KNOWLEDGE BANK

Interviews

Knowledge Gain Through High Parallel Bioprocess Setups

Product Life Cycle Manager, Eppendorf AG
Sebastian Kleebank studied Bioengineering at the University of Applied Sciences in Juelich followed by his PhD at the RWTH Aachen Institute for Molecular Biotechnology In his actual position as a Product Life Cycle Manager at Eppendorf AG Business Unit Bioprocess he is responsible for the smallscale product portfolio During his years in the bioprocess industry he gained a lot of experience in sma...

Articles

Integrated by Design

Combination products which integrate a drug andor biologic component with a medical device component are increasing globally Because they do not fit neatly into a single category regulation of these products can be difficult to navigate

Research Insights

A Multiple Instance Learning Approach for Detecting COVID-19 in Peripheral

A wide variety of diseases are commonly diagnosed via the visual examination of cell morphology within a peripheral blood smear

Case Studies

Labile Biologics - Stable Aqueous Formulation of Recombinant Factor VIII

Challenge All marketed Factor VIII products are lyophilised preparations produced by either recombinant technology or purified from pooled plasma The preparations are typically stabilised by addition of sugars Administration of the lyophilised product is a very complex procedure involving a number

Techno Trends

Crysvita - A Breakthrough Therapy Developed For Treatment of TumorInduced Osteomalacia TIO

Crysvita burosumabtwza injection the first therapy discovered for the treatment of patients with rare disease tumorinduced osteomalacia TIO corresponding to the age two and older

White Papers

Cloud Computing in the Laboratory Informatics Solutions and Validation Approaches

In the modern business environment, a significant portion of work is conducted using computerized systems. Many solutions are used to complete tasks, including simple desktop programs like email and Microsoft Office to enterprise-wide, global systems like ERP (Enterprise Resource Planning), MES (Manufacturing Execution System), and LIMS

TOP ARTICLES

1

Six Sigma - Time, cost and product quality improvement

Ashwin Kuchekar

Ashwin Kuchekar is an Associate Professor and the Head of Career Services and Placement at the School of Pharmacy, Dr. Vishwanath Karad MIT-WPU in Pune. He completed his M. Pharm.in 2009 and Ph. D. in 2015. In 2012, he received the Senior Research Fellow (SRF) Award from the Council of Scientific Industrial and Research (CSIR).  He is a trained specialist in Lean Six Sigma Black Belt (LSSBB).  He has 7 years of industrial experience in reputed pharmaceutical companies such as Piramal, Lupin, and Abbott Healthcare. He has a unique blend of statistics and formulation development, Quality by Design with exposure to branded and generic product development. He has practical experience in the Design of Experiments and product formulation and process optimisation.

 

2

Automation in Pharmaceutical Sector by Implementation of Artificial Intelligence

Amol Shinde

Amol Shinde is Assistant Manager in Department of Medical Affairs and Pharmacovigilance at Unichem Laboratories Ltd., India with approx. 7 years of working experience in various corporate of pharma industries. He has published 4 papers in international and national journals.

 

3

When Orphan Drugs Make All the Difference

Sue Lee

Sue Lee has worked for World Courier for 25 years. During this time she has experienced a variety of customer service and operational functions, including the setting up of numerous, multi-national, clinical sites for the transportation of biological samples. She orchestrated the shipping of thousands of shipments with very specific temperature requirements to a host of challenging locations, and each presenting their own obstacles and dilemmas.

4

Untapped Opportunities in Southeast Asia

Sue Lee

Sue Lee has worked for World Courier for 25 years. During this time she has experienced a variety of customer service and operational functions, including the setting up of numerous, multi-national, clinical sites for the transportation of biological samples. She orchestrated the shipping of thousands of shipments with very specific temperature requirements to a host of challenging locations, and each presenting their own obstacles and dilemmas.

5

Revolutionising Tuberculosis Treatment test

Ashok Aspatwar

Ashok Aspatwar, MS, PhD, is an Adjunct Professor at Tampere University, Finland. His research focuses on carbonic anhydrases in Mycobacterium tuberculosis persistence and anti-TB drug development, using molecular biology, medicinal chemistry, and AI-driven bioinformatics to explore novel therapeutic pathways and target mechanisms in TB.

Rarchita Sharma

Rarchita Sharma, M. Pharm, is a researcher at SVKM's Institute of Pharmacy, specialising in novel drug delivery for CNS disorders. She has published seven papers on topics like regulatory filings, AI in stroke care, and cardiovascular drugs, aiming to advance therapeutic innovations in pharmaceutical sciences.

press releasesRead more...

Merck Opens €300 Million Asia-Pacific Bioprocessing Center in Daejeon, South Korea

Merck a leading science and technology company today opened its new AsiaPacific Bioprocessing Production Center in Daejeon South Korea The center represents an investment of more than million the companys largest Life Science investment in AsiaPacific to date

Flagship Pioneering Forms Etcelera to Move Drug Discovery from Probability to Prediction

Flagship Pioneering a scientific innovation engine for transformative platforms and products today announced the formation of Etcelera a company created by the merger of the platforms of Cellarity Cellarity Platform Inc Etiome and Empress Therapeutics to pioneer causal intelligence in human biology...

Junshi Biosciences Announces Acceptance of the Supplemental New Drug Application of Toripalimab (Subsutaneous Injection) for the 1st-Line Treatment of HER2-Expressing Urothelial Carcinoma

Shanghai Junshi Biosciences Co Ltd a leading innovationdriven biopharmaceutical company dedicated to the discovery development and commercialization of novel therapies announced that the supplemental new drug application for the companys product toripalimab injection subcutaneous injection

HUTCHMED Announces Sovleplenib Granted US FDA Orphan Drug Designation for Primary Immune Thrombocytopenia

HUTCHMED China Limited today announces that the US Food and Drug Administration FDA has granted Orphan Drug Designation to sovleplenib for the treatment of primary immune thrombocytopenia ITP an autoimmune disorder that can lead to increased

Transpharmation Ltd. Announces Strategic Acquisition of OrganoTherapeutics SARL

Were delighted to announce the strategic acquisition of OrganoTherapeutics SARL a leader in patientderived organoid technologies that advance the discovery and development of novel therapies for neurodegenerativeCNS disorders

EVERSANA Expands Global Commercialization and AI-Powered HEOR Capabilities with Acquisition of U.K.-based Estima Scientific

EVERSANA a global provider of modern AIpowered commercial services for the biopharmaceutical industry today announced the acquisition of Estima Scientific an innovative Londonbased health economics and outcomes research HEOR technology and services company

EventsRead more...

02 - 04

Nov 2026

Pharma Forum EMEA 2026

Dom Pedro Lisboa Hotel, Lisbon...

02 - 04

Nov 2026

Cancer R&D 2026

Houston, TX, USA

03 - 05

Nov 2026

10th Dermatology Drug Development

Boston, Massachusetts at The C...

03 - 04

Nov 2026

PDA Aseptic Processing of Biopharma Conference

Sheraton Grand Incheon Hotel,...

04 - 05

Nov 2026

Advanced Therapies USA

Hynes Convention Center, Bosto...

05 - 05

Nov 2026

PDA Contamination Control Strategy Workshop

Sheraton Grand Incheon Hotel,...

09 - 11

Nov 2026

11th Microbiome Movement USA Summit

The Colonnade Hotel, Boston, M...

10 - 11

Nov 2026

Extractables & Leachables Europe

Parkhotel Schӧnbrunn, Vienna,...

LATEST NEWSRead more...

Edison Scientific Enters into Agreement with Pfizer to Advance Drug Research and Development

Edison Scientific has entered into an agreement with Pfizer to introduce its Edison AI Platform and AI scientist Kosmos across Pfizers biopharmaceutical research and development activities The collaboration will combine Edison Scientifics artificial intelligence AI technology with Pfizers scientific...

Appian and PSI CRO Partner to Advance AI-driven Clinical Trial Operations

Appian and PSI CRO have entered into a strategic partnership to introduce an artificial intelligence AIpowered solution for clinical trial site identification and selection The solution is now live and is designed to automate site selection across different therapeutic areas medical conditions and...

Adalvo Acquires Romiplostim Biosimilar from Enzene

Adalvo has acquired a romiplostim biosimilar programme from Enzene expanding its portfolio of biosimilars and strengthening its presence in complex biological medicines The programme references Nplate romiplostim a medicine used to treat immune thrombocytopenia ITP in adults and children with chroni...

Twist Bioscience Launches Express Screening Antibodies for Faster Characterisation

Twist Bioscience has expanded its antibody production and characterisation portfolio with the launch of Twist Express Screening Antibodies a service designed to help researchers evaluate large numbers of antibody candidates more quickly The service uses a highthroughput cellfree production process t...

Astellas Enters into Agreement with Audax for Immuno-Oncology Candidate DAX-044

Astellas Pharma and Audax Biosciences have entered into an exclusive option and licence agreement for DAX an investigational antibodycytokine fusion being developed for cancer immunotherapy DAX is designed to deliver interleukin IL an immuneactivating protein more selectively to the tumour microenvi...

Sumitomo Pharma’s Enzomenib Receives Breakthrough Therapy Designation for Relapsed or Refractory KMT2A-Rearranged Acute Leukaemia

Sumitomo Pharma America has announced that the US Food and Drug Administration FDA has granted Breakthrough Therapy designation to enzomenib DSP for treating patients with relapsed or refractory acute leukaemia carrying a KMTA gene rearrangement