At CPhI Worldwide 2015, The Dow Chemical Company announced the global commercial availability of AFFINISOL HPMC HME, a new generation of cellulosic polymer for drug solubilization. The polymer is designed for use by pharmaceutical companies looking to enhance the solubilization and inhibit the recrystallization of APIs in hot-melt extrusion (HME) formulations.
Catalent Pharma Solutions won the “Innovation in Process and Formulation Development” category at the annual CPhI Pharma Awards, for its OptiShell softgel technology platform.
CDMO Aesica Pharmaceuticals introduced a new service approach in which the company will taks on the management of other CDMOs, while serving as the single, central point of customer contact, the company announced in an Oct. 14, 2015 press release.
Ajinomoto Althea, a biopharmaceutical CDMO, is expanding its existing biological drug product manufacturing operations to include highly active materials, such as antibody-drug conjugates (ADCs), the company announced on Oct. 14, 2015. The new facility is located in close proximity to the company’s existing operations in San Diego, CA.
The joint marketing agreement allows the companies to expand dedicated blister feed system technologies.
Celebrating the best of pharma and recognizing companies that turn inspiration into innovation.
The company presented a portfolio of new products during the meeting in Madrid.
The new sugars are touted to increase the efficacy of active pharmaceutical ingredients and improve cell culture yield.
In the past, contract manufacturing organizations (CMOs) and contract development manufacturing organizations (CDMOs) have been focused most on achieving scale, reaching new clients in new geographic regions, and adding services that were previously unavailable, according to Gil Y. Roth, president of the Pharma and Biopharma Outsourcing Association. In a new report from CPhI, Roth explicates how consolidation has changed how CMOs position their services to clients and how CMOs add value to their businesses.
A CPhI report suggests that the pharma industry should be careful not to outsource to lower labor-cost countries rather than investing in manufacturing technology and innovation.
A CPhI report predicts how two potential mega free-trade deals, one among Pacific-Rim countries and the other between the US and EU, could affect pharmaceutical companies.
The European Medicines Agency plans on using existing patient registries to collect information on medicines.
Cell Therapy Catapult will provide manufacturing scale-up services to enable Asterias’ future clinical trials and commercial supply for Asterias’ allogeneic dendritic cell immunotherapy, AST-VAC2.
Biogen, Sobi, and the World Federation of Hemophilia collaborated to enable a sustained humanitarian supply of hemophilia treatment to developing countries, and the first shipments have begun to arrive.
Stefan Oschmann will replace new Karl-Ludwig Kley as chairman of the executive board and CEO of Merck KGaA.
Test results of the new multilayer plastic container show that it offers sensitive pharmaceuticals extra protection against moisture vapor and oxygen permeability.
Grace and Formac Pharmaceuticals have announced SilSol 6035 Mesoporous Silica Gel, the first silica in the Grace silica-based drug delivery platform. The silica gel is the result of a multi-year collaboration between the companies.The platform was engineered to offer a new drug delivery option for APIs with poor aqueous solubility (BCS class 2 compounds), Grace reports and combines the company’s expertise in mesoporous silica gel and novel application methods to accelerate the screening and development of stable, amorphous-based systems.
Contract manufacturer PiazaBio announces services for Western Pharma companies seeking to enter the China market.
The Cell History File is designed as a “cell passport” for developers and manufacturers of tissue- and cell-based medicinal products.
Probiodrug has signed an agreement with Rentschler Biotechnologie GmbH for the development of PBD-C06, a pGlu-Abeta-specific monoclonal antibody, as treatment for patients with Alzheimer’s disease.
The new facility will house the company’s expanding R&D operations.
The agency provides recommendations for submitting proposed labeling with abbreviated new drug applications.
The PDA report discusses qualification and operational handling of passive thermal protection systems.
3M and Impel will collaborate to develop and commercialize Impel’s Precision Olfactory Delivery technology for enhanced central nervous system drug delivery.
Researchers in the US, Japan, and China are recognized for developing therapies to combat river blindness, lymphatic filariasis, and malaria.
Merck Millipore’s collaboration with celares GmbH launches pegylation services for protein-based therapeutics.
FDA selected USDM Life Sciences, RC Partners, and The Clarion Group to develop and implement a DSCSA pilot project.
Vetter plans to invest approximately 300 million Euros during the course of five years to expand drug product manufacturing and logistic services in Germany; upgrades will include an improved RABS system for aseptic processing.
CPhI’s Annual Report discusses the implications of QbD, continuous processing, excipient criticality, and process validation on pharmaceutical manufacturing and predicts a steady shift to continuous manufacturing.
BASF completes sale of custom synthesis business and parts of its API business to Siegfried Holding.
