigen (R-HBsAg) 

 

Technology transfer beneficiaries are the sole responsible entity for the research, development and for the commercial use of the transferred technologies.

Agreements with Aequilibrium Pharma do not include consultation and/or provision of certificates of analyses for biopharmaceutical regulatory purposes.