Upstream Processing

ABEC, an equipment and engineering company, will provide a custom-made, single-use bioreactor to custom manufacturing firm, Emergent, for its Maryland manufacturing facility.

The company announced plans to expand its viral vector process development facilities in the United States and its cleanroom facilities in the Netherlands for vector-based products.

The companies have entered into a strategic collaboration to establish a new cell therapy and regenerative medicine manufacturing platform, which includes a new manufacturing facility in Belgium.

Under an agreement, ProBioGen will develop a stable cell-line for and manufacture an anti-cancer antibody for Chiome using its proprietary cancer cell-killing technology.

Groninger will showcase its FlexPro 50 line for small batch production at CPhI Worldwide 2017, and present on up- and downstream processes with freeze-dryer developer and manufacturer Martin Christ.

Sartorius begins building a new, EUR 30-million (US$35.2 million) Cell Culture Technology Center in Ulm, Germany.

Detecting viral contaminants in biologic-based medicines-and identifying their source-requires a holistic testing approach.

. This study is an attempt to produce a fusion protein by binding the fragment NT-gp96 in upstream of sequence of the N terminal fragment (NT300) of the NS5B gene in an expression vector.

Traditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.

Consider automation early in the rollout of clinical translation and scale up of clinical-trial protocols.

Modeling tools help process engineers optimize a biopharmaceutical facility’s capacity.

FDA noted in a recent inspection that US Stem Cell Clinic was processing and administering stem cell treatments that were neither reviewed nor approved by the agency.

AstraZeneca and Champions will develop new cohorts of patient-derived xenograft models to be used in oncology programs in breast and lung cancer as well as for use in other academic and industry applications.

The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.

Pfizer will invest $100 million to expand its manufacturing facilities in Sanford, North Carolina.

Amid debate about “fake news,” peer-review papers offer vital, objective insight.

Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

ABEC increases the maximum capacity of its Custom Single Run Bioreactors to 4000 L, doubling the industry standard.

The authors present a shift toward more integrated purification processes.

Perfusion processes can attractive for biologics drug manufacturing; however, obstacles remain.

Continuous processing of 100 g of monoclonal antibody in 24 hours has been demonstrated using lab-scale equipment.

Traditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.

Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.

The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.