Contract Manufacturing, General

The inaugural Connect in Pharma event will take place on 14 and 15 September in Geneva, Switzerland.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the basics for maintaining an acceptable working relationship between a client and their CDMO.

Experts discuss what data to consider when selecting a high-potential drug candidate and how AI can be harnessed in medicinal chemistry drug discovery.

Industry experts share their top outsourcing tips from both the perspective of companies offering outsourcing services as well as for companies looking to outsource.

CDMOs need to consistently demonstrate agility as demand increases for newly developed therapeutic modalities.

Cyxone has appointed a European CDMO to scale-up and produce the active ingredient of its T20K drug candidate.

A new focus on speed to market creates challenges for facility design and construction.

Sterling Pharma Solutions has announced a £10 million (US$13.5 million) investment into process development and manufacturing capacity at its site in Dudley, UK.

MilliporeSigma announced the opening of its second Carlsbad, California-based facility, which doubles production capacity to support commercial and industrial manufacturing of viral vectors.

An effective data structure and simple communication between production, logistics, and sales are essential for delivering this level of accountability, traceability, and security.

Investments, biologics, and the impact of COVID-19 will continue to shape the bio/pharmaceutical outsourcing industry for the near term.

There are some key questions that should be asked by both the sponsor company and the outsourcing partner before undertaking a method development project.

The CRO market will see greater consolidation by both financial buyers looking to consolidate smaller players and larger CRO players wanting to expand into value-added specialty service areas.

AMRI reinforces positioning as a CDMO with name change and acquires the formulation and fill/finish company, Integrity Bio, and biologics company, LakePharma.

CMOs and CDMOs adjust business processes as demand for COVID-19 treatments and non-pandemic related therapies puts pressure on the bio/pharma industry.

Catalent expands capabilities for stem cell-based therapies with acquisition of RheinCell’s GMP-grade human iPSCs.

Vectura will provide preclinical development services for Incannex’s inhaled drug product for the treatment of traumatic brain injury.

Despite the COVID-19 pandemic, the industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.

Executives that participated in the CPhI post-pandemic survey are predicting a push for repatriation of manufacturing globally.

Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.

Celonic will manufacture CvnCoV at its facility in Germany.

A digital system makes real-time inventory, production, distribution, and shipping information readily accessible.

The rapid and efficient delivery of innovative treatments through the COVID-19 pandemic has demonstrated the value of collaborations within the bio/pharma industry.

Outsourcing increases as the industry balances development and manufacturing of both COVID-19 treatments and non-pandemic-related medicines.

Catalent has signed an agreement with Bone Therapeutics for the acquisition of Skeletal Cell Therapy Support SA (SCTS).

3P Biopharmaceuticals, and Oxford University spin-out, SpyBiotech, have signed a vaccine contract manufacturing agreement.

The radiopharmaceutical CDMO is building a new cGMP facility in Springfield, NJ.

Contract service providers offer vital services to bio/pharma companies of all sizes. Establishing an effective working relationship and managing operations are key to avoiding compliance issues.

Sterling Pharma Solutions has signed a deal with Moleculin Biotech to support the development of WP1122, a potential COVID-19 treatment.

Demand for custom drug delivery solutions is increasing and bringing forth an exciting period of valuable, innovative development opportunities.