Biologic Drugs

EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.

Forecasts were lowered, Reuters reported, due to reduced drug approvals and increased competitive pressures.

Companies believe that biologics and biosimilars would experience the fastest growth over the next year; there is also interest on increasing market penetration of generic drugs.

Sandoz, a Novartis division, announced  that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending the approval of its biosimilars rituximab and  etanercept in Europe, for the same indications as the respective reference medicines.

The funding allows the company to broaden its range of services and finance its move to new laboratory facilities in the Illkirch-Graffenstaden innovation park in northeast France.

Researchers continue efforts to overcome challenges of effective oral delivery of biologic drugs.

New study shows China biopharma companies face staffing shortages.

The transfer of fluids is governed by different equipment requirements across the medical, biopharma, and cell therapy manufacturing industries.

The process control and automation requirements of single-use systems differ from those of stainless-steel equipment.

The facility in Britley will now manufacture the company’s automated systems, enabling the company to better serve European markets and shorten the supply chain.

In a FDAVoice blog post, CBER Director Peter Marks discusses the new designation for cell therapies that treat life-threatening diseases.

Fisher BioServices will expand its CryoHub solution by co-locating it with the Cell and Gene Therapy Catapult manufacturing center for seamless supply chain management and to accelerate cell and gene therapy production.

Pharmaceutical Technology spoke with Frank Generotzky, plant manager for Baxter BioPharma Solutions’ Halle, Germany facility, about operational excellence at the site.

The UK Stem Cell Bank released validated stem-cell lines for researchers developing novel cell-based therapies for clinical trials.

Sanofi and Lonza formed a joint venture to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.

The industry is becoming more consolidated, but there needs to be some strategy behind the mergers and acquisitions.

Under the agreement, Abzena will manufacture magacizumab, an antibody created using the ‘Abzena inside’ Composite Human Antibody technology.

The trends in the year 2017 will present the industry with new challenges, and companies will be able to meet them successfully if they focus on the issues at hand.

The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.

Aurobindo has added four cell-culture derived biosimilars to its product line.

EvaluatePharma and BioPharm International highlight the antibody-based therapeutics that may gain United States Regulatory approval in 2017.

Modular Automated Sampling Technology (MAST) allows direct aseptic transfer of bioreactor samples to analytical devices, providing rapid and reliable data in bioprocessing.

This three-year partnership will explore and identify new tools and methods to modify and optimize the Chinese hamster ovary (CHO) cell line performance.

The investment will be used to advance Nemaura’s R&D programs, which include liquid vaccines that have been reformulated for administration through the skin using its micropatch drug delivery technology.

According to results from the FOURIER trial, Repatha significantly reduced the risk of cardiovascular events and death in patients with atherosclerotic cardiovascular disease.

Pump systems must be designed to meet the needs of specific processes, including preventing cross-contamination and damage due to shear forces.

Alexandre Juillerat, PhD, innovation senior scientist at Cellectis, discusses novel construct UCART123, an investigational agent that is on deck to be the first gene-edited T-cell product in the United States.

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

ADMA will acquire BPC’s plasma-based fractionation and purification plant in Boca Raton, FL and plans to resolve issues at the facility noted in an FDA warning letter.

Researchers from Cellectis investigate how external signals in the tumor microenvironment could control the cell-surface expression and specificity of engineered CARs.