Biologic Drugs

What is a modular system and how are modular systems being used in the biopharmaceutical industry? Pär

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

Gallus BioPharmaceuticals enters a cell line optimization and manufacturing agreement with Omni Bio Pharmaceutical.

TAP Biosystems announced that Gallus BioPharmaceuticals is using its ambr15 micro bioreactor system to optimize process development and clone selection of novel antibody therapeutics and biosimilars.

Higher antibody titers and a growing demand for smaller-volume, flexible processes are creating the need for more cost-effective downstream processing.

With nanomedicines on the rise, a new class of non-biological complex drugs (NBCDs), which include nanosimilars, has emerged. As drug regulators are faced with the challenge of defining a framework to ensure the safe introduction of the follow-on nano-therapeutics, Stefan Muhlebach explains why NBCDs cannot be assessed using the standard generic or biosimilar approaches.

CMOs may find opportunities in alternative expression services.

Automated sample handling, advanced glycan analysis, and specially designed columns are help speed up confirmation of the biosimilarity.

A changing biopharmaceutical industry is going beyond typically outsourced activities and is using CMOs for more challenging processes. Review the top 10 outsourcing trends.

PharmaCell enters an agreement purchase TiGenix therapy production facility.

With numerous biologics set to come off patent soon and the percentage of new therapeutics based on biomolecules growing, demand for contract manufacturing in the biopharma space is heating up.

NMR analysis provides crucial structural information of synthesized glycans while LC-MS/MS is ideal for quantitation of free sugars in biological matrices.

Antibody fragments pose unique challenges in terms of recovery, purification, and formulation.

With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.

CMC Biologics and OnoSynergy form an agreement from cell-line development.

BioWa and Lonza have entered into a licensing agreement with MedImmune for cell line technology.

Jill E. Sackman, D.V.M., PhD, senior consultant at Numerof & Associates, Inc. discusses the market forces impacting biopharmaceutical manufacturing

The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA).

Covance Inc. and Pathoquest have announced a collaboration to provide next-generation sequencing (NGS) based biosafety assessments to detect and identify viral contaminants within biologic compounds.

Industry experts discuss the importance of characterization studies during biosimilars development and related analytical methods.

Pfizer advances its pipeline of antibody-based therapies using a host cell line that combines engineered glycosylation technology and enhanced gene-expression.

Novartis? half-billion dollar investment in a new biologics production plant in Singapore represents a strategic commitment to its growing biologics portfolio.

Following passage in the California Assembly, the California State Senate passes legislation to specify requirements for dispensing biosimilars.

Industry experts discuss the requirements and challenges involved in getting a biosimilar product from bench to launch.

Conventional cell-imaging systems that provide high quality data can be expensive and complex to use. New systems from Biotek Instruments are designed to overcome these issues.

Installation of a quaternary chiral center with high enantioselectivity using memory of chirality enabled the six-step synthesis of the desired active compound.

Extensive adoption of single-use technologies and unidirectional flow reduces cross-contamination risk in the company?s new biomanufacturing facility.

Conventional cell-imaging systems that provide high quality data can be very expensive and complex to use. New systems from Biotek Instruments are designed to overcome these issues.

Extensive comparability testing is required to ensure that biosimilars have comparable profiles to their reference products.

The US Supreme Court's Myriad decision satisfied both patient groups and patent holders