Contract Manufacturing

WuXi Biologics and Almirall partner to develop dermatological treatments

09-Jan-2020 By Vassia Barba

Almirall enters drug discovery agreement with WuXi Biologics, gaining access to the WuXiBody platform to develop antibodies for the treatment of dermatological diseases.

CMO problems prompt Innate to put trial on partial hold

24-Dec-2019 By Nick Taylor

Innate Pharma stops dosing new patients in clinical trial amid problems at manufacturing partner.

3M set to sell biopharma-focused CDMO for $650m

23-Dec-2019 By Nick Taylor

3M agrees to sell drug delivery contract service unit to investment group Altaris Capital Partners.

Avid frames Halozyme setback as potential positive for CDMO business

19-Dec-2019 By Nick Taylor

Avid Bioservices sees potential upside to clinical development setback at big customer Halozyme.

Sanofi to 'optimize' CMOs to drive down spending

18-Dec-2019 By Nick Taylor

Sanofi plans “optimization of CMOs and suppliers” as new CEO targets €2bn in savings by 2022.

Antibe engages global CMO to support planned pain drug partnership

16-Dec-2019 By Nick Taylor

Antibe tasks global CMO with providing a reliable supply of pain drug, ATB-346.

Ex-Covance CEO Ratliff takes over as head of AMRI

13-Dec-2019 By Nick Taylor

Ex-Covance leader John Ratliff replaces Michael Mulhern as CEO of AMRI.

Novartis sets 2020 target for commercial readiness of cell therapy CMO

10-Dec-2019 By Nick Taylor

Novartis aims to have its Japanese cell therapy CMO commercially ready in the second half of 2020.

BerGenBio taps into Piramal’s platform to develop leukemia treatment

09-Dec-2019 By Vassia Barba

Piramal to support the development of BerGenBio’s treatment for acute myeloid leukemia, after the US FDA granted the candidate fast track designation.

GE Healthcare launches automation software for CAR-T manufacturing

05-Dec-2019 By Vassia Barba

GE Healthcare tops its C-Pro cell processing system with SpinOculation, an automation software that enables closed T cells transduction at the preferred volume and concentration.

Entera tips contract manufacturing investments to give it an edge

03-Dec-2019 By Nick Taylor

Entera Bio tips investments in manufacturing to give it an edge by driving down the cost of making its products.

‘Insatiable’ demand drives up expectations for Catalent's gene therapy unit

03-Dec-2019 By Nick Taylor

Analyst increases estimate of revenue potential of Catalent’s gene therapy unit in light of ‘insatiable’ demand.

Thermo Fisher expands site, boosts biologics processing offering

28-Nov-2019 By Vassia Barba

Thermo Fisher Scientific doubles the capacity of its gene therapy and viral vector processing facility in Alachua, Florida, to provide scalability to customers.

Recro spins out Baudax to boost CDMO focus

28-Nov-2019 By Vassia Barba

Recro Pharma announces the separation of its acute care business to launch Baudax Bio as a developer of products, including non-opioid analgesics, to concentrate on its CDMO business.

Ascendis builds up secondary supplier to support global TransCon expansion

26-Nov-2019 By Nick Taylor

Ascendis builds up secondary supplier to secure manufacturing capacity for planned global rollout of TransCon growth hormone.

Recipharm strikes £505M takeover of Consort

25-Nov-2019 By Nick Taylor

Recipharm strikes £505m takeover of Consort Medical to leapfrog into top tier of CDMOs.

Zosano readies contract manufacturers for pre-approval inspections

25-Nov-2019 By Nick Taylor

Zosano Pharma prepares contract manufacturers to host pre-approval inspections to support filing for approval of migraine drug.

Teva spinout eyes outsourced manufacturing scale up after $85M IPO

21-Nov-2019 By Nick Taylor

89bio plans to invest up to $10m (€9m) in manufacturing and scale up, after raising $85m in an upsized IPO.

Fujifilm expands gene therapy analytical services with $55m lab

21-Nov-2019 By Vassia Barba

Fujifilm Diosynth opens a 60,000-square-feet Gene Therapy Innovation Center to support upstream, downstream and analytical development services.

Editas touts manufacturing benefits of teaming up with AskBio

20-Nov-2019 By Nick Taylor

Editas Medicine points to AskBio’s ‘excellent manufacturing facility’ and associated expertise to explain benefits of recent partnership.

Forty Seven ramps up contract manufacturing spending

19-Nov-2019 By Nick Taylor

Forty Seven records 50% increase in R&D spending, as contract manufacturing costs ramp up.

Dupixent drives up Regeneron spending on contract manufacturing

14-Nov-2019 By Nick Taylor

Regeneron Pharmaceuticals increases spending on collaboration and contract manufacturing by 39% on rising Dupixent sales.

Mallinckrodt looks to grow CMO business to offset opioid headwind

12-Nov-2019 By Nick Taylor

Mallinckrodt talks up prospect of contract manufacturing growth offsetting opioid headwind faced by its speciality generics business.

Dr. Reddy’s taps contract manufacturer to access Chinese market

11-Nov-2019 By Nick Taylor

Dr. Reddy’s Laboratories moves products to Chinese contract manufacturer in push to access major emerging market.

CPhI Worldwide 2019

Exothermic reactions at -60°C for continuous API manufacture

11-Nov-2019 By Vassia Barba

Driven by market demand, De Dietrich develops an API production set that enables continuous manufacturing of molecules that require exothermic chemical reactions.

Samsung takes on clinical manufacturing of Ichnos’ mAb candidate

06-Nov-2019 By Vassia Barba

Samsung continues an agreement formerly signed with Glenmark to manufacture Ichnos’ mAb treatment candidate for atopic dermatitis, as the product enters Phase III clinical trials.

CPhI Worldwide 2019

Patient centricity to 'change CDMO business internally': Piramal

06-Nov-2019 By Vassia Barba

Speaking at CPhI 2019, Piramal CCO puts the spotlight on patients who ultimately 'pay the bill,' and explains how this mentality could reshape the CDMO business.

People on the Move: Outsourcing-Pharma roundup October ‘19

01-Nov-2019 By Melissa Fassbender

This month’s people on the move includes a new therapeutic lead at Advanced Clinical, with plans to create a network of investigation sites, as well as CEOs at AIT Bioscience and Pharm-Olam, who discuss plans for moving forward.

Robots lend a hand in secondary packaging

31-Oct-2019 By Melissa Fassbender

Vetter recently completed a successful pilot project to automate aspects of its secondary packaging series with the use of a dual-arm robot – which provides a high degree of continuity and precision, says CDMO.

ANI launches CDMO arm after WellSpring integration

31-Oct-2019 By Vassia Barba

ANI Pharmaceuticals expands into the CDMO market and introduced its services for late-stage developers at CPhI last week.

BIA Separations adds to Cornerstone vector development program

16-Oct-2019 By Vassia Barba

An expansion to BIA Separations' Cornerstone set of processing services for viral vector development adds the use of kryptonase and CIMmultus chromatography device.

Lonza in deal to manufacture Cellectis’ UCART oncology pipeline

03-Oct-2019 By Vassia Barba

Cellectis chooses Lonza to take on the clinical manufacturing of its UCART blood cancer immunotherapy candidates, intended to be marketed as industrialized, readily available CAR-T cells.

Almac joins clinical supply blockchain working group

24-Sep-2019 By Vassia Barba

Almac joins a working group made up of clinical supply chain industry members, in order to contribute to the use case discussion about blockchain technology.

Early manufacturing life-saving for biologics developers, says CMO exec

23-Sep-2019 By Vassia Barba

‘Talk to your CDMO early’ is the advice BioConnection gives to developers of biopharmaceuticals, suggesting that they make a reservation to ensure availability.

Vineti, Cryoport partner to extend end-to-end cell therapy logistics offering

10-Sep-2019 By Vassia Barba

A collaboration between Vineti and Cryoport aims to extend supply chain services as the cell and gene therapies space continues to scale.

Catalent adds to its clinical supply business with new facility

09-Sep-2019 By Vassia Barba

Catalent to invest $9m in the building of an early-stage clinical supply facility in San Diego, due to open in the summer of 2020, to integrate its CDMO business.

Velesco acquires facility, triples clinical manufacturing capacity

05-Sep-2019 By Vassia Barba

Velesco to triple its capacity for non-sterile clinical material manufacturing and consolidate its cGMP capabilities with the purchase of a facility in Wixom, Michigan.

People on the Move: Outsourcing-Pharma roundup August ‘19

04-Sep-2019 By Melissa Fassbender

The last month of summer saw several hires, including a lead for Worldwide Clinical Trials’ Japan operations, CEO appointments at CordenPharma and LabConnect, and Altasciences’ new CSO, who joins the company from Syneos.

Orgenesis reports record revenue as it looks to develop scalable processing solutions for cell therapies

03-Sep-2019 By Melissa Fassbender

Orgenesis is developing a ‘distributed’ processing solution – backed by its point-of-care cell therapy platform and CDMO business – to provide approved cell therapies to patients at a fraction of today’s costs, says company executive.

Lonza and Chr. Hansen kickstart BacThera JV with €90m

02-Sep-2019 By Vassia Barba

Chr. Hansen and Lonza name their joint venture CDMO for live biotherapeutics and ready the launch after receiving antitrust approvals.

Chinese CDMO contracted to manufacture Pfizer’s oncology candidate

27-Aug-2019 By Vassia Barba

CMAB Biopharma to support Kintor in the clinical development of a potential treatment for liver cancer, ahead of regulatory filing.

Cellular therapy CDMO Cognate closes growth capital round

27-Aug-2019 By Maggie Lynch

Cognate BioServices closes a round of growth capital from EW Healthcare Partners to secure its capabilities for the commercialization of advanced cellular therapies.

Cancer Research UK backs Hummingbird’s cancer treatment development

13-Aug-2019 By Vassia Barba

Cancer Research UK to support the clinical development of Hummingbird’s investigative cancer treatment which has the potential to fight drug resistant tumours.

The complete package: Sartorius Stedim adds cell bank manufacture

12-Aug-2019 By Maggie Lynch

Sartorius Stedim to offer the GMP manufacture of mammalian cell banks for the biopharmaceutical industry alongside characterization services.

Permira Funds acquires Cambrex in $2.4bn deal

08-Aug-2019 By Vassia Barba

Cambrex is acquired by an affiliate of Permira Funds for $2.4bn, and will continue investing ‘aggressively’ to support its global customer base.

People on the Move: Outsourcing-Pharma roundup July ‘19

02-Aug-2019 By Melissa Fassbender

CordenPharma has a new CEO, Arbour Group advances plans to expand in RTP, Ashfield brings on a former Iqvia VP, and Recursion adds to its c-suite after raising $121m this month.

Quotient to ‘stretch’ core CDMO business with new PE owners

22-Jul-2019 By Melissa Fassbender

Quotient Sciences has found new owners in the UK-based PE firm, Permira, as the CDMO eyes new opportunities to expand its business into adjacent service sectors and new geographies, says CEO.

Reactor malfunction results in employee death at India-based CRO

11-Jul-2019 By Melissa Fassbender

One worker has died at GVK Bio’s Hyderabad site after a reactor malfunctioned, though the root cause remains unknown, according to the CRO.

Wasdell opens doors at EU headquarters

08-Jul-2019 By Melissa Fassbender

The company initiates operations at its new EU headquarters in Dundalk, Ireland after receiving its manufacturing and importation authorization license from the HPRA.

People on the Move: Outsourcing-Pharma roundup June ‘19

03-Jul-2019 By Melissa Fassbender

Newly-minted Signant Health named a new CTO, Parexel bolstered its Japan presence, and BioAgilytix’s CEO was appointed to the board of FSD Pharma – a company developing products based on cannabinoids – among other people on the move in June.

Product Innovations

Generic method approach for determination of residual solvents in active pharmaceutical ingredients by gas chromatography

Solvents are defined as organic chemicals that are used to dissolve components. They are used during the manufacture of drug substances and can also potentially...

Pulmonary Delivery of Orally Inhaled Therapeutics

New classes and indications of orally inhaled therapeutics are rapidly expanding, with the development pipeline increasingly featuring both large and small...

Addressing Challenges with Clinical In-Use Testing

Lonza Drug Product expert Léa Sorret PhD explores Clinical In-Use Testing of Biotherapeutics in this white paper. Léa shares her expertise and describes...

Outsourcing-Pharma

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