Contract Manufacturing

WuXi Biologics’ third site: First batch done, US client next

26-Jul-2018 By Flora Southey

WuXi Biologics completed its first manufacturing project at its 200,000 sq. ft. facility in Wuxi City earlier this week.

WuXi STA and Antengene partner under MAH scheme

24-Jul-2018 By Flora Southey

Antengene has selected CMO WuXi STA to develop and manufacture its mTOR inhibitor product ATG-008 for Chinese and Asia-Pacific markets.

DIA 2018

The nexus of innovation, policy improvements changing at never-before-seen pace: DIA

10-Jul-2018 By Melissa Fassbender

Cross-industry discussion is expanding from early discovery to post-licensing challenges – as the nexus of innovation and policy improvements is rapidly changing, says DIA executive.

Catalent eyes early-phase work with $133m Juniper acquisition

03-Jul-2018 By Melissa Fassbender

Catalent is set to acquire Juniper Pharmaceuticals in a $133m deal, which will provide the CDMO with a new European hub and the ability to win a larger share of early-phase development programs says exec.

Novacap acquires PCI Synthesis to expand offering in the US

20-Jun-2018 By Melissa Fassbender

France-based Novacap is set to acquire PCI Synthesis – a CDMO located near Boston’s biotech hub – to expand its pharmaceutical offerings in the US.

Life science advances and gender equity on the program for DIA 2018

19-Jun-2018 By Melissa Fassbender

This year’s DIA Global Annual Meeting will focus on the latest global trends and showcase the "diverse group of key individuals driving the life science ecosystem forward," says DIA Americas managing director.

Back to the future? The resurgence of combination drug products

19-Jun-2018 By Flora Southey

Drugmakers can greatly profit from developing a combination drug, but must address manufacturing and regulatory challenges in the early development stage, says Pharmatech Associates.

Recipharm buys Sanofi CMO site in UK, signs long-term supply deal

18-Jun-2018 By Flora Southey

Sanofi is handing off its Holmes Chapel facility and all existing contract manufacturing agreements to CDMO Recipharm.

mAb developer Oncobiologics launches CDMO business

15-Jun-2018 By Melissa Fassbender

Oncobiologics has launched a CDMO business to provide mAb development and manufacturing capabilities in a small biotech company setting, says CFO.

NEWS IN BRIEF

Alcami supporting commercial supply of Flexion’s first FDA-approved product

13-Jun-2018 By Melissa Fassbender

Alcami began work on Flexion Therapeutics's ZILRETTA in the fall of 2014 and today announced that it will further support commercial supply of the product, which is approved for the treatment of OA-related knee pain.

Cambrex expands in Italy and Sweden: New hires, labs to be ready in 2019

13-Jun-2018 By Melissa Fassbender

Cambrex’s news that it will be constructing a research and development laboratory at its Italy-based site follows on the heels of its recently announced plans to begin a $5m expansion in Sweden.

After raising $85m, SutroVax contracts Lonza to support vaccine development

12-Jun-2018 By Melissa Fassbender

Lonza is supporting SutroVax’s development of its pneumococcal conjugate vaccine candidate through an end-to-end supply relationship.

State of the Industry

State of the Industry: Taking the pulse of the contract services market

11-Jun-2018 By Melissa Fassbender

Following on from the success of last year's survey, Outsourcing-Pharma is running another 'state of the industry' survey to gauge views about the current state of the pharmaceutical contract services industry.

Smallpox treatment nears FDA approval after years of development, collaboration

11-Jun-2018 By Melissa Fassbender

SIGA is slated to receive FDA approval for the world’s first antiviral drug to treat smallpox – a milestone not reached in isolation, but in collaboration with several CROs, government agencies, and others.

Emergent initiates $50m expansion, expects to hire 60

07-Jun-2018 By Melissa Fassbender

Emergent BioSolutions has initiated a $50m multi-year expansion at the company’s Baltimore, MD-based fill/finish facility.

BIO 2018

Celltrion gets into outsourcing with Bio CDMO launch

06-Jun-2018 By Melissa Fassbender

Celltrion has launched Bio CDMO, its new contract development and manufacturing business and part of the company's "open innovation strategy" to expand its drug pipeline portfolio.

New PE owners say Alcami is ‘more than capable’ of doubling, tripling in size

05-Jun-2018 By Melissa Fassbender

Alcami Corporation is set to be acquired by MDP – a private equity firm which believes the CDMO could double or triple in size as a strong brand in a highly fragmented market.

Driven by ‘significant’ organic growth, Almac revenue tops £500m for first time

05-Jun-2018 By Melissa Fassbender

Almac Group has reported a 19% growth in revenue to £531m ($709.86m) – a first for the company as it continues to invest globally and drive a strategy of strategically entering new markets, says finance director.

CDMO Tedor Pharma recapitalizes following multi-million dollar investment

17-May-2018 By Melissa Fassbender

The newly-formed investment firm DORA Ventures has recapitalized Tedor Pharma, which recently completed a multi-million-dollar expansion of its manufacturing capabilities.

FDA issues new policy on defining an ‘outsourcing facility’

14-May-2018 By Brittany Farb Gruber

The US FDA has issued a policy that provides the proper definition of an outsourcing facility in an effort to ensure compounded drugs are made under appropriate quality standards.

WuXi AppTec IPO tops $353m

09-May-2018 By Melissa Fassbender

The Chinese contract research and development company WuXi AppTec has raised more than $353m in its initial public offering of common stock on the Shanghai Stock Exchange.

Chinese gov't outlines changes to import tariff, clinical trial applications, IP protection

07-May-2018 By Melissa Fassbender

Significant regulatory changes by the Chinese government will accelerate drug development timelines and positively affect sponsors’ bottom line, says CRO.

CordenPharma ups oligo API capacity at ex-Roche site

03-May-2018 By Flora Southey

CordenPharma has expanded its oligonucleotide active pharmaceutical ingredient manufacturing capacity in Colorado, US.

Cambrex hiring 12 new analytical scientists post $3.2m expansion

26-Apr-2018 By Melissa Fassbender

Cambrex has completed construction and validation of a new $3.2m, 11,000 square foot analytical laboratory at the former PharmaCore facility in High Point, NC.

Microbial CMO Wacker buys Dutch biotech plant

23-Apr-2018 By Melissa Fassbender

Wacker Chemie has acquired SynCo Bio’s site for manufacturing biopharmaceuticals, live microbial products, and vaccines, as well as its associated business, including more than 100 employees.

Mayne Pharma opens $80m facility, expands CDMO offering

19-Apr-2018 By Melissa Fassbender

Mayne Pharma has opened a new 126,000-square-foot oral solid-dose manufacturing facility to meet demand driven by new product launches – and new revenue stream from its CDMO business.

AMRI renews 10-year $39.5m drug discovery contract

17-Apr-2018 By Melissa Fassbender

AMRI will provide various services supporting drug discovery programs in neurotherapeutics as part of a 10-year contract worth up to $39.5m.

Catalent completes $5.5m expansion to help serve large-scale clinical studies

12-Apr-2018 By Melissa Fassbender

The delivery technologies and development solutions provider Catalent Pharma Solutions today announced it has completed a $5.5m expansion program at its 200,000+ square foot Philadelphia, PA.

DCAT WEEK

Pharma 'endangered,' though 'huge opportunities' exist as the industry evolves

10-Apr-2018 By Melissa Fassbender

Pharma must look outward to innovate and find new areas of growth, as research and development productivity and returns on innovation continue to decline, says industry expert.

Talk and tech: CMOs taking a stand at Interphex

10-Apr-2018 By Staff Reporter

The contract manufacturing industry will be represented at this year’s Interphex through a dedicated pavilion sponsored by advocacy group PBOA.

KBI, ReForm partnership about ‘bringing better biologics to patients,’ says CEO

05-Apr-2018 By Melissa Fassbender

KBI will provide services to ReForm to further develop and validate its biologic formulation platform and in turn, will gain access to ReForm’s proprietary excipient technologies.

AGC Biologics adds new facilities in Bothell, WA to support US growth

02-Apr-2018 By Melissa Fassbender

AGC Biologics has added a new building complex, which will house the company’s global headquarters, as the CDMO continues to expand in the US.

DCAT WEEK

CMOs, CDMOs give company updates at DCAT Week: Acquisitions, expansions on all sides

29-Mar-2018 By Melissa Fassbender

At DCAT Week, contract manufacturing and development companies from across the globe shared updates and news – from multi-million dollar investments to new business structures and areas of focus.

Abzena: Manufacturing suite remodel supports ADC production for preclinical, early-phase studies

28-Mar-2018 By Melissa Fassbender

Abzena has completed a remodeling of its new antibody-drug conjugate (ADC) GMP manufacturing suite, which will support customers progressing drug development programs from research into clinical trials.

CMO acquires 1.5-acre lot for new facility expected to launch in 2020

21-Mar-2018 By Melissa Fassbender

Grand River Aseptic Manufacturing has purchased a new lot of land to expand its manufacturing capabilities as growth in the market drives demand, says CEO.

What to expect at DCAT Week 2018

13-Mar-2018 By Melissa Fassbender

This year’s DCAT Week will focus on innovation in the pharmaceutical industry, with two new Executive Insights programs.

The Good, The Bad and the Ugly of CMO partnerships: A biotech perspective

13-Mar-2018 By Flora Southey

Partnering with CMOs makes sense for emerging biotechs, says Ardelyx exec James Kanter, who relies on networking and clear communication guidelines to manage third-party relationships.

CDMOs need to adapt to changing industry, reevaluate outlook and partnering models

13-Mar-2018 By Melissa Fassbender

CDMOs continue to take on a larger role supporting sponsors in the pharmaceutical industry, though new technology and changing requirements could shift the models in which they operate.

Update

PE-backed CMO expands syringe filling capabilities

06-Mar-2018 By Melissa Fassbender

Grand River Aseptic Manufacturing (GRAM) has purchased a new syringe filler to help meet "the rising demand" for parenteral development and manufacturing services.

News in Brief

CDMO BioDuro acquires Molecular Response

05-Mar-2018 By Melissa Fassbender

BioDuro has acquired Molecular Response LLC and its translational oncology research platform, which includes a biobank of more than 100,000 viable tumor specimens.

Almac opens £20m cold chain facility

28-Feb-2018 By Melissa Fassbender

Almac Group has opened a 95,000 square foot, custom-built cold store facility, which is one of the largest of its kind in Europe, says CDMO.

AMRI expanding testing services in EU as European client base grows

28-Feb-2018 By Melissa Fassbender

AMRI is expanding its container closure integrity testing (CCIT) services in the European Union (EU), with further services to be added later in 2018.

People on the move

Outsourcing-Pharma’s Hiring and Firing Roundup February ‘18

28-Feb-2018 By Melissa Fassbender

CordenPharma has revamped its executive leadership team, Recipharm has named the head of its new global development organization, and several new CEOs have been appointed.

Avid wins commercial manufacturing project from Roivant

21-Feb-2018 By Melissa Fassbender

Avid Bioservices has been selected to manufacture a commercial drug substance for Enzyvant, a subsidiary of Roivant Sciences, which is developing a therapy to treat Farber disease.

West Pharma to merge manufacturing and exit sites in network shake-up

21-Feb-2018 By Flora Southey

A network reshuffle will see West Pharma consolidate manufacturing and close some facilities to “streamline” its plant network.

Avid raises $20m, working ‘aggressively’ to grow CDMO business

20-Feb-2018 By Melissa Fassbender

Avid Bioservices expects new contractual commitments in the coming weeks and months after raising more than $20m and completing its transition to a dedicated CDMO, says CEO.

Scientist.com implementing process to address global requirements ahead of GDPR

19-Feb-2018 By Melissa Fassbender

Scientist.com is working to implement an improved contractual landscape ahead of GDPR implementation in May, in order to ensure global compliance among sponsors and CROs.

Denali signs Lonza to make biologics in first CMO deal

12-Feb-2018 By Flora Southey

Lonza has inked a biologics deal with Denali to make neurodegenerative disease therapies, offering the Californian firm opportunity to have production “on their back doorstep.”

Cambrex up on innovator API demand, aims for double-digit growth

12-Feb-2018 By Dan Stanton

Cambrex Corporation says a preference among reference drugmakers for Western made APIs has helped produce robust quarterly results.

Vetter securing customer commitments ahead of groundbreaking at US site

06-Feb-2018 By Melissa Fassbender

Vetter is talking with customers to create a “stable financial plan” that will justify the manufacturer’s previously announced $320m investment for a new facility, which is not expected to break ground before 2022.