Endotoxin detection in laminin biomolecules at BioLamina AB

Expires in 9 days

 About the degree work

Biotechnological products follow strict regiments of low endotoxin levels, and often use the same guidelines and regulatory framework as biological medicines. There are several compendial methods traditionally used to determine the endotoxin levels in a finished product, intermediates and in process controls, and these assays need to be validated to ensure that the methods produce accurate and reproducible results. Many assays use or are derivates of the traditional method using amoebocyte lysate from the horseshoe crab (Limulus polyphemus or Tachypleaus tridentatus), while several new artificial assays exist or are being developed in the industry. The traditional LAL-method have known limitations where natural (1,3) -β-D-glucan, a natural polysaccharide found in some fungi, plants and bacteria, can interact and interfere with the assay producing false positive results.

 

Job assignment

You will perform comparison studies of at least three different commercial and compendial methods to determine endotoxin levels, to identify possible sources of interference and any relationship between these. These studies will be performed on our finished products  , intermediates and in process controls   during the production cycle of BioLaminins, with samples that have different grades of purity.

 

Degree project goals

  • Perform comparison studies between the recognized and compendial methods between LAL methods and rFC (recombinant factor C) for endotoxin detection
  • Investigate, analyze, and identify possible sources of interference and any relationship between endotoxin level and interference
  • Determine the most suitable method to determine endotoxin levels in BioLamina´s finished products, intermediates and in process controls

 

Who are you?

You are at the end of your Master of (Medical) Science within the Life Sciences, drug development or pharmaceutics in an accredited higher education in the European Union. Courses and knowledge that are important to have for this degree work to be successful is biochemistry, microbiology, general analytical laboratory techniques and experience working with eucaryotic  cells, a working knowledge of statistics and excellent English language skills, both spoken and written.

 

Other information

The degree work is for 30 ECTS credits (20 weeks) during the spring of 2023. Placement is in Sundbyberg, a close suburb to Stockholm (ca 6km from Stockholm city), with excellent commuting opportunities (bus, tram, subway and train).

 

For any questions about the degree work, please contact Dr. Fatemeh Madani at fatemeh.madani(at)biolamina.com, project supervisor, or Dr. Harald Eriksson harald.eriksson(at)biolamina.com, recruiting manager.              

About Biolamina:

 

BioLamina AB is a Swedish based Biotech company that originates from scientific innovations at Karolinska Institute. Our main products are recombinant laminins, human proteins that are being used to maintain and expand pluripotent stem cells and other primary cell types and for subsequent differentiation into different specialized cell types. BioLamina is revolutionizing cell culture and our products are being used by researchers to develop cell therapies, building on the era of regenerative medicine. Founded in 2009, BioLamina has grown organically and today we are a team of more than 60 people who develop, produce, market, and sell cell culture research reagents to academic and industrial clients globally.    The company has a certified quality system according to ISO 9001:2015.

For more information, please see: http://www.biolamina.com

European Medicines Agency, ICH Q4B Annex 14 Bacterial endotoxins tests

European Pharmacopoeia, 2.6.14 Bacterial endotoxins

Attention: Often you need a pre-approval from your university or study counselor, to ensure that projects or thesis found on Graduateland will be accepted as part of your education. Please contact the right entity in due time to ensure that you're picking the right project.