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oncomed > services

services

portfolio scope

We offer production of high potent and anticancer injectables in clinical and commercial scale including small molecule APIs drug products (end-to-end solution) and more innovative large molecule drug products (Fill & Finish service), like ADCs, HPAPI proteins & mAb and oligonucleotides.
As a specialized CDMO we bring our expertise to sterile processing and aseptic Fill & Finish of complex formulations.

formulations

  • liquid
  • liquid terminally sterilized
  • freeze dried

dosage forms

injectables – vials
(2 ml – 200 ml)

syringes & cartridges – in progress

manufacturing scale

small scale production
(pre-clinical, clinical phase I & II)

large scale production
(clinical phase III, commercial)

molecule type

small molecules
(HPAPI non-cyto, cytotoxic, cytostatic)

large molecules
(biologic, oligonucleotides)

difficult formulations

small molecules
end-to-end solution

  • development services
  • clinical supply services
  • manufacturing on commercial lines
  • commercial supply services
  • scalability of production including campaigning & line transfer possibility
  • analytical & microbiological services
  • analytical method development & validation
  • material and final product release

we offer end-to-end solutions covering the whole lifecycle of products with focus on “speed to market”. we are flexible and able to adapt processes and project set-up to fulfill customer needs.

Aleš Šima

head of business development
development services
clinical supply services
manufacturing on commercial lines
commercial supply services
scalability of production including campaigning & line transfer possibility
analytical & microbiological services
analytical method development & validation
material and final product release

are you looking for expertise in fill & finish of high-potent biomolecules? we are here to help you.

large molecules fill & finish

We transform our long history and expertise in sterile processing and aseptic Fill & Finish into large molecules space by using a state-of-the-art isolator line combined with a single-use system technology.

single use systems

  • filtration
  • bulk handling
  • filling
  • no cross-contamination

gentle handling

  • a paddle mixer
  • peristaltic pumps
  • careful freezing/thawing

freeze drying

  • organic solvents
  • a dual cooling system (liquid nitrogen)
  • automatic loading/unloading

low hold-up volumes

  • less than 800 ml

biomolecules

  • antibodies
  • ADCs
  • peptides, proteins
  • oligonucleotides

difficult formulations

  • temperature control
    (-70°C to +30°C)
  • oxygen sensitive
  • light protection
  • dispersion systems
  • organic solvents

isolator filling

  • low residual peroxide (< 0.1 ppm)
  • VHP decontamination
  • a weighing isolator
  • a filling isolator

actives

  • cytotoxic, cytostatic
  • non-cytotoxic
  • high potent (OEB 4, OEB 5)
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single use systems

core services

development

Literature search scoping, pre-formulation, formulation studies and lyophilization cycle development are assured by our qualified external partners. Our in-house capabilities further support process development, optimization and scale-up. Stability studies, analytical and microbiological method development & validation are assured in-house and/or in cooperation with qualified external partners.

clinical supply

Clinical batches are manufactured on commercial lines which assure cost savings related to eventual tech-transfer and commercial supplies of the products. We offer various vial formats in wide range of batch sizes in order to cover all clinical phases.  By using a single-use system technology, we offer clinical Fill & Finish services also for biomolecules and high-price APIs.

commercial supply

We offer various vial formats in wide range of batch sizes in order to fulfil the commercial needs of our partners and to adapt to unexpected market changes. The commercial supplies are assured via agile and seamless technology transfer covered by our Project Management Office  with all necessary support services included. By using a single-use system technology, we offer commercial Fill & Finish services also for biomolecules and high-price APIs.

supplementary services

analytical/microbiological

Service is offered to support development and clinical & commercial supply activities of small molecules. Our team of experts provides support in analytical/microbiological method transfer/validation covered by Project Managers, product release testing, cleaning methods development and validation, raw materials testing in compliance with cGMP, environmental monitoring, bioburden, bacterial endotoxins and sterility. Our state-of-the-art analytical equipment covers all necessary methods and we have extensive network of qualified laboratories to cover all needed methods which are not available in-house.

stability

We offer complete stability service which includes ICH, photostability, Zone IV, infusion, in-use, transportation studies and storage of  samples.

optical inspection

We offer semi-automated inspection using Seidenader device and manual inspection assured by highly qualified operators.

packaging & storage

In-house capabilities include manual transport packaging (labelling, box, carton). Automated packaging including serialization and track & trace is assured via a qualified external partner. Storage covers all basic conditions in qualified warehouses including cold chain storage conditions.

regulatory & batch release

We offer technical bulk release for further processing by our team of qualified persons. Batch certification to market is assured via a qualified external partner.

why choose oncomed?

#reason 1

employee skills & mindset

Employees are the driving force of our company. Together we are able to achieve even the most courageous goals. We believe that thanks to our knowledge, flexible approach and endeavour to look for the solution, we can fully support clients in their needs.

#reason 2

variety of niche technologies in house

We believe that thanks to our state-of-the-art technologies, such as organic solvents handling or single-use systems, clients can dare to act with courage too and ask for advanced highly active drug solutions. We (and our technology) will support them during all stages of the project.

 

learn more

#reason 3

supply risk mitigation

We understand the cost and time pressures faced by pharmaceutical companies, therefore we offer flexible, affordable and rapid outsourcing services designed to meet specific development and manufacturing needs of our clients. In addition, because drug development processes are often challenged with unexpected clinical and marketing changes, we have the operational capability to quickly respond to all project variations.

#reason 4

manufacturing capacity

We offer fully operational line 1 and line 2. However, we keep investing into our manufacturing capacity and state-of-the-art technologies – construction of line 3 focused on syringes and cartridges is projected within five years. 

#reason 5

no additional major investments

We offer 2 ml – 200 ml vial formats, variable equipment sizes and qualified processes. We maintain our service offerings transparent.

supply risk mitigation factors

scalability
financial stability
advanced and efficient methodology in project management
excellent audit history

where courage meets knowledge

quality policy

we live quality

The highest quality of products and processes creates the heart of our everyday business. Quality is built into our everyday processes and living quality has become natural to all our employees. 

certification

Our quality system is in line with all EU GMP, ICH, WHO, PIC/S regulations and soon to be FDA inspected. The quality system is being continuously improved in order to meet the latest development of the regulatory environment.