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Services

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Our exclusive contract manufacturing services are offered starting from Pre-clinical, through all clinical stages to commercial supply.

There are four key areas of expertise:

   1. High Potency Active Ingredients (HPAIs)

   2. Antibody Drug Conjugates (ADCs)

   3. Recombinant Proteins and monoclonal Antibodies

   4. Pharmaceutical Probiotics

From proof of concept through to commercialization, Cerbios is focused on scientific and regulatory strategies for chemistry, manufacturing, and control (CMC).

Cerbios provides regulatory guidance in setting specifications, methods development, validations and stability studies.

Besides that, Cerbios offers CMC regulatory services with preparation and review of regulatory submission and direct interaction with the Authorities world-wide

Chemical division
Chemical Services
High Potency Active Ingredients Services
Chemical Services

With over 30 years' expertise in industrial scale manufacturing of APIs and over 19 years' experience in handling HPAIs (High Potency Active Ingredients) according to cGMP, Cerbios is highly qualified in the process development of new HPAIs up to industrial and commercial production.
During the last few years, Cerbios has made substantial investments in infrastructure to strengthen and extend its activities and services in the field of HPAIs.
All containment facilities are designed and based on a modern zone concept with pressure cascades, airlocks and access controls.

The plants have been tested by SafeBridge® and confirmed to exceed category 4 SafeBridge® (OEL<30 ng/m3) reaching OEL<10 ng/m3.

Biological division
Biological Services
From Pharma Probiotics to antibodies
Biological Services

Starting as Bioferment SA in 1976 with research into probiotic pharmaceuticals and feed additives and their development and production, the Biological Division of Cerbios further developed its expertise in the late 90’s by working on CHO mammalian cell systems and technologies for cloning, production and purification of recombinant proteins and monoclonal antibodies for therapeutic use.

Cerbios' Biological Division offers contract manufacturing services on an exclusive basis for partners world-wide in the following areas:

  1. Monoclonal antibodies (mAbs) and recombinant proteins based on CHO mammalian cells
  2. Development and manufacturing of pharmaceutical probiotics
Chemical division
Integrated development of Topical Drugs
Cerbios offers a fully integrated service for the development of New Chemical Entities for dermatological use.The Drug Substance: developed and manufactured in our FDA inspected facilities in...
Discover more
Chemical division
Antibody Drug Conjugation (ADCs) Development an...
With more than  30 years' expertise in industrial scale manufacturing of APIs and over 20 years' experience in handling HPAIs according to cGMP, Cerbios is highly qualified in process development...
Discover more
Chemical division
HPAIs Chemical Contract Manufacturing
With over 30 years' expertise in industrial scale manufacturing of APIs and over 20 years' experience in handling HPAIs according to cGMP, Cerbios is highly qualified in process development and...
Discover more
Chemical division
1. Technology Transfer, Process Development and...
Cerbios can conduct de novo process development from the Process Scale up to Preclinical Study Materials along with transfer in processes that need to be optimized or scaled up to fulfill...
Discover more
Chemical division
2. Analytical Development
Cerbios provides a full range of analytical services, including methods development and validation, analytical testing and release, stability studies and regulatory CMC documentation services.In...
Discover more
Chemical division
3.Process and Analytical Validation
Analytic method development, validation, and transfer are key elements of any pharmaceutical development program.Cerbios’ long-term experience in product development and manufacturing is reflected...
Discover more
Chemical division
4. Regulatory Support
Cerbios has more than 30 years of experience and knowledge in successfully submitting DMFs for APIs, HPAIs and Biologics to the major authorities worldwide.Type II DMFs to the US FDA , DMF or CEP...
Discover more
Chemical division
5. Commercial Production and process improvments
Continuous improvements, within the regulatory frame, are essential in order to make the process more efficient providing improvements at:1. Impurity profile2. Yields and cost3. Improved...
Discover more
Biological division
Pharmaceutical probiotics: contract manufacturi...
Cerbios is considered to be a leading company worldwide in the field of probiotics for pharmaceutical use.Cerbios can offer its customers probiotics of pharmaceutical quality as well as contract...
Discover more
Biological division
Biotechnology Services
Cerbios offers a high quality and tailor-made development program for biopharmaceuticals.Working with recombinant DNA technology to manufacture monoclonal antibodies , antibody fragments or...
Discover more
Biological division
1. Cell Line Development for rec Proteins and mAbs
Cerbios offers customized high-performance stable mammalian cell line development for manufacturing of monoclonal antibodies and recombinant proteins.Cerbios is setting up a platform for the...
Discover more
Biological division
2. Research Cell Bank Evaluation and Cell Banks...
Cerbios evaluates the RCB thoroughly to obtain a target biological analytical proof -of -concept sample. In addition, Cerbios provides MCB and WCB under GMP conditions and related regulatory...
Discover more
Biological division
3. Process development activities: upstream,dow...
Our goal is to enable our clients to reduce the time required to develop a product and produce cGMP biomolecules for clinical trials, developing robust and scalable manufacturing processes  Our...
Discover more
Biological division
4. Scale-up to engineering batch: guarantee of ...
An engineering batch is made prior to full scale cGMP batch, to fine-tune the process, finalizing batch production records and finalizing a process control strategy.Cerbios considers the...
Discover more
Biological division
5. GMP Manufacturing Capabilities for Biopharma...
Cerbios' state of the art cGMP production facilities comply with international regulatory requirements and guarantee a Swiss quality assurance system with extensive technical and regulatory...
Discover more
Chemical division
Biological division
Chemical Services
Chemical Services
High Potency Active Ingredients Services

With over 30 years' expertise in industrial scale manufacturing of APIs and over 19 years' experience in handling HPAIs (High Potency Active Ingredients) according to cGMP, Cerbios is highly qualified in the process development of new HPAIs up to industrial and commercial production.
During the last few years, Cerbios has made substantial investments in infrastructure to strengthen and extend its activities and services in the field of HPAIs.
All containment facilities are designed and based on a modern zone concept with pressure cascades, airlocks and access controls.

The plants have been tested by SafeBridge® and confirmed to exceed category 4 SafeBridge® (OEL<30 ng/m3) reaching OEL<10 ng/m3.

Biological Services
Biological Services
From Pharma Probiotics to antibodies

Starting as Bioferment SA in 1976 with research into probiotic pharmaceuticals and feed additives and their development and production, the Biological Division of Cerbios further developed its expertise in the late 90’s by working on CHO mammalian cell systems and technologies for cloning, production and purification of recombinant proteins and monoclonal antibodies for therapeutic use.

Cerbios' Biological Division offers contract manufacturing services on an exclusive basis for partners world-wide in the following areas:

  1. Monoclonal antibodies (mAbs) and recombinant proteins based on CHO mammalian cells
  2. Development and manufacturing of pharmaceutical probiotics
Chemical division
Integrated development of Topical Drugs
Cerbios offers a fully integrated service for the development of New Chemical Entities for dermatological use.The Drug Substance: developed and manufactured in our FDA inspected facilities in...
Discover more
Chemical division
Antibody Drug Conjugation (ADCs) Development an...
With more than  30 years' expertise in industrial scale manufacturing of APIs and over 20 years' experience in handling HPAIs according to cGMP, Cerbios is highly qualified in process development...
Discover more
Chemical division
HPAIs Chemical Contract Manufacturing
With over 30 years' expertise in industrial scale manufacturing of APIs and over 20 years' experience in handling HPAIs according to cGMP, Cerbios is highly qualified in process development and...
Discover more
Chemical division
1. Technology Transfer, Process Development and...
Cerbios can conduct de novo process development from the Process Scale up to Preclinical Study Materials along with transfer in processes that need to be optimized or scaled up to fulfill...
Discover more
Chemical division
2. Analytical Development
Cerbios provides a full range of analytical services, including methods development and validation, analytical testing and release, stability studies and regulatory CMC documentation services.In...
Discover more
Chemical division
3.Process and Analytical Validation
Analytic method development, validation, and transfer are key elements of any pharmaceutical development program.Cerbios’ long-term experience in product development and manufacturing is reflected...
Discover more
Chemical division
4. Regulatory Support
Cerbios has more than 30 years of experience and knowledge in successfully submitting DMFs for APIs, HPAIs and Biologics to the major authorities worldwide.Type II DMFs to the US FDA , DMF or CEP...
Discover more
Chemical division
5. Commercial Production and process improvments
Continuous improvements, within the regulatory frame, are essential in order to make the process more efficient providing improvements at:1. Impurity profile2. Yields and cost3. Improved...
Discover more
Biological division
Pharmaceutical probiotics: contract manufacturi...
Cerbios is considered to be a leading company worldwide in the field of probiotics for pharmaceutical use.Cerbios can offer its customers probiotics of pharmaceutical quality as well as contract...
Discover more
Biological division
Biotechnology Services
Cerbios offers a high quality and tailor-made development program for biopharmaceuticals.Working with recombinant DNA technology to manufacture monoclonal antibodies , antibody fragments or...
Discover more
Biological division
1. Cell Line Development for rec Proteins and mAbs
Cerbios offers customized high-performance stable mammalian cell line development for manufacturing of monoclonal antibodies and recombinant proteins.Cerbios is setting up a platform for the...
Discover more
Biological division
2. Research Cell Bank Evaluation and Cell Banks...
Cerbios evaluates the RCB thoroughly to obtain a target biological analytical proof -of -concept sample. In addition, Cerbios provides MCB and WCB under GMP conditions and related regulatory...
Discover more
Biological division
3. Process development activities: upstream,dow...
Our goal is to enable our clients to reduce the time required to develop a product and produce cGMP biomolecules for clinical trials, developing robust and scalable manufacturing processes  Our...
Discover more
Biological division
4. Scale-up to engineering batch: guarantee of ...
An engineering batch is made prior to full scale cGMP batch, to fine-tune the process, finalizing batch production records and finalizing a process control strategy.Cerbios considers the...
Discover more
Biological division
5. GMP Manufacturing Capabilities for Biopharma...
Cerbios' state of the art cGMP production facilities comply with international regulatory requirements and guarantee a Swiss quality assurance system with extensive technical and regulatory...
Discover more
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