	NeuClone's advantage in biosimilar drug production Many global generic pharmaceutical companies are developing biosimilars. Prominent obstacles to entry into this market include the sizeable investments in time and expertise associated with cell line development. NeuClone has a number of distinct advantages to offer drug manufacturers who are investing in biotech drug development programs, including: Reduced risk of investment Clients rely on NeuClone’s knowledge, skill and expertise to provide high quality cell lines for use in manufacturing their biological drugs of choice. Reduced regulatory risk NeuClone’s cell lines are specifically generated for the commercial production of biosimilar APIs according to European Medicines Agency (EMA) Guidelines on Similar Biological Medicinal Products. NeuClone’s development program consists of early-stage analytical and bioanalytical assays to show that the biosimilars produced using NeuClone’s technology are highly similar to the reference biological product. NeuClone will assess all the relevant characteristics of the protein product to maximise the potential for detecting differences between the proposed biosimilar and the reference product. Reduced time to market Cell line development is time consuming and often takes several months to obtain a stable, high producing cell line suitable for cost effective manufacturing. NeuClone is generating a broad range of cell lines engineered to produce biosimilars closely resembling the originator drugs. By licensing NeuClone’s cell lines, clients can begin manufacturing immediately and reduce the time to market. Reduced cost By using NeuClone’s cell lines, our clients avoid making erroneous experimental decisions and costly mistakes in developing manufacturing processes. Each of NeuClone’s cell lines is subject to a rigorous process development regime including media optimization and a feeding strategy to boost titres whilst maintaining biological potency and integrity.

NeuClone's advantage in biosimilar drug production

Many global generic pharmaceutical companies are developing biosimilars. Prominent obstacles to entry into this market include the sizeable investments in time and expertise associated with cell line development. NeuClone has a number of distinct advantages to offer drug manufacturers who are investing in biotech drug development programs, including:

Reduced risk of investment
Clients rely on NeuClone’s knowledge, skill and expertise to provide high quality cell lines for use in manufacturing their biological drugs of choice.
Reduced regulatory risk
NeuClone’s cell lines are specifically generated for the commercial production of biosimilar APIs according to European Medicines Agency (EMA) Guidelines on Similar Biological Medicinal Products. NeuClone’s development program consists of early-stage analytical and bioanalytical assays to show that the biosimilars produced using NeuClone’s technology are highly similar to the reference biological product. NeuClone will assess all the relevant characteristics of the protein product to maximise the potential for detecting differences between the proposed biosimilar and the reference product.
Reduced time to market
Cell line development is time consuming and often takes several months to obtain a stable, high producing cell line suitable for cost effective manufacturing. NeuClone is generating a broad range of cell lines engineered to produce biosimilars closely resembling the originator drugs. By licensing NeuClone’s cell lines, clients can begin manufacturing immediately and reduce the time to market.
Reduced cost
By using NeuClone’s cell lines, our clients avoid making erroneous experimental decisions and costly mistakes in developing manufacturing processes. Each of NeuClone’s cell lines is subject to a rigorous process development regime including media optimization and a feeding strategy to boost titres whilst maintaining biological potency and integrity.

Biosimilar drug portfolio

NeuClone is applying its suite of technologies to generate a portfolio of cell lines expressing biosimilars. NeuClone has a number of NeuCHO™ cell lines producing biosimilar monoclonal antibodies (mAbs) available for licensing. In addition to biosimilar mAbs, NeuClone is developing cell lines expressing other complex biosimilar APIs requiring post translational modification.

Our business is to make an almost exact copy of off-patent biologic APIs - from primary sequence to finished product according the guidelines established by the European Medicines Agency’s on Similar Biological Medicinal Products.