Outsourcing

Quotient Clinical’s addition of CDMO QS Pharma increases the company’s footprint in the US an adds high potency molecule capability.

The outlook for the CMO and CDMO industry may be affected by ever-changing politics.

Analytical products for improved bio/pharmaceutical development.

Cold-chain requirements and the tight logistical windows needed for cell and gene therapies demand a focus on early communication and risk mitigation.

Andrea Zobel, senior director of product management, clinical trial supply, and logistics at PAREXEL International, examines key issues and questions that sponsors and contract partners must address.

Many pharmaceutical manufacturers were late in involving contract partners in serialization efforts. Are you ready, and are you working with the right partner?

As the date for implementation of the Drug Supply Chain Security Act approaches, bio/pharma companies and contractors should focus on key areas.

Selecting the best partner contract service and fostering a successful relationship requires detailed research and effective communication.

Currently, pharmaceutical manufacturers are said to waste $25 billion on supply chain inefficiencies. Technology offers a way to achieve transparency and results.

Supply chain risk monitoring is crucial for any company doing business today, and it doesn’t have to be expensive.

More life-sciences companies are starting to manage global suppliers holistically.

By working together and taking a QA-based approach, manufacturers and suppliers can reduce raw material testing requirements.

SGS invested in test equipment for analyzing extractables and leachables at its New Jersey laboratory.

Vetter expanded visual inspection facilities and controlled-temperature storage at its Ravensburg Vetter West facility in Germany.

WuXi AppTech acquired HD Biosciences, a preclinical drug-discovery-focused CRO.

Camfil Air Pollution Control has expanded its testing laboratory and added a dust collection test rig for the ANSI dust collection standard.

EAG Laboratories offers dermal absorption studies using OECD methods.

High Street Capital acquired Avomeen, a full-service chemical testing laboratory, in late December 2016

UK-based Orchard Therapeutics and PharmaCell ally to support clinical trials and commercialization of Orchard’s ex-vivo gene therapies.

Catalent announces a development agreement with JOT to evaluate softgel options for a resveratrol drug candidate.

Robust venture capital investment gives CDMOs and CROs a positive outlook for 2017.

Healthcare policies, R&D investments, and drug approvals will test bio/pharma.

Pharma Tech introduced a new high-speed bottling line to its facility in Union, MO.

AGC adds second biopharma contract manufacturer with acquisition of CMC Biologics.

Novasep’s three facilities located in France and Germany are free of Form 483.

The company has manufactured double-digit number of batches on the new filling line, for use in early-stage clinical trials.

BMS changes its US geographic footprint with R&D investments and closures.

At the American Society of Hematology Annual Meeting, Novartis and Kite Pharma both released results from early-phase clinical trials with CAR-T therapies.

M&A activity, new business models, fundraising limits, offerings from small CDMOs, and combination products are driving decisions in the contract services market..

Biosimilars may be the key to CMO growth.